Baixe o app para aproveitar ainda mais
Prévia do material em texto
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=idre20 Disability and Rehabilitation ISSN: 0963-8288 (Print) 1464-5165 (Online) Journal homepage: http://www.tandfonline.com/loi/idre20 Improvement in clinical outcomes after dry needling versus myofascial release on pain pressure thresholds, quality of life, fatigue, pain intensity, quality of sleep, anxiety, and depression in patients with fibromyalgia syndrome Adelaida M. Castro Sánchez, Hector García López, Manuel Fernández Sánchez, José Manuel Pérez Mármol, María Encarnación Aguilar-Ferrándiz, Alejandro Luque Suárez & Guillermo Adolfo Matarán Peñarrocha To cite this article: Adelaida M. Castro Sánchez, Hector García López, Manuel Fernández Sánchez, José Manuel Pérez Mármol, María Encarnación Aguilar-Ferrándiz, Alejandro Luque Suárez & Guillermo Adolfo Matarán Peñarrocha (2018): Improvement in clinical outcomes after dry needling versus myofascial release on pain pressure thresholds, quality of life, fatigue, pain intensity, quality of sleep, anxiety, and depression in patients with fibromyalgia syndrome, Disability and Rehabilitation, DOI: 10.1080/09638288.2018.1461259 To link to this article: https://doi.org/10.1080/09638288.2018.1461259 Published online: 23 Apr 2018. Submit your article to this journal Article views: 198 View Crossmark data http://www.tandfonline.com/action/journalInformation?journalCode=idre20 http://www.tandfonline.com/loi/idre20 http://www.tandfonline.com/action/showCitFormats?doi=10.1080/09638288.2018.1461259 https://doi.org/10.1080/09638288.2018.1461259 http://www.tandfonline.com/action/authorSubmission?journalCode=idre20&show=instructions http://www.tandfonline.com/action/authorSubmission?journalCode=idre20&show=instructions http://crossmark.crossref.org/dialog/?doi=10.1080/09638288.2018.1461259&domain=pdf&date_stamp=2018-04-23 http://crossmark.crossref.org/dialog/?doi=10.1080/09638288.2018.1461259&domain=pdf&date_stamp=2018-04-23 ORIGINAL ARTICLE Improvement in clinical outcomes after dry needling versus myofascial release on pain pressure thresholds, quality of life, fatigue, pain intensity, quality of sleep, anxiety, and depression in patients with fibromyalgia syndrome Adelaida M. Castro S�ancheza, Hector Garc�ıa L�opezb, Manuel Fern�andez S�ancheza, Jos�e Manuel P�erez M�armolc, Mar�ıa Encarnaci�on Aguilar-Ferr�andizc, Alejandro Luque Su�arezd and Guillermo Adolfo Matar�an Pe~narrochae aDepartment of Nursing, Physical Therapy and Medicine, University of Almeria (UAL), Almeria, Spain; bDepartment of Physical Therapy, Andalusian Health Service, Primary Health Physical Therapy, Almeria, Spain; cResearch Institute – Biosanitaria Granada (IBS – Granada), Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain; dDepartment of Physical Therapy, Faculty of Health Sciences, University of Malaga (UMA), Malaga, Spain; eMalaga Health District, Andalusian Health Service, Primary Health Medical, Malaga, Spain ABSTRACT Purpose: To compare the effectiveness of dry needling versus myofascial release on myofascial trigger points pain in cervical muscles, quality of life, impact of symptoms pain, quality of sleep, anxiety, depres- sion, and fatigue in patients with fibromyalgia syndrome. Method: A single-blind randomized controlled trial was conducted. Sixty-four subjects with fibromyalgia were randomly assigned to a dry needling group or a myofascial release group. Pain pressure thresholds of myofascial trigger points were evaluated in the cervical muscles. In addition, quality of life, impact of fibromyalgia symptoms, quality of sleep, intensity of pain, anxiety and depression symptoms, impact of fatigue at baseline and post treatment after four weeks of intervention were evaluated. Results: Significant improvement was found in most pain pressure thresholds of the myofascial trigger points in cervical muscles in the dry needling group compared to myofascial release (p< 0.05). Similarly, these differences between groups were found for the components of quality of life of physical function (F¼ 12.74, p¼ 0.001), physical role (F¼ 11.24, p¼ 0.001), body pain (F¼30.26, p< 0.001), general health (F¼ 15.83, p< 0.001), vitality (F¼ 13.51, p¼ 0.001), social function (F¼ 4.73, p¼ 0.034), emotional role (F¼ 8.01, p¼ 0.006), and mental health (F¼ 4.95, p¼ 0.030). Similar results were achieved for total impact of FMS symptoms (F¼ 42.91, p< 0.001), quality of sleep (F¼ 11.96, p¼ 0.001), state anxiety (F¼ 7.40, p¼ 0.009), and trait anxiety (F¼�14.63, p< 0.001), hospital anxiety and depression (F¼ 20.60, p< 0.001), general pain intensity (F¼ 29.59, p< 0.001), and fatigue (F¼�25.73, p< 0.001). Conclusion: The dry needling therapy showed higher improvements in comparison with myofascial release therapy for pain pressure thresholds, the components of quality of life of physical role, body pain, vitality and social function, as well as the total impact of FMS symptoms, quality of sleep, state and trait anxiety, hospital anxiety-depression, general pain intensity and fatigue. � IMPLICATIONS FOR REHABILITATION � Dry needling therapy reduces myofascial trigger point pain in the short term in patients with fibro- myalgia syndrome. � This therapeutic approach improves anxiety, depression, fatigue symptoms, quality of life, and sleep after treatment. � Dry needling and myofascial release therapies decrease intensity of pain, and the impact of fibromyal- gia symptoms in this population. � These intervention approaches should be considered in an independent manner as complementary therapies within a multidisciplinary setting. ARTICLE HISTORY Received 18 October 2017 Revised 27 February 2018 Accepted 2 April 2018 KEYWORDS Chronic fatigue disorders; physical therapy modalities; musculoskeletal pain; disability; mood disorders; rehabilitation research Introduction Fibromyalgia syndrome (FMS) is characterized by chronic and dif- fuse musculoskeletal pain. The prevalence has been estimated as 4.7% of inhabitants in Europe [1]. Although the exact cause of fibromyalgia is unknown, abnormalities of the nervous system regarding pain processing may explain the chronic pain. Several studies have reported that subjects with FMS show hyper-responsiveness and hyper-excitability of the central nervous system (central sensitization) [2–4]. The relationship between cen- tral sensitization and peripheral pain nociception can be sup- ported because central hyper-excitability is influenced by prolonged nociceptive peripheral inputs [5]. In fact, nociceptive stimuli from muscle tissue seem to contribute to FMS [6,7]. Conditioned pain modulation has a specific role in pain gener- ation, influencing pain perception and its prevention. Evidence CONTACT Adelaida M. Castro S�anchez adelaid@ual.es Department of Nursing, Physical Therapy and Medicine, Faculty of Health Sciences, University of Almer�ıa, Ctra. Sacramento s/n. La Ca~nada de San Urbano, Almer�ıa 04120, Spain � 2018 Informa UK Limited, trading as Taylor & Francis Group DISABILITY AND REHABILITATION, 2018 https://doi.org/10.1080/09638288.2018.1461259 http://crossmark.crossref.org/dialog/?doi=10.1080/09638288.2018.1461259&domain=pdf http://www.tandfonline.com has shown that dysfunctional conditioned pain modulation occurs prior to the acquisition of pain and an improvement in condi- tioned pain modulation reduces the levels of clinical pain [7]. Myofascial trigger point (MTrPs) pain is defined as pain caused by one or more hyperirritable spots in the skeletal muscle that are related to hypersensitivity palpable nodules in taut bands [8]. Alonso-Blanco et al. [9] reported that local and referred pain from widespread active MTrPs fully reproduced the overall spontaneous clinical pain area in patients with FMS. Simons