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https://doi.org/10.1177/0964528419882941 Acupuncture in Medicine 1 –8 DOI: 10.1177/0964528419882941 © The Author(s) 2020 Article reuse guidelines: sagepub.com/journals-permissions journals.sagepub.com/home/aim Acupuncture in Medicine, 00(0) acupuncture IN MEDICINE Post-needling soreness and trigger point dry needling for hemiplegic shoulder pain following stroke Ana Mendigutía-Gómez1, María T Quintana-García1, Miriam Martín-Sevilla1, Diego de Lorenzo-Barrientos2, Jorge Rodríguez-Jiménez3,4, César Fernández-de-las-Peñas3,4,5 and José L Arias-Buría3,4 Abstract Objectives: To determine the presence of post-needling induced pain in subjects who had suffered a stroke and received trigger point (TrP) dry needling (DN), and to investigate the effects of including TrP-DN into a rehabilitation program for shoulder pain in this population. Methods: A randomized clinical trial was conducted. Sixteen patients who had suffered a stroke and presented with shoulder pain were randomly assigned to receive rehabilitation alone or rehabilitation combined with DN. Both groups received a neurorehabilitation session including modulatory interventions targeting the central nervous system. Patients in the DN group also received a single session of DN over active TrPs in the shoulder musculature. A numerical pain rating scale (NPRS, 0–10) was used to asses post-needling induced pain at 1 min, 24 h, and 72 h after needling. Shoulder pain (NPRS, 0–10) was assessed at baseline, and 3 and 7 days after DN in both groups. Results: Five (62%) patients receiving TrP-DN reported post-needling induced pain. Post hoc analysis found that post- needling induced pain decreased significantly at 24 and 72 h (both p < 0.001) after DN. Patients receiving TrP-DN plus rehabilitation exhibited greater decreases in shoulder pain intensity at 3 days (Δ = –4.2, 95% confidence interval (CI) = –5.8 to −2.6) and 7 days (Δ = –4.3, 95% CI = –5.9 to −2.7) after the intervention compared with those receiving rehabilitation alone (all p < 0.001). Conclusion: This trial found that 50% of stroke patients receiving DN experienced post-needling induced pain, a side effect that almost disappeared 72 h after the intervention without any additional therapeutic action. In addition, the inclu- sion of TrP-DN into a rehabilitation session was effective at decreasing shoulder pain in these patients. Keywords dry needling, myofascial trigger point, rehabilitation, shoulder pain, stroke Accepted: 21 September 2019 1 Department of Physical Therapy-Rehabilitation, Hospital Beata María Ana, Madrid, Spain 2 Instituto Nacional de Estadística, Madrid, Spain 3 Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain 4 Cátedra de Investigación y Docencia en Fisioterapia: Terapia Manual y Punción Seca, Universidad Rey Juan Carlos, Alcorcón, Spain 5 Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Alcorcón, Spain 882941 AIM Acupuncture in MedicineMendigutía-Gómez et al. Original paper Corresponding author: César Fernández de las Peñas, Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Avenida de Atenas s/n, 28922 Alcorcón, Madrid, Spain. Email: cesar.fernandez@urjc.es https://uk.sagepub.com/en-gb/journals-permissions journals.sagepub.com/home/aim mailto:cesar.fernandez@urjc.es http://crossmark.crossref.org/dialog/?doi=10.1177%2F0964528419882941&domain=pdf&date_stamp=2020-02-03 2 Acupuncture in Medicine Acupuncture in Medicine, 00(0) Introduction Stroke is one of the major causes of permanent disability with an annual incidence ranging between 1.18% and 1.44% per year.1,2 Although several advances have dropped stroke down to the fourth leading cause of death world- wide,3 it represents a condition causing physical disability in up to 50% of sufferers.4 Stroke-associated disability is mainly related to the pres- ence of spasticity and post-stroke pain. Post-stroke pain includes several painful conditions including central post- stroke pain, painful shoulder, spinal pain, complex regional pain syndrome and spasticity-related pain. It seems that hemiplegic shoulder pain is probably one of the most com- mon forms of post-stroke pain. In fact, hemiplegic shoulder pain has recently been associated with the burden of stroke.5 The prevalence of hemiplegic shoulder pain is 30%,6 although this rate has decreased in recent decades.7 A musculoskeletal origin of post-stroke shoulder pain is more likely than other causes, for example, spasticity- related pain, in the early years after the event.8 Therefore, identification of a potential musculoskeletal source for hemiplegic shoulder pain may be important. Since subjects with hemiplegic shoulder pain usually exhibit not only pain symptoms in the shoulder but also pain referral to the elbow and hand, it is possible that myofascial trigger points (TrPs) can play a potential role in some stroke patients.9 There is preliminary evidence suggesting a role of myofascial pain in post-stroke pain.10 De Oliveira et al.10 found that 67.5% of individuals