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INTRODUCTION Low back pain Low back pain (LBP) is a very common condition which poses significant problems to the health service. The life-time incidence of LBP is 80%.1 It has been suggested that 80–90% of patients will recover in 6 weeks without any intervention.2 In the year follow- ing a first episode of LBP, the pain recurs in 60–86% of patients.3 There appears to be a trend toward chronic LBP with 40% of subjects reporting pain at 6 months and 33% still experiencing pain at 1–2 years.4,5 The human and financial cost of LBP is substantial. There is not a complete understanding of the vul- nerability to recurrence. Instability of the lumbar motion segment is considered to be one important cause.6 A model of spinal stability by Panjabi could provide one explanation for these recurrences.7,8 Panjabi defined spinal instability in terms of a region of laxity around the neutral position of a spinal seg- ment called the ‘neutral zone’. This neutral zone is shown to be increased with intersegmental injury, intervertebral disc degeneration and muscular weak- ness. The size of this neutral zone is influenced by the interaction between what Panjabi described as the passive, active and neural control systems: (i) the pas- sive system constituting the vertebrae, intervertebral discs, zygapophyseal joints and ligaments; (ii) the active system constituting the muscles, and tendons surrounding and acting on the spinal column; and (iii) the neural system comprising the nerves and central ner- vous system which direct and control the active system in providing dynamic stability. Studies have shown that muscles can provide segmental stabilisation by control- ling motion in the neutral zone, and that the neutral © W. S. Maney & Son Ltd 2007 DOI 10.1179/108331907X222949 SPECIFIC SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN – A SYSTEMATIC REVIEW ANNIKA HAUGGAARD1 AND ANN L. PERSSON2 1City Rehab Physiotherapy Clinic, Helsingborg, Sweden 2Rehabilitation and Research Centre for Torture Victims, RCT, Copenhagen, Denmark The aim of this review was to evaluate the effects of specific spinal stabilisation exercises in patients with low back pain (LBP). PubMed and PEDro databases were searched. Ten relevant randomised controlled trials (RCTs) with a study population of patients with acute, sub-acute or chronic LBP were reviewed and quality assessed. The intervention method should have included specific spinal stabilisation exercises including co-contraction of multifidus muscles and transversus abdominis muscles. Seven RCTs were high quality and three were low quality. The results indicate moderate evidence of improved disability and/or pain level, increased multifidi cross-sectional area, and limited evidence for improved quality of life after treatment. The outcome measures used showed extensive heterogeneity. Larger, randomised, controlled trials of high quality, in different subgroups of LBP patients, with long-term follow-up are warranted. A standardisation of outcome measures would be beneficial in order to facilitate comparability among studies. Keywords: Lumbar multifidus, physical therapy, quality assessment, rehabilitation, transversus abdominis Physical Therapy Reviews 2007; 12: 233–248 zone can be returned to within physiological limits by effective muscle control.9–11 All muscles that traverse the lumbar region are capable of contributing to the stabilisation and pro- tection of the lumbar spine.12,13 There are studies sug- gesting that the transversus abdominis muscles and the lumbar multifidus muscles are particularly impor- tant for lumbar segmental stability and for control of motion in the neutral zone.9–11,14,15 The literature reports varying disruptions in the pattern of recruit- ment and co-contraction within and between differ- ent muscle synergies in LBP populations.16 There is evidence of ipsilateral atrophy of the multifidus mus- cles in patients with acute and chronic LBP con- firmed by ultrasound and computed tomography (CT).17,18 In a magnetic resonance image (MRI) study, multifidus muscle atrophy was present in 80% of patients with LBP.19 Hides et al.17 showed that the cross-sectional area of the multifidus muscles in patients with acute LBP was reduced on the sympto- matic side and isolated to one vertebral level (in most cases the clinically determined level of symptoms). The rapid onset and the localised distribution of mus- cle wasting suggested that the mechanism of wasting could not be generalised disuse atrophy or spinal reflex inhibition. The explanation could be inhibition due to perceived pain, via a long loop reflex, prevent- ing movement to protect structures at the level of pathology.17 Biopsies of multifidi in patients with LBP also show abnormalities. Atrophy of type II fibres, and internal structural changes of type I fibres, giving them a ‘moth-eaten’ appearance, have been seen.20 The presence of dysfunction in the deep abdominal muscles in subjects with chronic LBP has also been reported.21,22 Specific stabilisation exercise and motor learning Some authors claim that if there is a deficit of the sta- bilising muscles, incorrect compensation of their activity takes place from the movement muscles if classic exercise techniques are used in rehabilita- tion.23–25 Alterations of the appropriate muscle co- ordination patterns could develop and increase the risk of re-injury to the spine. Instead of using a gen- eral exercise approach, focus should be on specific training