et al. [10] sug- gested that MTrPs can play an important role in the treatment of pain in FMS. Patients with FMS usually present multiple active trigger points,which are related to generalized pressure hyper- algesia, and contribute to regional pain. In fact, trigger points have been considered the main peripheral pain generator in this population. Peripheral inputs from active MTrPs may lead to cen- tral sensitization of FMS patients [9]. Staud et al. [11] concluded that the overall spontaneous pain is located in certain body areas. Local and referred pain has been induced from active trigger points identified in the trapezius muscle, which reproduced neck- shoulder pain patterns in FMS [12]. Previous studies have sug- gested that the number of active MTrPs found in patients with FMS is directly related to pain intensity [9,13–15]. Lucas et al. [13] reported that latent MTrPs in the scapular rotator muscles change the muscle activation pattern of this muscle group and of muscles further distal in the shoulder girdle kinetic chain. Low levels of quality of life and quality of sleep, and high lev- els of fatigue, anxiety and depression symptoms have been reported in FMS patients. It would be expected that the improve- ment in MTrPs and pain after physical therapy interventions may also have an influence on these health areas [16–18]. Dry needling is a minimally invasive technique in which an acupuncture needle is inserted directly into MTrPs [8]. Previous research has documented the immediate reduction in local and referred pain after dry needling [19–21]. However, the effective- ness of dry needling has been discussed in scientific literature. In some studies, no beneficial effects have been observed [22] and others have reported it to be effective on trigger points [23,24]. Dry needling seems to be effective on acute and chronic low back pain, lumbar myofascial pain, headaches, chronic lumbar MTrPs, and whiplash [25–30]. A systematic review concluded that direct needling of MTrPs seems to be superior to no therapeutic inter- vention, but the hypothesis that needling therapies have efficacy beyond the placebo effect is neither supported nor refuted by the evidence from clinical trials [22]. A previous study showed that dry needling is effective on MTrPs for latissimus dorsi, quadratus lumborum, and multifidus muscles [23]. These findings suggest that needling techniques may be effective on the MTrPs in cer- vical muscles in patients with the FMS. Myofascial release is a therapeutic intervention defined as “a rapidly spreading form of manual therapy aimed at providing pain relief by restoring impaired functions of soft tissues” [31, p.2]. Its effects are provided by the specific behavior of connective tissue sheets, referred to as “fascia”. This tissue represents the main element in the functioning of the musculoskeletal system and it creates the fascial system that connects the whole body, from head to feet. A source of tension in the fascial tissue, provoked by tightening, stiffening, or restricted sliding capacity after micro- trauma or acute injuries, can lead to pain and general dysfunction. Inflammation of the fascial system may lead to peripheral nocicep- tive input, provoking central sensitization in FMS patients. This fascial dysfunction can be attributed to an imbalance of growth hormone production and hypothalamic–pituitary–adrenal axis dys- function. If we assume the relationship among inflammation, fascial system dysfunction, and central sensitization in this population, therapeutic approaches should include interventions that target the fascia [31–33]. The purpose of the current randomized clinical trial was to compare the effectiveness of dry needling versus myofascial release on MTrPs in cervical muscles, quality of life, fatigue, anx- iety and depression in patients with FMS. Methods Design and participants A single-blind randomized controlled trial was conducted on patients with FMS from fibromyalgia associations from AFIAL, AFIEL and FIBROFAMUR (Almer�ıa-Murcia). FMS was diagnosed following criteria for the diagnosis of fibromyalgia from the American College of Rheumatology – ACR (modified 2010) [34]. Chronic widespread musculoskeletal pain symptoms were assessed using the Widespread Pain Index and the Symptoms Severity Scale [34]. Inclusion criteria were, (1) diagnosed with FMS, (2) manifesting chronic widespread musculoskeletal pain symptoms, (3) aged from 18 to 60 years, (4) limitation in activities of daily living due to pain (at least one day in the previous month), and (5) agree- ment to attend evening therapy sessions. Exclusion criteria were, (1) change in the pharmacologic therapy during the period of the study, (2) presence of cardiac, renal or hepatic insufficiency, (3) severe physical disability, (4) comorbid condition (e.g., inflamma- tory disease), (5) fever after infection, (6) hypotension, (7) skin alterations, (8) psychiatric illness, or (9) previous history of surgery. The selection and recruitment was conducted in accordance with the declaration of Helsinki and all subjects signed a written informed consent form prior to their inclusion in the study. This study received ethics approval by the Research Committee of University of Almeria (Almeria, Spain), with Approval Number: UAL-428, Clinical Trials.gov ID: NCT03015662. Randomization Participants who met the inclusion-exclusion criteria were ran- domly assigned to receive either dry needling therapy or myofas- cial release therapy after a baseline examination. Both groups received the intervention by a physical therapist with more than 12 years of experience with FMS patients and chronic pain. All participants received a total of 4 sessions (once a week for four weeks). Concealed allocation (ratio 1:1) was executed by a com- puter-generated randomized table of numbers. This table was per- formed at the beginning of the data collection process by an investigator not involved in the recruitment or treatment phase. The random assignment was included in individual and sequen- tially numbered index cards. These index cards were folded and placed in sealed opaque envelopes. A physiotherapist, blinded to pre- and post-treatment evaluations, opened the envelope and started with the assigned intervention for each participant. Outcome measures Outcome measures were assessed before the first treatment ses- sion (baseline data), and 48 h after the four-week intervention period by the physiotherapist blinded to the treatment allocation of the patients. Evaluations were performed on two successive days to avoid any related fatigue. Clinical and demographic infor- mation including age, sex, height, weight, and education levels were recorded. Algometry was used to evaluate MTrPs in the following pairs of cervical muscles: occipitofrontalis, splenius capitis, sternocleido- mastoid, anterior scalene, middle scalene, posterior scalene, upper 2 A. M. CASTRO S�ANCHEZ ET AL. trapezius, middle trapezius, lower trapezius, supraspinatus, infra- spinatus, and multifidus level C6. The evaluation was performed with a 2-min rest period between each muscle exploration. MTrPs diagnosis was developed following the criteria described by Gerwin et al. [35] and Simons et al. [10]: (1) presence of a palpable taut band within a skeletal muscle, (2) presence of a hyperirritable spot in the taut band, and (3) presence of referred pain in response to MTrPs compression [35]. Measure outcomes were reg- istered three times for each muscle, with a 30-s resting period between each trial. The total scores, used for the main analysis, were the mean of the three trials, increasing the intra-examiner reliability. Inter-rater reliability analyses of this assessment method have shown a substantial agreement among