with post-stroke pain exhibited active TrPs, with the trapezius, supraspinatus, splenius capitis, infraspi- natus and paraspinal muscles being most commonly affected. Therefore, it is possible that treatment of active TrPs in the shoulder muscles could be effective for the management of hemiplegic shoulder pain. Dry needling (DN) is a common intervention used for the management of TrPs in non-neurological conditions.11 In fact, there has been an increasing interest in the applica- tion of DN to treat muscle spasticity;12 however, current evidence is mainly based on case reports.13–15 The only cross-over trial investigating the effects of DN on muscle spasticity in the upper extremity found that the inclusion of DN into a multimodal rehabilitation program was effective at improving pressure pain sensitivity and range of motion at the shoulder, but not muscle spasticity, in people who had experienced a stroke.16 Nevertheless, there is no mention of shoulder pain in previous papers. An old study reported that the inclusion of a needling intervention into an early reha- bilitation program produced better outcomes in patients with hemiparetic shoulder pain; however, this study used an acupuncture approach, not a TrP-DN approach.11 Similarly, a recent systematic review also observed that most studies investigating the effects of needling therapies for shoulder pain in stroke survivors used an acupuncture approach.17 A common minor adverse event observed after the appli- cation of DN is the presence of post-needling induced pain or soreness.18 Post-needling induced pain or soreness is thought to be a consequence of the neuromuscular damage generated by repetitive needle insertions into the TrP area and several studies have documented this phenomenon in musculoskeletal pain conditions.19 Since post-needling soreness can be associated with a possible reluctance to receive further needling therapy and a reduction in treat- ment adherence for some patients, it is important to investi- gate its evolution in patients with neurological conditions. To the best of the authors’ knowledge, no study has previ- ously investigated the presence of post-needling induced pain or soreness and the effects of TrP-DN on shoulder pain symptoms in patients who had suffered a stroke. Therefore, the aims of this clinical trial were: (1) to investigate the presence of post-needling induced pain in subjects who had suffered a stroke receiving TrP needling in the shoulder area; and (2) to investigate effects on shoul- der pain intensity of including a TrP-DN session into a rehabilitation program consisting of modulatory interven- tions targeting the central nervous system following stroke. We hypothesized that all subjects receiving DN would exhibit post-needling induced pain, as this has previously been observed inmusculoskeletal pain, but for no longer than 72 h without the application of any post-needling inter- vention. In addition, we also hypothesized that subjects receiving DN plus rehabilitation would exhibit a greater improvement in the intensity of shoulder pain than those receiving only rehabilitation. Methods Design A randomized, controlled, clinical trial was conducted. The study was registered prospectively at ClinicalTrials.gov (ref. NCT03703193) and conducted in accordance with the Helsinki Declaration, and the study protocol was approved by the human research committee of the Universidad Rey Juan Carlos, Spain (ref. URJC 1512201600817). All par- ticipants signed informed consent before their participation in the study. Participants Consecutive subjects who had experienced a stroke were screened according to the eligibility criteria from October to December 2018. Participants were recruited from Hospital Beata María Ana, Madrid (Spain). To be included, partici- pants needed to have met the following criteria: (1) have experienced a first-ever unilateral stroke; (2) demonstrate hemiplegia resulting from the stroke; (3) be aged between 30 and 60 years; (4) present hypertonicity in the upper extremity; (5) present pain symptoms in the hemiplegic Mendigutía-Gómez et al. 3 Acupuncture in Medicine, 00(0) shoulder; and (6) exhibit active TrPs in the shoulder mus- cles, for which pain referral reproduced the symptoms. Participants were excluded if they had: (1) experienced a recurrent stroke; (2) an absence of activeTrPs in the shoul- der muscles reproducing shoulder symptoms; (3) undergone previous treatments with nerve blocks or motor point injec- tions with neurolytic agents for spasticity at any time; (4) received previous treatment with botulinum toxin-A in the 6 months prior to the trial; (5) severe cognitive deficits; (6) other neurologic diseases; (7) other medical conditions, for example, heart conditions, unstable hypertension, or frac- ture; (8) a fear of needles; or (9) any contraindication to DN, for example, anticoagulant use, infections, bleeding, or psychosis. All participants needed to exhibit at least one active TrP in the shoulder musculature reproducing their