of local system muscles, i.e. transverses abdo- minis muscles, diaphragm and multifidus muscles, whose primary role is considered to be the provision of dynamic stability and segmental control to the spine.26,27 This approach is based on the principles of motor learning and skill acquisition. The aim is to train the skilled activation of the deep muscles, to train the integration of the deep and superficial sys- tems, and to progress through a programme of tai- lored functional exercises in varying environments and contexts to ensure transfer to normal activity.23 Motor learning occurs in three main phases – cog- nitive, associative, and autonomous.28 The goal in the initial phase of motor relearning for LBP is to con- tract the deep muscles cognitively to increase the pre- cision and skill of the contraction of the local muscles. An isometric co-contraction of the deep abdominal muscles and multifidus muscles with minimal co-acti- vation of global system muscles should be obtained. Contraction of the pelvic floor muscles will help to inhibit global muscle substitution. It is critical to pro- vide accurate feedback of contraction quality. This may involve any of the senses including tactile (palpa- tion), visual (ultrasound imaging), and auditory (elec- tromyography [EMG] biofeedback) information. Once mastered, the goal shifts to increased precision, increased number of repetitions and holding time, and decreased feedback of performance, success and refinement. This phase involves performance of the task in increasingly challenging positions (e.g. sitting, and standing) and integration of deep and superficial muscle function, for example using leg-loading tasks, proprioceptive neuromuscular facilitation techniques, and postural challenges. The final stage of motor learning, the autonomous phase, is achieved after considerable practice and experience. The task becomes habitual or automatic, and the requirement for conscious intervention is reduced. There are several types of core stability exercises including Pilates exercise, Swiss ball programs, McGill’s stability exercises, balance board training, floor exercise programmes, etc. These programmes aim to restore the capacity (strength and endurance) of the trunk muscles to meet the demands of lum- bopelvic control, whereas the motor learning model describedabove aims to restore the co-ordination and control of the trunk muscles to improve control of the lumbar spine and pelvis.29 The programmes may be used in a motor learning model as progressive train- ing to rehabilitate the integration of the local and global systems for higher-level activities. Stabilisation training is widely used by physiothera- pists in clinical practice, but the clinical evidence for effectiveness of the intervention is not well docu- mented in the literature. Outcome measures The importance of outcome measures in healthcare policy, practice, and research have received wide- spread recognition during the 1990s.30 Different out- come measures are used in order to evaluate the 234 HAUGGAARD AND PERSSON effects of treatment interventions. Seven major types of instruments can be identified in the literature: dis- ease/condition-specific; site-specific; dimension-spe- cific; generic; summary item; individualised and utility.31 Some outcome measures have elements of more than one category. There are eight criteria that investigators should apply to evaluate possible patient-based outcome measures for any specific clin- ical trial: appropriateness; reliability; validity; respon- siveness; precision; interpretability; acceptability; and feasibility.31 Recommendations for outcome measures to be used in LBP research and to evaluate treatment in spinal disorders have been presented.32,33 Five main domains with a ‘core set’ of instruments have been proposed: (i) back-related function measured with Oswestry Disability Questionnaire (ODQ) or Roland Morris Disability Questionnaire (RDQ); (ii) health- related quality of life measured with Short-Form 36 (SF-36) or Short-Form 12 (SF-12); (iii) pain mea- sured with the bodily pain subscale of SF-36 and the number of days experiencing pain; (iv) work-related disability could be measured with SF-36 role limita- tion scales; and (v) patient satisfaction (no particular outcome measure recommended). The World Health Organization (WHO) has also recommended a cluster of tests for use in research on individuals with LBP.34 Examples of these are: pain rating with the Visual Analogue Scale (VAS); physical function with ODQ; anxiety/depression with the Modified Zung and the Modified Somatic Perception Questionnaire (MSPQ); and Range of Motion (ROM) with the Modified Schober. Quality assessment An important aim of reviewing the literature in healthcare is to summarise the evidence on which clinicians need to base their care and thus to provide the empirical basis for clinical decision making.35 Quality assessment of studies is a way of establishing the level of evidence and is an important part of con- ducting reviews in evidence-based medicine. ‘Quality’ as a concept is not easy to define. Quality of randomised controlled trials (RCTs) has been defined as ‘the likeli- hood of the trial design to generate unbiased results’.36 This definition covers only the dimension of internal validity. Most methodological guidelines measure at least three dimensions that may encompass the concept of quality in its broadest sense – internal validity, exter- nal validity, and statistical analysis.35 The present study was