examiners for the MTrPs diagnosis [35]. In addition, patients completed the following self- report measures: The SF-36 quality of life questionnaire assesses eight domains, including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional and mental health. This instrument has a total score ranging from 0 (poorest level of qualityof life) to 100 (highest level of quality of life). The SF-36 questionnaire has been shown to be able to discriminate between subjects with health problems and healthy controls. The Spanish version of the SF-36 showed good levels of reliability and validity. Reliability of SF-36 was high for all subscales from the questionnaire, with Cronbach’s alpha indices ranging from 0.84 to 0.95 [36–38]. The Spanish version of the fibromyalgia impact questionnaire was used to assess the impact of FMS symptoms on the physical and mental health of patients. This questionnaire consists of 10 subscales assessing physical function, number of days feeling good (well-being), work missed, ability to do work, pain, fatigue, rest, stiffness, anxiety, and depression. The scores range from 0 to 100, with higher scores reflecting a more negative impact. This questionnaire has shown a total interclass correlation coefficient of 0.81 [39]. The Pittsburgh Quality of Sleep Questionnaire Index was used to assess the quality of sleep. It comprises of 24 items, where patients respond to 19 of these items, and a person living in the same dwelling (or hospital room) responds to the remaining five. This questionnaire has 7 dimensions: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction. Each dimen- sion is scored from 0 (no problems) to 3 (severe problems), where the total score varies in a range from 0 to 21 points. Psychometric analysis of the Pittsburgh Quality of Sleep Questionnaire Index showed a high reliability with a coefficient of 0.78 [40]. The Visual Analog Scale was used to assess pain intensity and degree of relief experienced by patients, scored from 0 points (no pain) to 10 points (unbearable pain). The test-retest reliability ana- lysis showed a correlation of 0.64 for the visual numeric version in Spanish [41]. Anxiety levels were evaluated using the 40-item State-Trait Anxiety Inventory, which measures anxiety as a stable dimension of personality (trait or tendency to anxiety) and state anxiety. The trait anxiety subscale reports the frequency with which anxiety is experienced. However, the state anxiety subscale indicates the feelings or sensations of anxiety at a specific moment in time (at evaluation time). Factorial analyses identified four factors related to the presence or absence of anxiety on each scale: presence of state anxiety, absence of state anxiety, presence of trait anxiety, and absence of trait anxiety. Cronbach’s alpha for total score of State-Trait Anxiety Inventory was 0.93, showing a high reliability for this inventory [42,43]. The Beck Depression Inventory was used to evaluate a wide spectrum of depressive symptoms by a self-applied 21-item ques- tionnaire. The total questionnaire score ranges from 0 to 63 points. The result is interpreted by the usual classifications as fol- lows: no depression (0–9 points), mild depression (10–18 points), moderate depression (19–29 points) and severe depression (�30 points). Internal consistency was high, with Cronbach’s alpha at 0.87 [44,45]. Fatigue Impact Scale assesses the impact of fatigue. It is a questionnaire-based inventory, which requires patients to rate the perceived functional limitations in the psychosocial, cognitive, and physical domains due to fatigue over the previous month. This questionnaire is scored from 0 (no problem) to 4 (extreme prob- lem), with a maximum score in the three sub-scales of 80, 40, and 40 points, respectively. The total score of impact is 160 points, representing the highest level of perceived fatigue. Internal con- sistency for the Fatigue Impact Scale and its three subscales was high, with Cronbach’s alpha higher than 0.87. Fatigue Impact Scale also showed a good test-retest reliability with coefficients ranging from 0.68 to 0.85 [46,47]. The Hospital Anxiety Depression scale was designed to detect significant anxiety and depression in general medical patients. This scale contains 7 items in each of its two subscales, anxiety and depression. The total score ranges from 0 to 21 points on each subscale, which have shown to provide independent meas- ures of these mood disorders in medical populations. The test- retest reliability of Hospital Anxiety Depression scale showed cor- relation coefficients higher than 0.85. The internal consistency was high, with Cronbach’s alpha at 0.86 for anxiety and 0.86 for depression [48]. Interventions Dry needling therapy Active or latent MTrPs were highlighted in black or red, respect- ively. Active or latent MTrPs were needled in the same position employed by the blinded examiner for diagnosis. All dry needling procedures were performed by the same investigator individually, and the technique used was similar to the Hong method [49,50], using sterile Ener-Qi needles (EQ 1661) for the puncture of MTrPs (trigger points). After cleansing the skin (2% chlorhexidine), the needle (0.25� 25) (diameter� length) was inserted to a depth of 5–15mm depending on the depth of active or latent trigger point. The insertions of the needle in each MTrPs were performed using Hong’s fast-in, fast-out technique until a local twitch response was obtained. Hypoxia was produced by compression (for 15 s) in every active or latent MTrPs needled [50]. All patients received four sessions (once-weekly). This technique was applied to the fol- lowing pairs of muscles, selected according to Simons et al. [10]: occipitofrontalis, splenius capitis, sternocleidomastoid (clavicular branch MTrPs 1, 2, and 3; sternal branch MTrPs 1, 2, 3, and 4), sca- lene (anterior MTrPs 1 and 2; middle MTrP 1; posterior MTrP 1), trapezius (upper MTrPs 1 and 2; middle MTrPs 5, 6, and 7; lower MTrPs 3 and 4), supraspinatus (central point; myotendinous inser- tion; tendon), infraspinatus (upper middle area; upper lateral area; lateral scapular side; middle scapular side), and multifidus (level C6). Myofascial release therapy Patients received a myofascial therapy standardized protocol indi- vidually [32,33,51], following the procedure described in the appendix published by Castro-S�anchez et al. [32] termed as “Description of the Techniques Applied in the Myofascial Therapy DRY NEEDLING AND MYOFASCIAL RELEASE ON FIBROMYALGIA 3 Protocol”. This protocol was performed in the following order: deep fascia release in the temporal region, suboccipital release, compression-decompression of the temporomandibular joint, glo- bal release of cervicodorsal fascia, release of pectoral region, dia- phragm release (transverse slide), and transverse diaphragmatic plane [32,33,51]. Statistical analyses An assessor blinded to the treatment allocation conducted the statistical analyses using SPSS statistical software (SPSS Inc., Chicago, IL, USA), version 22.0. Firstly, the normal distribution of variables was verified by the Kolgomorov-Smirnov test, after a descriptive analysis. The homogeneity of variances was observed using Levene’s test. Linearity was evaluated by bivariate scatter plots of observed residual values against the expected values. Comparisons between groups were conducted among demo- graphic and clinical data at baseline, using the Student t-test for continuous data and the chi-square test for categorical data. The time �groups effects between both groups (dry needling versus myofascial release therapy) and time points (baseline versus post- treatment evaluation for the primary outcome (active and latent myofascial trigger points: number of trigger points) were