shoulder pain symptoms. TrP diagnosis was performed by a clinician with 15 years of experience in TrP treatment in subjects who had experienced a stroke and following the criteria described by Simons et al.20 and confirmed in a recent Delphi study:21 (1) presence of a painful spot in a palpable taut band of a skel- etal muscle; (2) local twitch response elicited by snapping palpation of the taut band; and (3) referred pain in response to compression. To be considered active, the pain referral elicited by the TrP needed to reproduce any symptom expe- rienced by the subject in the hemiplegic shoulder and the subject needed to recognize the symptoms as a familiar experience. The muscles included in manual examination were the upper trapezius, pectoralis major, subscapularis, and infraspinatus. All these muscles are accessible to man- ual palpation and treatment, and the referred pain elicited by their TrPs spreads to the shoulder or upper extremity.20 Interventions Participants were randomly assigned to a DN group or a comparative control group. Concealed allocation was con- ducted using a computer-generated random number table created by an external statistician. All participants received a single session of a rehabilita- tion program including modulatory interventions for spas- ticity and pain control by a clinician with more than 20 years of experience in the management of stroke patients. Since there is no consensus on which rehabilitation approach is most effective for individuals who had experienced a stroke,22 different approaches (unilateral arm training, Bobath therapy, strength training, repetitive task training) have been proposed.23 Therefore, subjects received a single session of 45 min duration including unilateral arm training focusing on decreased muscle tone, passive positioning of the shoulder girdle, and repetitive task training exercises.16 Patients assigned to the DN group also received a single TrP-DN session over active TrPs by a physical therapist with 15 years of experience with this procedure. Once an active TrP was located, the skin was properly cleaned with alcohol. Patients received TrP-DN using disposable stainless steel 0.30 mm × 40 mm needles (Agupunt©, Barcelona, Spain) that were inserted into the skin over the TrP area and advanced into the muscle using the “fast-in and fast-out” technique24 until a first local twitch response was obtained. The depth of needle insertion ranged from 10 to 15 mm depending on the muscle thickness of the targeted muscle: upper trapezius (Figure 1a), infraspinatus (Figure 1c), sub- scapularis (Figure 1c), or pectoralis mayor (Figure 1d). Once the first local twitch response was obtained, the needle was moved up and down (3–5 mm vertical motions, no rotations) for 60 s until no more local twitch responses were elicited. Upon removal of the needle, the area was compressed firmly with a cotton bud for approximately 1 min. Outcome measures The primary outcome included the intensity of post-nee- dling induced pain and was assessed with an 11-point numerical pain rating scale (NPRS; 0 = no pain; 10 = maxi- mum pain).25 It was defined as tenderness or pain perceived around the TrP area receiving the needling procedure. Post- needling induced pain was assessed at 1 min, 24 h, and 72 h after DN. Secondary outcomes including the intensity of shoul- der pain and the presence of active TrPs were assessed before, and 3 and 7 days after the intervention. A separate 11-point NPRS (0–10) was used to assess the mean level of shoulder pain at rest. There is no minimal clinically important difference (MCID) reported for shoulder pain in people who have experienced a stroke. Mintken et al.26 reported that the MCID for the NPRS in individuals with shoulder pain is 1.1 points; therefore, we used this score in our study. Participants were asked to differentiate between their shoulder pain symptoms and TrP-DN- induced pain. Participants were also manually examined for the pres- ence of active TrPs in the same muscles as at baseline, that is, upper trapezius, pectoralis major, subscapularis, and infraspinatus, by an assessor with 10 years of experience in the management of patients who had suffered a stroke who was blinded to each subject’s allocation. Statistical analysis Data were analyzed with SPSS version 22.0 (SPSS Inc., Chicago, IL, USA). Means, standard deviations (SDs) or 95% confidence intervals (CIs) were calculated. The Kolmogorov–Smirnov test revealed a non-normal distribu- tion of data; therefore, non-parametric tests were used in the main analysis. The non-parametric Mann–Whitney U test was used to examine for baseline differences between groups. For the main outcome, the non-parametric Friedman test with time (1 min, 24 h, and 72 h after intervention) as the main within-subjects factor was used to assess the 4 Acupuncture in Medicine Acupuncture in Medicine, 00(0) evolution of post-needling induced pain in the DN group. A second non-parametric Friedman test with time (baseline, 3 and 7 days after intervention) as