performed in order to review the literature for studies involving the treatment inter- vention specific spinal stabilisation training, and investigate what effect it has on patients with LBP. No previous review of clinical trials performed in this field was found from a literature search in PubMed and PEDro. The aims of this review were to evaluate the effects of specific spinal stabilisation training in patients with LBP, and to assess the methodological quality and level of evidence of the studies. METHODOLOGY Selection of studies An extensive search was performed of the PubMed and PEDro databases during October 2005 using the following free text words: ‘specific spinal stabilisation exercises’, ‘stabilisation training’, ‘transversus abdo- minis’, ‘multifidus’, and ‘core strengthening’. The free text words were first used separately and, thereafter, in combination with AND ‘low back pain’, AND ‘rehabilitation’. Search in PubMed was also per- formed using the following Medical Subject Headings (MeSH): ‘Low Back Pain’, ‘Muscle Weakness’, ‘Rehabilitation’, ‘Exercise Therapy’, and ‘Exercise Movement Techniques’. These MeSH terms were also used in combination with the free text words men- tioned above. The search did not give any new rele- vant hits. The search in PubMed was limited to studies published in English, German, French or Swedish, published from January 1985 until October 2005. The search in PEDro was made as an advanced search limited to studies published since 1985. In January 2007, an identical search update was per- formed for the time period 1 October 2005 to 31 December 2006. Titles and abstracts of the identified articles were reviewed to determine the potential relevance of the articles for this review. In addition, references given in the studies retrieved were further examined and search of related articles performed. The study selec- tion procedure is described in Figure 1. Inclusion criteria In order to be included in this review, the studies had to meet the following inclusion criteria: 1. Randomised controlled trials (RCTs) in full text. 2. Studies with a study population consisting of patients with acute, sub-acute or chronic LBP. 3. Studies with an intervention containing specific spinal stabilisation exercises including co-contraction of multifidus muscles and transversus abdominis muscles. SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 235 4. Studies using outcome measures including specific functional questionnaires and/or generic questionnaires and/or pain rating. Exclusion criteria Studies with the following criteria were excluded: 1. Studies with an intervention containing general low back exercises and/or stabilising training without emphasis on a co-contraction of multifidus muscles and transversus abdominis muscles were excluded from this review. 2. Reviews. Quality assessment The methodological quality of the studies was assessed, using guidelines formed by the Cochrane Collaboration Back Review Group (see Appendix).37 In accordance with these guidelines, the studies were independently assessed by two reviewers (Annika Hauggaard [author] and Anders Hauggaard [see Acknowledgements]), and a consensus method was used in order to resolve any disagreements. The reviewers were not blinded to the title, authors, or journal of the study. The conclusion on the effective- ness of the therapeutic intervention was based on the strength of the scientific level of evidence recom- mended by Cochrane.37. The five levels are: (i) strong 236 HAUGGAARD AND PERSSON Fig. 1. Flowchart of study selection procedure. SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 237 Table 1. Summary data for RCTs evaluated Study Cairns et al. (2006)38 Participants 97 patients, aged 18–60 years, who had had a minimum of one previous episode of LBP for which medical care/intervention had been sought Description of intervention The patients were randomised to one group receiving ‘conventional’ physiotherapy (n = 50) consisting of general active exercise and manual therapy, or another group receiving ‘conventional’ physiotherapy plus specific spinal stabilisation exercises (n = 47) with a maximum of 12 treatment sessions during 12 weeks. Both groups received ‘The Back Book’ by Roland et al. Outcomes measured Back-related disability (Roland Morris Disability Questionnaire), pain (Short-Form McGill Pain Questionnaire, 11- point numeric rating scale), psychological distress (Modified Zung and Modified Somatic Perception Questionnaire), generic health (Short-Form 36) Follow-up periods At 6 and12 months Results Both groups showed improved physical functioning, reduced pain intensity, and an improvement in the physical component of quality of life. No statistically significant differences between the two groups were shown for any of the outcomes measured, at any time Authors’ conclusion Patients with LBP had improvement with both treatment packages to a similar degree. There was no additional benefit adding specific spinal stabilisation exercises to a conventional physiotherapy package for patients with recurrent LBP Study Goldby et al. (2006)39 Participants 302 patients, aged 18–65 years, with chronic low back disorder, with the current episode lasting for a minimum of 12 weeks Description of intervention The patients were randomised to manual therapy (n = 121) with a maximum number of 10 interventions, a 10-week spinal stabilisation rehabilitation programme (n = 121) with 1-h classes, or a minimal intervention control group (n = 60) receiving an educational