calcu- lated using repeated measures analysis of variance ANOVA. All analyses followed the intention to treat principle. Changes in vari- able scores within and between groups were measured by means of t-tests for paired or independent samples as appropriate (95% confidence interval). Effect sizes were calculated using Cohen’s d coefficient. An effect size <0.2 reflects a negligible difference, between �0.2 and <0.5 a small difference, between �0.5 and <0.8 a moderate difference,and �0.8 a large difference. p Values <0.05 was considered statistically significant. Sample size calcula- tion was performed by using G�power software (http://www.gpo- wer.hhu.de/en.html). Results Participants In total, 82 FMS patients were recruited for the clinical trial and 64 patients, 58 women and 6 men, aged 27–58 years (mean: 48.71 ± 7 years), met the inclusion criteria. They were randomly assigned to the dry needling group (n¼ 32) or myofascial release group (n¼ 32). The M± SD for demographic characteristics and differences between groups at baseline are shown in Table 1. Both groups had similar characteristics since no significant differ- ence was found when comparing them. A flowchart of the recruit- ment and follow-up of participants is depicted in Figure 1. Changes in pain pressure thresholds: MTrPs algometry Significant time � groups interaction were achieved for the follow- ing pain pressure thresholds in MTrPs: Occipitofrontalis (right: F¼ 14.14, p< 0.001, CI¼ 0.26, 0.99; left: F¼ 4.41, p¼ 0.040, CI¼ 0.14, 1.06), splenius capitis (right: F¼ 4.25, p¼ 0.044, CI¼ 0.12, 0.69; left: F¼ 8.50, p¼ 0.005, CI¼ 0.09, 0.70), anterior scalene 1 (right: F¼ 4.11, p¼ 0.047, CI¼�0.11, 0.15; left: F¼ 4.79, p¼ 0.033, CI¼�0.06, 0.26), anterior scalene 2 (right: F¼ 4.55, p¼ 0.038, CI¼ 0.03, 0.04; left: F¼ 7.09, p¼ 0.010, CI¼ 0.04, 0.43), middle sca- lene (left: F¼ 4.17, p¼ 0.046, CI¼ 0.08, 0.50), upper trapezius 2 (right: F¼ 10.33, p¼ 0.002, CI¼ 0.06, 1.09), lower trapezius 3 (right: F¼ 4.46, p¼ 0.039, CI¼ 0.39, 1.41), middle trapezius 5 (right: F¼ 7.96, p¼ 0.007, CI¼ 0.10, 0.99), middle trapezius 7 (right: F¼ 9.43, p¼ 0.003, CI¼ 0.16, 0.42), myotendinous insertion of supraspinatus (right: F¼ 8.35, p¼ 0.005, CI¼ 0.11, 1.06), upper middle area of the infraspinatus (right: F¼ 6.59, p¼ 0.013, CI¼ 0.074, 0.58). Infraspinatus lateral scapular side (left: F¼ 4.16, p¼ 0.046, CI¼ 0.21, 0.84) and multifidus level C6 (right: F¼ 13.51, p¼ 0.001, CI¼ 0.09, 0.78). Within group analysis demonstrated a significant pre-post-treatment improvement for most MTrPs (at least on one side) in the dry needling group, however, myofascial release group only showed changes over time for sternal sterno- cleidomastoid 2 and 4, anterior scalene 2, central and myotendi- nous insertion of supraspinatus and infraspinatus middle scapular side. Table 2 shows pre-post-intervention values and within and between-group changes scores with associated 95% CI for MTrPs algometry. The effects sizes ranged from small to large for the dry needling group (minimum d¼ 0.22, maximum d¼ 1.13) and from negligible to small for the myofascial release group (minimum d¼ 0.16 maximum d¼ 0.23). Changes in quality of life, impact of FMS symptoms and quality of sleep Regarding quality of life, the ANOVA analysis showed significant time � groups interaction for physical function (F¼ 12.74, p¼ 0.001, CI¼�6.31, 16.65), physical role (F¼ 11.24, p¼ 0.001, CI¼ 8.34, 41.65), body pain (F¼ 30.26, p< 0.001, CI¼ 11.73, 33.93), general health (F¼ 15.83, p< 0.001, CI¼�5.20, 13.03), vitality (F¼ 13.51, p¼ 0.001, CI¼ 0.76, 23.23), social function (F¼ 4.73, p¼ 0.034, CI¼�0.46, 26.63), emotional role (F¼ 8.01, p¼ 0.006, CI¼�13.05, 33.05), mental health subscales (F¼ 4.95, p¼ 0.030, CI¼�1.22, 20.42) and after four week post-treatment. Between-groups analysis showed significant differences at post- treatment evaluation for physical role (t¼ 3.161, p¼ 0.003), body pain (t¼ 4.338, p< 0.001), vitality (t¼ 2.007, p¼ 0.049), and social function (t¼ 2.195, p¼ 0.032). Figure 2 shows between-group dif- ferences for fibromyalgia symptoms. Within group analysis showed a significant improvement from baseline values for all subscales in the dry needling group (p< 0.05). The myofascial release group only experienced pre-post-treatment changes for physical function (t¼�5.043, p¼ 0.009) and body pain (t¼�6.212, p¼ 0.011). The effect sizes for quality of life in the dry needling group were small to large (minimum d¼ 0.44, max- imum d¼ 0.86), and in the myofascial release were negligible/ small (d� 0.20). Regarding the impact on FMS symptoms, similar results were achieved for the Fibromyalgia Impact Questionnaire, showing sig- nificant time �groups interaction for physical impairment Table 1. M± SD and absolute frequency of patients’ characteristics at baseline. Dry needling group N¼32 Myofascial release group N¼ 32 p Age (years) 47.37 ± 4.98 46.79 ± 7.23 0.225 Age range 29–59 26–57 Weight (kg) 69.73 ± 15.32 67.70 ± 15.17 0.527 Height (cm) 158.91 ± 7.63 161.07 ± 6.86 0.100 Sex 0.641 Female 30 28 Male 2 4 Educational level 0.081 No studies 5 3 School level 10 14 Bachelor level 12 13 University level 5 2 Values are expressed as absolute frequency for categorical variables and as means ± standard deviations for continuous variables (N¼ 64). P associated with student t-test for independent samples in continuous variables and chi-square in categorical variables. 4 A. M. CASTRO S�ANCHEZ ET AL. http://www.gpower.hhu.de/en.html http://www.gpower.hhu.de/en.html (F¼ 29.14, p< 0.001, CI¼�2.90, �0.18), number of days feeling good (F¼ 20.69, p< 0.001, CI¼�4.40, �1.87), work missed (F¼ 18.46, p< 0.001, CI¼�4.46, �1.90), ability to do work (F¼ 28.80, p< 0.001, CI¼�3.96, �1.83), pain (F¼ 29.59, p< 0.001, CI¼�3.87, �1.92), fatigue (F¼ 32.01, p< 0.001, CI¼�3.44, �1.48), rested (F¼ 28.54, p< 0.001, CI¼�3.57, �1.62), stiffness (F¼ 31.09, p< 0.001, CI¼�3.52, �1.40), anxiety (F¼ 9.53, p¼ 0.002, CI¼�2.85, -0.34), depression (F¼ 9.17, p¼ 0.004, CI¼�2.12, 0.72) and total score of Fibromyalgia Impact Questionnaire (F¼ 42.91, p< 0.001, CI¼�33.14, 14.27). Between- groups analysis showed significant differences at post-treatment evaluation for physical impairment (t¼�2.359, p¼ 0.021), number of days feeling good (t¼�5.285, p< 0.001), work missed (t¼ 5.278, p< 0.001), ability to do work (t¼�5.882, p<0.001), pain (t¼�6.508, p< 0.001), fatigue (t¼�5.549, p< 0.001), rested (t¼�5.822, p< 0.001), stiffness (t¼�5.062, p< 0.001), anxiety (t¼�2.877, p¼ 0.006), and total score of Fibromyalgia Impact Questionnaire (t¼�5.450, p< 0.001). Figure 3 shows between- group differences for fibromyalgia symptoms. Within group ana- lysis showed significant changes from baseline values for all sub- scales in the dry needling group (p< 0.05). The myofascial release group only experienced pre-post-treatment improvement for num- ber of days feeling good (t¼ 7.289, p¼ 0.001), work missed (t¼ 6.813, p¼ 0.004), ability to do work (t¼ 6.975, p¼ 0.012), pain (t¼ 6.796, p¼ 0.015) and stiffness (t¼ 6.780, p¼ 0.008) subscales. The effects size was large (d¼ 1.67) in the dry needling group for the total score of Fibromyalgia Impact Questionnaire and small in the myofascial release group (d¼ 0.27). Regarding quality of sleep, time � groups interactions were also found for quality of sleep (F¼ 8.07, p¼ 0.006, CI¼�0.98, -0.28), sleep latency (F¼ 9.91, p¼ 0.003, CI¼�0.59, 0.33), daily dysfunc- tion (F¼ 11.96, p¼ 0.001, CI¼�1.05, 0.12) and total score of Pittsburgh Quality of Sleep Questionnaire Index (F¼ 11.96, p¼ 0.001, CI¼�5.54, 0.85). Between-groups analysis showed sig- nificant differences at post-treatment evaluation for quality of sleep (t¼�4.139, p< 0.001), and total score of Pittsburgh Quality of Sleep Questionnaire Index (t¼�3.150, p¼ 