the main within-subjects and group (DN, comparative control) as the between- subjects factor was used to determine the effects of the interventions on shoulder pain intensity. Finally, a mixed chi-square test (McNemar–Bowker test) was applied to investigate the changes in the distribution of active TrPs between groups at baseline, and 3 and 7 days post-interven- tion. The statistical analysis was conducted using a 95% CI and p ⩽ 0.05 was considered statistically significant. Consistent with the intention-to-treat principle, data from each subject were analyzed within the group to which the subject was assigned. Results Fifty patientswho had experienced a stroke were screened for eligibility criteria. Sixteen (mean ± SD age 47 ± 8 years; 62% female) satisfied all the eligibility criteria, agreed to participate, and were included in the study. The reasons for ineligibility can be found in Figure 2, which provides a flow diagram of patient recruitment. Nine patients (56%) had the left side affected, whereas the remaining seven (44%) had the right side affected. The mean time from the stroke event was 9.0 ± 5.0 months. The baseline characteristics of both groups were similar for all variables (Table 1). Post-needling induced pain Five (62%) of the patients receiving DN reported post- needling induced pain. The Friedman test revealed a sig- nificant effect of time for the evolution of post-needling induced pain (p = 0.007). Post hoc analysis revealed that post-needling induced pain decreased significantly from baseline (mean ± SD = 5.4 ± 2.6) to 24 h (mean ± SD = 2.0 ± 1.5) and 72 h (mean ± SD = 0.5 ± 1.0; both, p < 0.001) after DN (Figure 3a). Changes in shoulder pain The Friedman test for repeated measures found a signifi- cant group × time interaction for shoulder pain intensity (p < 0.001). Patients receiving TrP-DN plus the rehabilita- tion program exhibited greater decreases in shoulder pain intensity at 3 (Δ = –4.2, 95% CI = –5.8 to −2.6) and 7 (Δ = –4.3, 95% CI = –5.9 to −2.7) days after the interven- tion, compared to those receiving the rehabilitation treat- ment session alone (Table 2, Figure 3b). Distribution of active TrPs The distribution of active TrPs in the shoulder muscles was similar (all p > 0.5) in both groups before the interventions (Table 1). All active TrPs in the DN group underwent DN. After the needling session, only two patients exhibited Figure 1. Photographs of dry needling being applied over active trigger points within the upper trapezius (a), infraspinatus (b), subscapularis (c) and pectoralis major (d) muscles. Mendigutía-Gómez et al. 5 Acupuncture in Medicine, 00(0) active TrPs in the muscles within the DN group, whereas no changes were observed within the comparative control group (p < 0.001). Discussion This study demonstrated that application of TrP-DN pro- voked post-needling induced pain in 50% of patients who had experienced a stroke and received DN, but this sore- ness disappeared 72 h after the intervention without any additional therapeutic action. In addition, the inclusion of TrP-DN into a rehabilitation session was effective at decreasing shoulder pain intensity in this population. Previous studies have found that the application of acu- puncture is effective at reducing pain symptoms in the shoulder among people who had experience a stroke.17,27 To our knowledge, this trial is the first to use a TrP-DN approach for the management of hemiplegic shoulder pain. Our results showed that application of a single session of DN of the active TrPs reproducing the shoulder pain symp- toms was effective at reducing the intensity of shoulder pain at a 1 week follow-up time point. The mechanisms underlying the observed changes in shoulder pain after the application of DN are unclear, but some hypotheses are proposed.28 It seems that DN exerts several mechanical effects on the TrP and the central nervous system, which may potentially initiate a cascade of neurophysiological mechanisms leading to anti-nociceptive effects. In fact, TrP-DN may reduce peripheral and central sensitization by removing the source of peripheral nociception (i.e. the TrP), by modulating spinal dorsal horn activity and by acti- vating central inhibitory pain pathways.29 These effects could explain the observed changes in the intensity of shoulder pain. Nevertheless, it is important to consider that other factors may also be involved in hemiplegic shoulder pain at the same time as the active TrPs. An important finding of this study was the presence of post-needling induced pain in just 50% of the patients who had experienced a stroke receiving the TrP-DN. This was an unexpected finding since previous studies conducted in people with musculoskeletal pain observed that all subjects receiving TrP-DN reported post-needling induced pain.19 Similar to previous studies, post-needling induced pain almost disappeared 72 h after the TrP needling procedure without any post-needling intervention, supporting the con- cept that post-needling induced pain could be a natural response, related to tissue healing, after the application of a needling intervention. To our knowledge, this study is the first to describe the presence of post-needling induced pain in patients with a neurological condition. Figure 2. Flow diagram of patients throughout the course of the study. 