booklet. All groups attended the Back School Outcomes measured Pain intensity (0–100 numerical rating scale, pain diagram, indication of pain during the previous 2 days), disability (Modified Oswestry Disability Index), handicap (Low-Back Outcome Score), impairment (range of lumbar flexion, a timed walking test), quality of life (Nottingham Health Profile) Follow-up periods At 3, 6, 12, 24 months Results Results indicated a statistically significant improvement in favour of the spinal stabilisation group at the 6-month stage in pain and dysfunction and at the 1-year stage in medication, dysfunction and disability Authors’ conclusion As a component of musculoskeletal physiotherapy, the spinal stabilisation programme is more effective than manually applied therapy or an education booklet in treating chronic low back disorder over time. Both manual therapy and the spinal stabilisation programme are significantly effective in pain reduction in comparison to an active control Study Hides et al. (1996)40 Participants 41 patients, aged 18–45 years, with acute LBP (experiencing their first episode of unilateral, mechanical LBP for less than 3 weeks) Description of intervention The patients were randomised to one intervention group (n = 21) receiving specific spinal stabilisation exercises twice per week during 4 weeks, or a control group (n = 21) receiving medical management including advice on bed rest and absence from work and prescription of medication Outcomes measured Pain location, quality and intensity (McGill Pain Questionnaire, VAS, daily pain diaries), disability (Roland Morris Disability Questionnaire), range of motion (oil-filled Rippstein goniometer), straight leg raise (oil-filled goniometer), habitual activity levels (habitual activity questionnaire), multifidus cross-sectional area (ultrasound) Follow-up periods 10 weeks Results Multifidus muscle recovery was not spontaneous on remission of painful symptoms in patients in the control group. Muscle recovery was more rapid and more complete in patients in the intervention group. Other outcome measures were similar for the two groups at the 4-week examination. At the 10-week follow-up, the patients in the control group still had decreased multifidus muscle size although they resumed normal levels of activity Authors’ conclusion Multifidus muscle recovery is not spontaneous on remission of painful symptoms. Lack of localised, muscle support may be one reason for the high recurrence rate of LBP following the initial episode Study Hides et al. (2001)41 Participants 39 patients, aged 18–45 years with acute LBP Description of intervention The patients were randomised to one intervention group (n = 20) receiving specific spinal stabilisation exercises twice per week during 4 weeks, or a control group (n = 19) receiving medical management including advice on bed rest and absence from work and prescription of medication Outcomes measured Recurrence of LBP (telephone questionnaire) Follow-up periods At 1 and 3 years Results Patients from the intervention group experienced fewer recurrences of LBP than patients in the control group. One year after treatment intervention group recurrence was 30% and control group recurrence 84% (P < 0.001). Two to three years after treatment, intervention group recurrence was 35%, and control group recurrence was 75% (P < 0.01) Authors’ conclusion Long-term results suggest that specific exercise therapy in addition to medical management and resumption of normal activity may be more effective in reducing LBP recurrences than medical management and normal activity alone 238 HAUGGAARD AND PERSSON Table 1. (continued) Summary data for RCTs evaluated Study Kladny et al. (2003)42 Participants 99 patients, aged 18–55 years with chronic LBP Description of intervention The patients were randomised to one intervention group (n = 50) receiving specific spinal stabilisation exercises, or one control group (n = 49) receiving general strengthening exercises of abdominal and back muscles, and manual therapy according to Maitland or McKenzie. Length of intervention or number of sessions was not stated Outcomes measured Pain intensity (pain scale Self-Efficacy Scale, numerical rating scale), disability (Oswestry Low Back Pain Disability Questionnaire, Hannover Functional Ability Questionnaire FFbH-R) Follow-up periods At 3 months Results There was a significant functional improvement in both groups measured with the Oswestry score and the FFbH-R. The intervention group showed better values at the end of the treatment. There was also a significant improvement in pain score in both groups but no difference between the groups (P = 0.05) Authors’ conclusion Out-patient rehabilitation improved functional capacity and pain in both groups. Advantages could be seen in the intervention group concerning functional status. The specific stabilisation exercise approach appears to be effective in conservative treatment programs of LBP and lumbar disc disease Study Koumantakis et al. (2005)43 Participants 55 patients (mean age 39.2 years) with recurrent, non-specific LBP and no clinical signs suggesting spinal instability Description of intervention The patients were randomised to a stabilisation-enhanced exercise group (n = 29), or a general exercise-only group (n = 29). Both groups were treated twice a week during 8 weeks Outcomes measured Pain perception (Short-form McGill Pain Questionnaire, pain intensity (VAS), disability (Roland Morris Disability Questionnaire), pain beliefs (Tampa Scale of