0.003). Figure 4 shows between-group differences for fibromyalgia symptoms. Within-group analysis showed only significant changes from base- line values in the dry needling group for these outcomes (p< 0.05). The effects size was moderate in the dry needling group for the total score of PSQ (d¼ 0.45). Changes in anxiety, depression, pain intensity, and fatigue For anxiety, the 2� 2 ANOVA repeated measures demonstrated time � groups interaction for state anxiety (F¼ 8.82, p¼ 0.004, CI¼�0.45, 0.12), trait anxiety (F¼�10.25, p¼ 0.002, CI¼�0.54, 0.14), total state anxiety (F¼ 7.40, p¼ 0.009, CI¼�6.74, 3.249), total trait anxiety (F¼�14.63, p< 0.001, CI¼�9.85, 1.19). However, between-groups analysis showedno significant differences at post-treatment evaluation (p> 0.05). For depression, time � groups interaction was found for Beck Depression Inventory (F¼ 24.360, p< 0.05, CI¼ 19.34, 27.28) and significant differences at post-treatment evaluation were achieved (t¼�2.115, p¼ 0.038). Regarding Hospital Anxiety-Depression Scale, similar Figure 1. Design and flow of participants through the trial following CONSORT 2010 guidelines. DRY NEEDLING AND MYOFASCIAL RELEASE ON FIBROMYALGIA 5 Table 2. Baseline, post-treatment, pre-post-treatment differences and change scores in each group (95% confidence interval) for MTrPs Algometry. Outcome/group Side Baseline One month post-treatment Paired t-test p Within-group score Changes Between-group score Changes Occipitofrontalis (kg/cm2) Dry needling Right 2.23 ± 0.68 2.86 ± 0.79 0.001� �0.63 (�0.88, �0.38) 0.63 (0.26, 0.99) Left 2.41 ± 0.74 2.98 ± 0.89 0.001� �0.57 (�0.83, �0.30) Myofascial Right 2.12 ± 0.56 2.24 ± 0.62 0.078 �0.12 (�0.24, 0.02) 0.61 (0.14, 1.06) Left 2.17 ± 0.60 2.39 ± 0.83 0.120 �0.21 (�0.45, 0.05) Splenius capitis (kg/cm2) Dry needling Right 2.45 ± 0.67 2.88 ± 0.44 0.001� �0.43 (�0.65, �0.21) 0.40 (0.12, 0.69) Left 2.60 ± 0.62 2.91 ± 0.34 0.003� �0.31 (�0.51, �0.11) Myofascial Right 2.32 ± 0.69 2.47 ± 0.63 0.053 �0.16 (�0.32, 0.002) 0.40 (0.09, 0.70) Left 2.48 ± 0.73 2.49 ± 0.74 0.228 �0.03 (�0.07, 0.02) Clavicular sternocleidomastoid 1 (kg/cm2) Dry needling Right 2.25 ± 0.13 2.28 ± 0.13 0.088 �0.03 (�0.05, 0.004) �0.15 (�0.23, �0.06) Left 2.32 ± 0.08 2.33 ± 0.07 0.536 �0.006 (�0.03, 0.01) Myofascial Right 2.43 ± 0.19 2.44 ± 0.20 0.857 �0.004 (�0.02, 0.01) �0.07 (�0.13, �0.02) Left 2.40 ± 0.15 2.42 ± 0.16 0.324 �0.005 (�0.01, 0.001) Clavicular sternocleidomastoid 2 (kg/cm2) Dry needling Right 2.22 ± 0.22 2.28 ± 0.17 0.068 �0.06 (�0.12, 0.004) �0.13 (�0.24, �0.02) Left 2.33 ± 0.07 2.35 ± 0.07 0.023� �0.016 (�0.04, 0.01) Myofascial Right 2.41 ± 0.24 2.42 ± 0.26 0.658 �0.002 (�0.03, 0.02) �0.04 (�0.13, 0.03) Left 2.41 ± 0.17 2.41 ± 0.23 0.891 0.012 (�0.03, 0.06) Clavicular sternocleidomastoid 3 (kg/cm2) Dry needling Right 2.29 ± 0.14 2.31 ± 0.14 0.110 �0.02 (�0.04, 0.004) �0.15 (�0.23, �0.07) Left 2.33 ± 0.08 2.35 ± 0.09 0.202 �0.016 (�0.04, 0.01) Myofascial Right 2.45 ± 0.17 2.47 ± 0.18 0.736 �0.007 (�0.02, 0.16) �0.06 (�0.13, 0.02) Left 2.41 ± 0.18 2.44 ± 0.20 0.063 �0.02 (�0.02, 0.02) Sternal sternocleidomastoid 1 (kg/cm2) Dry needling Right 2.25 ± 0.17 2.27 ± 0.18 0.402 �0.02 (�0.08, �0.03) �0.13 (�0.26, 0.003) Left 2.34 ± 0.14 2.35 ± 0.14 0.264 �0.01 (�0.03, 0.01) Myofascial Right 2.39 ± 0.30 2.41 ± 0.32 0.267 �0.02 (�0.04, 0.02) �0.06 (�0.15, 0.04) Left 2.44 ± 0.19 2.43 ± 0.24 0.785 0.01 (�0.01, 0.07) Sternal sternocleidomastoid 2 (kg/cm2) Dry needling Right 2.18 ± 0.28 2.26 ± 0.23 0.108 �0.07 (�0.17, 0.01) �0.12 (�0.26, 0.03) Left 2.27 ± 0.22 2.41 ± 0.12 0.019� �0.14 (�0.25, �0.02) Myofascial Right 2.32 ± 0.33 2.36 ± 0.34 0.066 �0.04 (�0.11, 0.02) 0.05 (�0.06, 0.17) Left 2.31 ± 0.31 2.37 ± 0.28 0.049� �0.05 (�0.01, 0.001) Sternal sternocleidomastoid 3 (kg/cm2) Experimental Right 2.24 ± 0.24 2.31 ± 0.15 0.141 �0.07 (�0.17, 0.02) �0.08 (�0.20, 0.04) Left 2.32 ± 0.18 2.36 ± 0.12 0.130 �0.04 (�0.09, 0.01) Myofascial Right 2.36 ± 0.32 2.38 ± 0.29 0.344 �0.02 (�0.07, 0.16) 0.03 (�0.06, 0.16) Left 2.33 ± 0.27 2.31 ± 0.25 0.303 0.012 (�0.00, 0.03) Sternal sternocleidomastoid 4 (kg/cm2) Dry needling Right 2.31 ± 0.15 2.30 ± 0.12 0.861 0.003 (�0.35, 0.04) �0.18 (�0.27, 0.08) Left 2.38 ± 0.08 2.40 ± 0.10 0.009� �0.02 (�0.05, �0.01) Myofascial Right 2.48 ± 0.23 2.47 ± 0.23 0.429 0.009 (�0.39, 0.05) �0.06 (�0.13, 0.02) Left 2.43 ± 0.18 2.46 ± 0.20 0.031� �0.02 (�0.05, 0.001) Anterior scalene 1 (kg/cm2) Dry needling Right 2.36 ± 0.31 2.44 ± 0.26 0.083 �0.08 (�0.17, 0.01) 0.02 (�0.11, 0.15) Left 2.48 ± 0.39 2.54 ± 0.38 0.057 �0.06 (�0.12, 0.00) Myofascial Right 2.46 ± 0.20 2.42 ± 0.26 0.321 0.04 (�0.03, 0.11) 0.09 (�0.06, 0.26) Left 2.46 ± 0.22 2.45 ± 0.23 0.326 0.01 (�0.010, 0.03) Anterior scalene 2 (kg/cm2) Dry needling Right 2.18 ± 0.45 2.42 ± 0.35 0.012� �0.23 (�0.41, �0.05) 0.24 (0.03, 0.04) Left 2.43 ± 0.51 2.57 ± 0.37 0.024� �0.14 (�0.26, �0.02) Myofascial Right 2.15 ± 0.44 2.18 ± 0.41 0.541 �0.03 (�0.11, 0.06) 0.23 (0.04, 0.43) Left Left 2.30 ± 0.36 2.34 ± 0.37 0.039� �0.03 (�0.06, �0.001) Middle scalene (kg/cm2) Dry needling Right 2.12 ± 0.50 2.38 ± 0.41 0.016� �0.26 (�0.47, �0.05) 0.11 (�0.12, 0.34) Left 2.35 ± 0.56 2.53 ± 0.39 0.009� �0.18 (�0.31, �0.04) Myofascial Right 2.23 ± 0.52 2.27 ± 0.49 0.619 �0.03 (�0.16, 0.10) 0.29 (0.08, 0.50) Left Left 2.23 ± 0.47 2.24 ± 0.43 0.906 �0.001 (�0.12, 0.10) Posterior scalene (kg/cm2) Dry needling Right 2.84 ± 0.43 2.88 ± 0.49 0.086 �0.03 (�0.07, 0.00) 0.25 (0.08, 0.43) Left 2.84 ± 0.37 2.90 ± 0.40 0.059� �0.06 (�0.12, 0.00) Myofascial Right 2.60 ± 0.19 2.62 ± 0.19 0.109 �0.02 (�0.05, 0.00) 0.23 (0.04, 0.41) Left Left 2.63 ± 0.29 2.67 ± 0.30 0.062 �0.04 (�0.07, 0.00) Upper trapezius 1 (kg/cm2) Dry needling Right 3.33 ± 1.12 3.63 ± 0.88 0.082 �0.30 (�0.65, 0.04) 0.36 (�0.14, 0.87) Left 3.33 ± 1.11 3.53 ± 0.96 0.043� �0.19 (�0.38, �0.006) Myofascial Right 3.23 ± 1.08 3.27 ± 1.06 0.063 �0.004 (�0.08, 0.002) 0.31 (�0.19, 0.82) Left 3.08 ± 1.09 3.22 ± 1.01 0.195 �0.13 (�0.33, 0.07) Upper trapezius 2 (kg/cm2) Dry needling Right 2.32 ± 0.95 3.37 ± 0.90 0.001� �1.05 (�1.45, �0.65) 0.57 (0.06, 1.09) Left 2.61 ± 1.05 3.31 ± 0.94 0.001� �0.70 (�1.06, �033) (continued) 6 A. M. CASTRO S�ANCHEZ ET AL. Table 2. Continued Outcome/group Side Baseline One month post-treatment Paired t-test p Within-group score Changes Between-group score Changes Myofascial Right 2.53 ± 1.06 2.80 ± 1.08 0.089 �0.26 (�0.56, 0.004) 0.78 (0.27, 1.28) Left 2.40 ± 0.95 2.53 ± 0.99 0.316 �0.12 (�0.37, 0.12) Lower trapezius 3 (kg/cm2) Dry needling Right 2.82 ± 1.14 3.35 ± 1.01 0.030� �0.54 (�1.02, �0.05) 0.91 (0.39, 1.41) Left 3.37 ± 1.06 3.49 ± 1.00 0.355 �0.12 (�0.38, 0.14) Myofascial Right 2.49 ± 0.96 2.45 ± 0.94 0.748 0.05 (�0.24, 0.34) 0.63 (0.08, 1.19) Left 2.80 ± 1.12 2.85 ± 1.13 0.490 �0.05 (�0.20, 0.10) Lower trapezius 4 (Kg/cm2) Dry needling Right 3.90 ± 0.70 3.93 ± 0.69 0.009� �0.02 (�0.05, �0.001) 0.32 (�0.08, 0.72) Left 3.72 ± 0.89 3.75 ± 0.82 0.758 �0.03 (�0.22, 0.16) Myofascial Right 3.51 ± 0.94 3.61 ± 0.86 0.165 �0.10 (�0.25, 0.04) �0.00 (�0.38, 0.38) Left 3.75 ± 0.64 3.75 ± 0.65 1.000 � Middle trapezius 5 (kg/cm2) Dry needling Right 3.63 ± 1.08 4.01 ± 0.64 0.020� �0.38 (�0.069, �0.06) 0.54 (0.10, 0.99) Left 3.99 ± 0.62 4.05 ± 0.65 0.656 �0.05 (�0.31, 0.20) Myofascial Right 3.47 ± 1.03 3.87 ± 0.72 0.177 0.11 (�0.05, 0.27) 0.01 (�0.26, 0.29) Left 4.03 ± 0.37 4.04 ± 0.40 0.763 0.006 (�0.05, 0.03) Middle trapezius 6 (Kg/cm2) Dry needling Right 4.23 ± 0.18 4.27 ± 0.18 0.039� �0.03 (�0.06, �0.001) 0.38 (0.09, 0.66) Left 4.06 ± 0.64 4.09 ± 0.60 0.365 �0.03 (�0.09, 0.03) Myofascial Right 3.87 ± 0.72 3.89 ± 0.75 0.415 �0.02 (�0.06, 0.02) 0.04 (�0.23, 0.32) Left 4.07 ± 0.45 4.05 ± 0.47 0.475 0.02 (�0.03, 0.06) Middle trapezius 7 (kg/cm2) Dry needling Right 4.42 ± 0.21 4.49 ± 0.20 0.001� �0.07 (�0.09, �0.04) 