6 Acupuncture in Medicine Acupuncture in Medicine, 00(0) Figure 3. (a) Evolution of post-needling induced pain within the dry needling group and (b) evolution of shoulder pain intensity by treatment group. Data are expressed as mean and SEM. **Significant differences between groups (Friedman test, p < 0.001). Ta bl e 1. D em og ra ph ic a nd c lin ic al c ha ra ct er is tic s of b ot h gr ou ps a t ba se lin e. C om pa ra tiv e co nt ro l g ro up ( n = 8 ) D ry n ee dl in g gr ou p (n = 8 ) A ge ( ye ar s) 47 ± 7 48 ± 6 G en de r (m al e/ fe m al e) 3/ 5 3/ 5 T im e si nc e st ro ke ( m on th s) 8. 7 ± 4 .0 9. 1 ± 3 .5 A ffe ct ed s id e (le ft /r ig ht ) 3/ 5 4/ 4 Sh ou ld er p ai n (N PR S, 0 –1 0) 7. 1 ± 1 .3 7. 0 ± 1 .2 U pp er tr ap ez iu s Pe ct or al is m aj or Su bs ca pu la ri s In fr as pi na tu s U pp er tr ap ez iu s Pe ct or al is m aj or Su bs ca pu la ri s In fr as pi na tu s A ct iv e tr ig ge r po in ts ( n, % ) 5 (6 3% ) 3 (3 8% ) 3 (3 8% ) 6 (7 5% ) 6 (7 5% ) 2 (2 5% ) 3 (3 8% ) 7 (8 8% ) N PR S: n um er ic al p ai n ra tin g sc al e. D at a ar e ex pr es se d as m ea n ± st an da rd d ev ia tio n ex ce pt fo r ge nd er , a ffe ct ed s id e an d nu m be r of a ct iv e tr ig ge r po in ts . Although the results of our trial are promising, potential limitations should be recognized. First, the sample size was small. This may be related to the inclusion and exclusion criteria, since patients needed to have hemiplegic shoulder pain related to active TrPs. In addition, since no previous study has investigated the presence of post-needling induced pain, a robust sample size calculation could not be performed. Second, as we only collected short-term out- comes, we do not know if the observed changes lasted longer than 1 week. This is particularly relevant for stroke survivors since they are chronic patients. The fact that sig- nificant changes were observed at 1 week follow-up sup- ports future research in this area. Furthermore, only self-reported outcomes of pain intensity were collected. It would be interesting to determine changes in other out- comes, for example, pressure pain thresholds, after applica- tion of TrP-DN in patients with stroke. Third, we cannot determine the isolated effects of TrP-DN since it was applied integrated within a multimodal treatment session. Nevertheless, this represents a pragmatic clinical approach since people with hemiplegic shoulder pain are not treated Mendigutía-Gómez et al. 7 Acupuncture in Medicine, 00(0) with just one technique. Fourth, we only applied a single DN session and the same clinician applied the intervention to all subjects within the DN group, which minimized het- erogeneity but decreases the overall generalizability of the results. Future trials should include an increased number of treatment sessions, with a greater number of clinicians, larger ample size, and longer follow-up periods. In conclusion, this study found that the application ofDN in patients who had suffered a stroke provoked post-nee- dling induced pain in 50% of them, but soreness almost dis- appeared 72 h after the intervention without any additional therapeutic action. Furthermore, the inclusion of a single session of TrP-DN into a multimodal rehabilitation session was effective at decreasing shoulder pain intensity in this population. Future studies with larger sample sizes and long-term periods of follow-up are needed to further con- firm these results. Contributors All authors contributed to the study concept and design. CF-d-l-P and JLA-B performed the main statistical analysis. AM-G, MTQ- G, and MM-S contributed to the literature review and interpreta- tion of data. CF-d-l-P and JLA-B contributed to drafting of the report. DdL-B, JR-J, and JLA-B provided administrative, techni- cal and material support. CF-d-l-P and JLA-B supervised the study. All authors revised the text for intellectual content and have read and approved the final version of the manuscript accepted for publication. Declaration of conflicting interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The authors received no financial support for the research, author- ship, and/or publication of this article. ORCID iDs César Fernández-de-las-Peñas https://orcid.org/0000-0003 -3772-9690 José L Arias-Buría https://orcid.org/0000-0001-8548-4427 References 1.Hilmarsson A, Kjartansson O and Olafsson E. Incidence of first stroke: a population study in Iceland. Stroke 2013; 44(6): 1714–1716. 2. Diaz-Guzman J, Egido JA, Gabriel-Sanchez R, et al. Stroke and tran- sient ischemic attack incidence rate in Spain: the IBERICTUS study. Cerebrovasc Dis 2012; 34(4): 272–281. 3. Burke JF, Lisabeth LD, Brown DL, et al. 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