0.29 (0.16, 0.42) Left 4.35 ± 0.16 4.34 ± 0.19 0.798 0.01 (�0.07, 0.08) Myofascial Right 4.22 ± 0.27 4.19 ± 0.29 0.348 0.02 (�0.03, 0.08) 0.09 (�0.04, 0.21) Left 4.25 ± 0.27 4.25 ± 0.29 0.882 �0.003 (�0.05, 0.04) Central supraspinatus (kg/cm2) Dry needling Right 3.03 ± 0.93 3.60 ± 0.60 0.001� �0.57 (�0.87, 0.27) 0.49 (0.07, 0.91) Left 3.43 ± 0.80 3.54 ± 0.76 0.291 �0.11 (�0.32, 0.10) Myofascial Right 2.87 ± 1.03 3.11 ± 0.97 0.042� �0.23 (�0.46, �0.01) 0.20 (�0.22, 0.63) Left 3.25 ± 0.93 3.34 ± 0.88 0.133 �0.09 (�0.20, 0.02) Myotendinous insertion of supraspinatus (kg/cm2) Dry needling Right 2.92 ± 1.00 3.65 ± 0.78 0.002� �0.66 (�1.01, �0.25) 0.59 (0.11, 1.06) Left 3.58 ± 0.77 3.88 ± 0.34 0.026� �0.30 (�0.56, �0.04) Myofascial Right 3.02 ± 1.04 2.96 ± 1.04 0.701 0.06 (�0.25, 0.37) 0.91 (0.51, 1.31) Left 2.91 ± 1.00 2.96 ± 1.04 0.596 �0.05 (�0.24, 0.14) Supraspinatus tendon (kg/cm2) Dryneedling Right 3.80 ± 0.60 3.93 ± 0.41 0.288 �0.13 (�0.39, 0.12) 0.10 (�0.15, 0.35) Left 4.01 ± 0.11 4.04 ± 0.12 0.078 �0.03 (�0.07, 0.004) Myofascial Right 3.78 ± 0.59 3.83 ± 0.57 0.007� �0.05 (�0.09, �0.01) 0.10 (�0.06, 0.25) Left 3.87 ± 0.40 3.94 ± 0.41 0.001� �0.07 (�0.11, �0.03) Upper middle area of the infraspinatus (kg/cm2) Dry needling Right 3.39 ± 0.82 3.73 ± 0.48 0.014� �0.34 (�0.61, �0.07) 0.25 (�0.07, 0.58) Left 3.45 ± 0.83 3.61 ± 0.72 0.084 �0.16 (�0.35, 0.02) Myofascial Right 3.47 ± 0.78 3.48 ± 0.76 0.861 �0.003 (�0.04, 0.03) 0.13 (�0.25, 0.42) Left 3.44 ± 0.81 3.48 ± 0.78 0.057 �0.03 (�0.07, 0.001) Upper lateral area of the infraspinatus (kg/cm2) Dry needling Right 3.27 ± 0.93 3.67 ± 0.67 0.039� �0.40 (�0.79, �0.02) 0.34 (�0.06, 0.75) Left 3.75 ± 0.65 3.89 ± 0.37 0.111 �0.13 (�0.30, 0.03) Myofascial Right 3.23 ± 0.88 3.33 ± 0.86 0.134 �0.10 (�0.24, 0.03) 0.48 (0.14, 0.86) Left 3.45 ± 0.84 3.41 ± 0.85 0.591 0.04 (�0.11, 0.19) Infraspinatus lateral scapular side (kg/cm2) Dry needling Right 3.65 ± 0.73 3.82 ± 0.48 0.259 �0.17 (�0.49, 0.13) 0.42 (0.05, 0.80) Left 3.74 ± 0.71 4.01 ± 0.17 0.020� �0.27 (�0.50, �0.05) Myofascial Right 3.32 ± 0.94 3.40 ± 0.90 0.227 �0.08 (�0.21, 0.05) 0.52 (0.21, 0.84) Left 3.44 ± 0.84 3.49 ± 0.68 0.068 �0.04 (�0.09, 0.003) Infraspinatus medial scapular side (kg/cm2) Dry needling Right 3.77 ± 0.68 3.91 ± 0.41 0.049� �0.14 (�0.27, �0.001) 0.10 (�0.18, 0.40) Left 33.98 ± 0.39 4.09 ± 0.13 0.064 �0.11 (�0.24, 0.001) Myofascial Right 3.75 ± 0.65 3.81 ± 0.63 0.040� �0.05 (�0.10, �0.002) 0.26 (0.05, 0.45) Left 3.77 ± 0.68 3.84 ± 0.53 0.252 �0.07 (�0.19, 0.05) Multifidus level C6 (kg/cm2) Dry needling Right 2.62 ± 0.66 3.18 ± 0.51 0.001� �0.56 (�0.83, �0.28) 0.44 (0.09, 0.78) Left 3.12 ± 0.51 3.28 ± 0.40 0.158 �0.15 (�0.37, 0.06) Myofascial Right 2.76 ± 0.75 2.74 ± 0.79 0.163 0.02 (�0.14, 0.18) 0.09 (�0.18, 0.38) Left 3.16 ± 0.65 3.18 ± 0.67 0.763 �0.02 (�0.13, 0.08) �p< 05. Values are expressed as means ± standard deviation for baseline and 1month post-treatment and as mean score change (95% confidence interval) for within- and between-group values. DRY NEEDLING AND MYOFASCIAL RELEASE ON FIBROMYALGIA 7 findings were found for the anxiety subscale (F¼ 11.98, p¼ 0.001, CI¼�5.66, �1.53), depression subscale (F¼ 19.62, p< 0.001, CI¼�4.06, 0.72), total score of Hospital Anxiety Depression Scale (F¼ 20.60, p< 0.001, CI¼�9.51, �1.02). Between-groups analysis only showed significant differences at post-treatment evaluation for the anxiety subscale (t¼�3.247, p¼ 0.002). Regarding pain intensity and fatigue, time �groups interaction was observed for pain intensity (F¼ 29.59, p< 0.001, CI¼�3.87, �1.89), physical fatigue (F¼�21.17, p< 0.001, CI¼�11.08, �3.18), psychosocial fatigue (F¼�24.62, p< 0.001, CI¼�19.91, �2.28), cognitive fatigue (F¼�18.26, p< 0.001, CI¼�11.06, �2.40) and total scores of Fatigue Impact Scale (F¼�25.73, Figure 2. Differences between-group (at 1-month post-treatment) for quality of life. Figure 3. Differences between-group (at 1-month post-treatment) for fibromyalgia symptoms. 8 A. M. CASTRO S�ANCHEZ ET AL. p< 0.001, CI¼�41.19, -8.73). Between-groups analysis showed significant differences at post-treatment evaluation for pain inten- sity (t¼�6.508, p< 0.001), physical fatigue (t¼�3.771, p< 0.001), psychosocial fatigue (t¼�2.712, p¼ 0.09), cognitive fatigue (t¼�3–338, p¼ 0.001) and total scores of Fatigue Impact Scale (t¼�3.279, p¼ 0.002). Figure 5 shows between-group differences for fibromyalgia symptoms. Within-group comparisons showed significant differences between baseline and post-treatment for all these outcomes (anx- iety, depression, pain intensity and fatigue) in the dry needling Figure 4. Differences between-group (at 1-month post-treatment) for quality of sleep. Figure 5. Differences between-group (at 1-month post-treatment) for total anxiety, depression, pain intensity and fatigue. DRY NEEDLING AND MYOFASCIAL RELEASE ON FIBROMYALGIA 9 group; however, the myofascial release group showed no changes over time for these variables, except for pain intensity. The effect sizes in the dry needling group were moderate for state and trait anxiety, total Hospital Anxiety Depression scale (d¼ 0.63, d¼ 0.57, d¼ 0.61, respectively), and large for pain and fatigue (d¼ 1.93, d¼ 1.07, respectively). The effect in the myofascial release group for pain intensity was negligible (d� 0.02). Discussion The main results of the present study have shown that the bene- fits obtained through dry needling seem to be higher than those achieved through myofascial therapy in the short term. The results show that a four-week dry needling therapy significantly reduced the sensitivity to MTrPs pressure as measured by algometry in most of the trigger points evaluated, and improved the quality of life, quality of sleep, anxiety, depression, fatigue and intensity of pain, in comparison with myofascial release therapy; whereas, this type of manual therapy showed significant improvements in intensity of pain and impact of fibromyalgia symptoms. Previous studies had already shown the effectiveness obtained after this therapeutic approach by executing a protocol with a large num- ber of treatment sessions [32,33]. A reduction was found in the number of trigger points after dry needling therapy in a similar manner to a previous study on MTrPs in spinal muscles [22]. Research has also reported that intramuscular anesthetic injection into the upper trapezius muscle and local anesthetic epidural blockade decreased hyperalgesia in FMS [23]. Shah et al. [14] observed that inserting a needle into the tissues and its entry into the trigger point may increase the tissue blood circulation of this part of the muscle. Hence, dry nee- dling seems to produce a desensitizing effect in patients with MTrPs, supporting the present findings related to the differences between groups on MTrPs pain. Regarding intensity of pain, both therapies reduced it. Scientific literature suggests that the therapeutic mechanism of pain relief following dry needling might be associated with per- ipheral and central pathways, including segmental inhibition and biochemical activity by means of endogenous opioids and adren- ergic mediators [15,52–54]. Dry needling stimulation on MTrPs induces short-term segmental antinociceptive effects by a modu- lating effect on hyperalgesia, alleviating symptoms of central hyperexcitability. Inactivation of MTrPs using dry needling and the reduction of referred pain can be the result of desensitizing effects of the treatment [54]. On the other hand, although evi- dence of muscle disease in FMS patients is scarce, researchers agree that these patients may show an intramuscular connective tissue or fascial system dysfunction. In fact, most of the symptoms are manifested at the musculoskeletal level. Hence, myofascial release interventions can normalize the length and the sliding characteristics of myofascial tissues by stretching restricted fascia, releasing pressure from the pain-sensitive structures and returning the mobility to the joints. Effective and readily available protocols of myofascial release interventions could redound in multiple ben- efits to FMS patients [31–33]. A study including 10 myofascial release modalities in FMS patients concluded that this therapeutic approach was effective in reducing pain as measured by pressure algometry and the McGill Pain Questionnaire, as well as improving clinical global impression severity and disease impact compared to a placebo group at post-treatment [31,32]. Specifically, improvements were achieved at the second left rib and left glu- teal muscle after a 20-week weekly intervention and one-year post-intervention follow-up; however, the reduction of pain in our clinical trial was produced in cervical muscles. Another similar study, including a massage-myofascial release therapy in patients with FMS, showed a reduction of sensitivity to pain at MTrPs at the lower cervical and gluteal muscles, aswell as the right greater trochanter just after the intervention and at one-month follow-up, in comparison with a placebo group [31,33]. At the end of the treatment period, both groups differed sig- nificantly in quality of sleep, anxiety, depression and fatigue symp- toms and in the total score for the impact of fibromyalgia symptoms. Ouyang et al. [54], after a needle stimulation on tender points in FMS, showed short-term improvements in the intensity of pain, depression, quality of life, pressure pain threshold, phys- ical symptoms, impact of disease and general health; however, the reasons for an improvement mediated by dry needling stimu- lation in FMS were not totally justified. Dry needling at myofascial trigger spots in rabbit skeletal muscles seems to modulate the biochemical responses associated with pain, inflammation, and hypoxia. This treatment reduces substance P, enhances the sz- endorphin levels in the serum and rabbit skeletal muscles. These effects can be associated with the benefits of acupuncture in decreasing mediators of inflammation such as TNF-a, IL-1, IL-6, and pro-inflammatory cytokines in blood and joints; which con- tribute to reducing allodynia, hyperalgesia, fatigue, and depres- sion, respectively [55]. Dry needling of trigger points can also generate a local twitch response with changes to muscle length and tension through regulation of spontaneous electrical activity and a change in blood flow within the ischemic and hypoxic tis- sues of the trigger points [55]. On the other hand, regarding the effectiveness of myofascial release treatment, two randomized clinical trials have shown improvements in quality of life, anxiety levels, quality of sleep and pain at post-treatment and follow-up periods [24,32]. After three months of intervention, FMS patients improved in painful tender points, McGill Pain Score, physical function and clinical severity. At six months post-intervention, FMS patients receiving myofascial release treatment showed a reduction in the mean number of painful points and pain score, but with improved physical function. At one year post-interven- tion, there were improvements in painful points at the second left rib and left gluteal muscle and affective dimension [32]. The current study has some limitations, including the type of therapeutic groups and lack of follow-up assessments. Firstly, dry needling therapy or myofascial release therapy were applied inde- pendently; nevertheless, physical therapists in the clinical setting usually treat their FMS patients with multi-modal approaches. Future studies should examine the effectiveness of multimodal approaches including dry needling on MTrPs in combination with other accepted interventions. Secondly, a placebo control group was not included and this could be an appropriate comparator. Thirdly, there was no evaluation at a follow-up period after the intervention; however, the current findings may provide relevant preliminary data that could guide future interventions in FMS patients. Conclusion This study has shown that dry needling therapy reduced MTrPs pain in patients with FMS. This dry needling protocol also seems to decrease anxiety, depression and fatigue symptoms, and improve quality of life and sleep in a short term. Dry needling and myofascial release therapy reduced the intensity of pain and the impact of fibromyalgia symptoms after four sessions. Dry nee- dling therapy should be strongly considered as a physiotherapy technique inside the multidisciplinary approach implemented on these patients in the rehabilitation context. 10 A. M. CASTRO S�ANCHEZ ET AL. Acknowledgements The authors acknowledge the collaboration of patients and associ- ations involved in this study. Disclosure statement No potential conflict of interest was reported by the authors. References [1] Branco JC, Bannwarth B, Failde I, et al. Prevalence of fibro- myalgia: a survey in five European countries. Semin Arthritis Rheum. 2010;39:448–453. [2] Montoya P, Pauli P, Batra A, et al. Altered processing of pain-related information in patients with fibromyalgia. Eur J Pain. 2005;9:293–303. [3] Desmeules JA, Cedraschi C, Rapiti E, et al. Neurophysiologic evidence for a central sensitization in patients with fibro- myalgia. Arthritis Rheum. 2003;48:1420–1429. [4] Petzke F, Clauw DJ, Ambrose K, et al. Increased pain sensi- tivity in fibromyalgia: effects of stimulus type and mode of presentation. Pain 2003;105:403–413. [5] Staud R. Is it all central sensitization? Role of peripheral tis- sue nociception in chronic musculoskeletal pain. Curr Rheumatol Rep. 2010;12:448–454. [6] Vierck CJ. Mechanisms underlying development of spatially distributed chronic pain (fibromyalgia). Pain. 2006;124: 242–263. [7] Yarnitsky D. Role of endogenous pain modulation in chronic pain mechanisms and treatment. Pain. 2015;156: S24–S31. [8] Unverzagt C, Berglund K, Thomas JJ. Dry needling for myo- fascial trigger point pain: a clinical commentary. Int J Sports Phys Ther. 2015;10:402–418. [9] Alonso-Blanco C, Fern�andez-de-las-Pe~nas C, Morales- Cabezas M, et al. Multiple active myofascial trigger points reproduce the overall spontaneous pain pattern in women with fibromyalgia and are related to widespread mechan- ical hypersensitivity. Clin J Pain. 2011;27:405–413. [10] Simons DG, Travell J, Simon LS. Myofascial pain and dys- function: the trigger point manual. Baltimore: Williams & Wilkins; 1999. [11] Staud R, Vierck CJ, Robinson ME, et al. Overall fibromyalgia pain is predicted by ratings of local pain and pain-related negative affect-possible role of peripheral tissues. Rheumatology (Oxford). 2006;45:1409–1415. [12] Ge HY. Prevalence of myofascial trigger points in fibromyal- gia: the overlap of two common problems. Curr Pain Headache Rep. 2010;14:339–345. [13] Lucas KR, Polus BI, Rich PA. Latent myofascial trigger points: their effect on muscle activation and movement efficacy. J Body Mov Ther. 2004;8:160–166. [14] Shah JP. Integrating dry needling with new concepts of myofascial pain, muscle physiology, and sensitization. In: Audette JF, Bailey A, editors. Integrative pain medicine. Totowa: Human Press; 2008. p. 107–121. [15] Srbely JZ, Dickey JP, Lee D, et al. Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects. J Rehabil Med. 2010;42:463–468. [16] Mung�ıa-Izquierdo DI, Legaz-Arrese AL. Determinants of sleep quality in middle-aged women with fibromyalgia syn- drome. J Sleep Res. 2012;21:73–79. [17] Sener U, Ucok K, Ulasli AM, et al. Evaluation of health- related physical fitness parameters and association analysis with depression, anxiety, and quality of life in patients with fibromyalgia. Int J Rheum Dis. 2016;19:763–772. [18] Luciano JV, Forero CG, Cerd�a-Lafont M, et al. Functional sta- tus, quality of life, and costs associated with fibromyalgia subgroups: a latent profile analysis. Clin J Pain. 2016;32:829–840. [19] Hsieh YL, Kao MJ, Kuan TS, et al. Dry needling to a key myofascial trigger point may reduce the irritability of satel- lite MTrPs. Am J Phys Med Rehabil. 2007;86:397–403. [20] Affaitati G, Costantini R, Fabrizio A, et al. Effects of treat- ment of peripheral pain generators in fibromyalgia patients. Eur J Pain. 2011;15:61–69. [21] Fern�andez-Carnero J, La Touche R, Ortega-Santiago R, et al. Short-term effects of dry needling of active myofascial trig- ger points in the masseter muscle in patients with tem- poromandibular disorders. J Orofac Pain. 2010;24:106–112. [22] Tough EA, White AR, Cummings TM, et al. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of rando- mised controlled trials. Eur J Pain. 2009;13:3–10. [23] Cummings TM, White AR. Needling therapies in the man- agement of myofascial trigger point pain: a systematic review. Arch Phys Med Rehabil. 2001;82:986–992. [24] Gattie E, Cleland JA, Snodgrass S. The effectiveness of trig- ger point dry needling for musculoskeletal conditionsby physical therapists: a systematic review and meta-analysis. J Orthop Sports Phys Ther. 2017;47:133–149. [25] Tekin L, Akarsu S, Durmuş O, et al. The effect of dry nee- dling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013;32:309–315. [26] Itoh K, Katsumi Y, Kitakoji H. Trigger point acupuncture treatment of chronic low back pain in elderly patients-a blinded RCT. Acupunct Med. 2004;22:170–177. [27] Ceccherelli F, Rigoni MT, Gagliardi G, et al. Comparison of superficial and deep acupuncture in the treatment of lum- bar myofascial pain: a double-blind randomized controlled study. Clin J Pain. 2002;18:149–153. [28] Venâncio RA, Alencar FG, Zamperini C. Different substances and dry-needling injections in patients with myofascial pain and headaches. Cranio. 2008;26:96–103. [29] Barbagli P, Bollettin R, Ceccherelli F. Acupuncture (dry nee- dle) versus neural therapy (local anesthesia) in the treat- ment of benign back pain. Immediate and long-term results. Minerva Med. 2003;94:17–25. [30] Sterling M, Valentin S, Vicenzino B, et al. Dry needling and exercise for chronic whiplash – a randomised controlled trial. BMC Musculoskelet Disord. 2009;10:160. [31] Laimi K, M€akil€a A, B€arlund E, et al. Effectiveness of myofas- cial release in treatment of chronic musculoskeletal pain: a systematic review. Clin Rehabil. 2018;32:440–450. [32] Castro-S�anchez AM, Matar�an-Pe~narrocha GA, Arroyo- Morales M, et al. Effects of myofascial release techniques on pain, physical function, and postural stability in patients with fibromyalgia: a randomized controlled trial. Clin Rehabil. 2011;25:800–813. [33] Castro-S�anchez AM, Matar�an-Pe~narrocha GA, Granero- Molina J, et al. Benefits of massage-myofascial release ther- apy on pain, anxiety, quality of sleep, depression, and qual- ity of life in patients with Fibromialgia. Evid Based Complement Alternat Med. 2011;2011:561753. DRY NEEDLING AND MYOFASCIAL RELEASE ON FIBROMYALGIA 11 [34] Bennett RM, Friend R, Marcus D, et al. Criteria for the diag- nosis of fibromyalgia: validation of the modified 2010 pre- liminary American College of Rheumatology criteria and the development of alternative criteria. Arthritis Care Res (Hoboken). 2014;66:1364–1373. [35] Gerwin RD, Shannon S, Hong CZ, et al. Interrater reliability in myofascial trigger point examination. Pain. 1997;69:65–73. [36] Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483. [37] Ware JE, Snow KK, Kosinski M, et al. SF-36 health survey: manual and interpretation guide. Boston (MA): New England Medical Center, The Health Institute; 1993. [38] L�opez-Garc�ıa E, Banegas JR, Graciani P�erez-Regadera A, et al. Valores de referencia de la versi�on espa~nola del Cuestionario de Salud SF-36 en poblaci�on adulta de m�as de 60 a~nos [Population-based reference values for the Spanish version of the SF-36 health survey in the elderly]. Med Clin (Barc). 2003;120:568–573. [39] Monterde S, Salvat I, Montull S, et al. Validacion de la ver- sion espa~nola del Fibromyalgia Impact Questionnaire [Validation of Spanish version of the Fibromyalgia impact questionnaire]. Rev Esp Reumatol. 2004;31:507–513. [40] Jim�enez-Genchi A, Monteverde-Maldonado E, Nenclares- Portocarrero A, et al. Confiabilidad y an�alisis factorial de la versi�on en espa~nol del �ındice de calidad de sue~no de Pittsburgh en pacientes psiqui�atricos [Reliability and factor- ial analysis of the Spanish version of the Pittsburg sleep quality index among psychiatric patients]. Gac Med Mex. 2008;144:491–496. [41] Gonz�alez VM, Stewart A, Ritter PL, et al. Translation and val- idation of arthritis outcome measures into Spanish. Arthritis Rheum. 1995;38:1429–1446. [42] Spielberger CD. Cuestionario de Ansiedad Estado-Rasgo [State-trait anxiety inventory questionnaire]. Madrid: TEA; 2007. [43] Fonseca-Pedrero E, Paino M, Sierra-Baigrie S, et al. Propiedades psicom�etricas del” Cuestionario de ansiedad estado-rasgo”(STAI) en universitarios. Psicol Conductual. 2012;20:547. [44] Lasa L, Ayuso-Mateos JL, V�azquez-Barquero JL, et al. The use of the Beck Depression Inventory to screen for depres- sion in the general population: a preliminary analysis. J Affect Disord. 2000;57:261–265. [45] Sanz J, Perdig�on A, V�azquez C. The Spanish adaptation of Beck’s Depression Inventory-II (BDI-II): 2. Psychometric prop- erties in the general population. Clin Salud. 2003;14:249–280. [46] Fisk JD, Ritvo PG, Ross L, et al. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994;18:S79–S83. [47] Mathiowetz V. Test–retest reliability and convergent validity of the fatigue impact scale for persons with multiple scler- osis. Am J Occup Ther. 2003;57:389–395. [48] Quintana JM, Padierna A, Esteban C, et al. Evaluation of the psychometric characteristics of the Spanish version of the hospital anxiety and depression scale. Acta Psychiatr Scand. 2003;107:216–221. [49] Hong CZ. Lidocaine injection versus dry needling to myo- fascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994;73:256–263. [50] Castro-S�anchez AM, Garc�ıa-Lopez H, Matar�an-Penarrocha GA, et al. Effects of dry needling on spinal mobility and trigger points in patients with Fibromyalgia syndrome. Pain Physician. 2017;20:37–52. [51] Pilat A. Terapias Miofasciales [Myofascial therapies: myofas- cial induction]. Madrid: McGraw-Hill; 2003. [52] Niddam DM, Chan RC, Lee SH, et al. Central modulation of pain evoked from myofascial trigger point. Clin J Pain. 2007;23:440–448. [53] Casanueva B, Rivas P, Rodero B, et al. Short-term improve- ment following dry needle stimulation of tender points in fibromyalgia. Rheumatol Int. 2014;34:861–866. [54] Ouyang BS, Che JL, Gao J, et al. Effects of electroacupunc- ture and simple acupuncture on changes of IL-1, IL-4, IL-6 and IL-10 in peripheral blood and joint fluid in patients with rheumatoid arthritis. Zhongguo Zhen Jiu. 2010;30: 840–844. [55] Hsieh YL, Chou LW, Joe YS, et al. Spinal cord mechanism involving the remote effects of dry needling on the irritabil- ity of myofascial trigger spots in rabbit skeletal muscle. Arch Phys Med Rehabil. 2011;92:1098–1105. 12 A. M. CASTRO S�ANCHEZ ET AL. Abstract Introduction Methods Design and participants Randomization Outcome measures Interventions Dry needling therapy Myofascial release therapy Statistical analyses Results Participants Changes in pain pressure thresholds: MTrPs algometry Changes in quality of life, impact of FMS symptoms and quality of sleep Changes in anxiety, depression, pain intensity, and fatigue Discussion Conclusion Acknowledgements Disclosure statement References
Compartilhar