Kinesiophobia), pain self-efficacy beliefs (Pain Self-Efficacy Questionnaire), pain locus of control (Pain Locus of Control Scale) Follow-up periods At 3 months Results Both groups showed improvements in all outcome measures except the Pain Locus of Control Scale after intervention and at 3-month follow-up. There was a significant difference in the Roland Morris Disability Questionnaire score in favour of the control group after intervention but not at the 3-month follow-up (P =0.05) Authors’ conclusion A general exercise programme reduced disability in the short term to a greater extent than a stabilisation-enhanced exercise approach in patients with recurrent LBP. Stabilisation exercises do not appear to provide additional benefit to patients with sub acute or chronic LBP who have no clinical signs suggesting presence of spinal instability Study Lewis et al. (2005)44 Participants 80 patients, aged 18–75 years, with mechanical LBP (of a non-radicular nature) for more than 3 months Description of intervention The patients were randomised to a 10-station exercise class (n = 40), involving aerobic exercises, stabilisation exercises, manual therapy (~5 min.) for eight 1-h sessions during 8 weeks, or a one-to-one treatment (n = 40), involving eight 30- min sessions of manual therapy and stabilisation exercises during 8 weeksOutcomes measured Disability (Quebec Back Pain Disability Scale), lumbar range of motion, pain intensity (VAS), straight leg raise (inclinometer) Follow-up periods At 6 and 12 months Results Both groups showed significant reduction in the disability questionnaire score and significant increases in range of motion (P =0.05) Authors’ conclusion Both forms of intervention were associated with significant improvement. On-going clinical research is necessary to provide guidance as to the clinical efficacy of various forms of intervention Study Niemistö et al. (2003)45 Participants 204 patients with chronic low back pain aged 24–46 years Description of intervention The patients were randomised to an intervention group receiving manipulation, stabilisation exercises and stretching (n = 102) or a control group receiving no treatment (n = 102). Both groups received an educational booklet, information about LBP, individual instructions regarding posture and ergonomics and 3–4 home exercises Outcomes measured Pain intensity (VAS and frequency of LBP), back-specific disability (Oswestry Low Back Pain Disability Questionnaire) Follow-up periods At 5 and 12 months Results At 5- and 12-month follow-up, the intervention group showed more significant reductions in pain intensity (P < 0.001) and self-rated disability (P = 0.002) than the control group. There was no significant difference between the groups in health-related quality of life Authors’ conclusion The manipulative treatment with stabilisation exercises was more effective in reducing pain intensity and disability than the physician’s consultation alone (control group). Short, specific, treatment programmes with proper patient information may alter the course of chronic LBP Study O’Sullivan et al. (1997)46 Participants 44 patients, aged 16–49 years, with recurrent LBP pain (with or without radiating pain to lower limbs) where symptoms had persisted more than 3 months. The patients should have the radiological diagnosis of spondylolysis or spondylolisthesis Description of intervention The patients were randomised to a specific exercise group (n = 22) treated with stabilisation exercises during 10 sessions over a 10-week period plus daily home exercises, or a control group (n = 22) where the 10-week treatment consisted of general exercises such as swimming, walking and gym work directed by each patient’s medical practitioner Outcomes measured Pain (Short-Form McGill Pain Questionnaire), disability (Oswestry Disability Questionnaire), lumbar spine and hip sagittal range of movement in standing (Cybex Electronic digital inclinometer) evidence – consistent findings among multiple, high- quality RCTs; (ii) moderate evidence – consistent findings among multiple, low-quality RCTs and/or one high-quality RCT; (iii) limited evidence – one low-quality RCT; (iv) conflicting evidence – inconsis- tent findings among multiple trials (RCTs); and (v) no evidence – no RCTs. RESULTS Study selection The original search in the PubMed and PEDro data- bases gave a total of 977 references, of which 872 were excluded immediately from reading the abstract because they were considered irrelevant to this review. The num- ber of relevant references from the first screening process was 105. Of these, 63 were excluded since they were duplicates, and another 34 were excluded because they did not fulfil the selection criteria (Fig. 1). In the original selection, eight RCTs were found that met the inclusion criteria. In the search update made in January 2007, two additional RCTs met the inclusion criteria giving a total of ten RCTs38–47 that were included in the current sys- tematic review. All articles found were published in English except for one article that was published in German.42 Two of the studies were related, since one was a long-term follow-up from the same study group.40,41 Interventions The stabilisation exercise programme used in all the selected studies was based on the principle of a co- contraction of multifidus muscles and transversus abdominis muscles following the motor learning model.26 A summary of the reviewed studies is pre- sented in Table 1. In three of the studies,38,44,45 the intervention group received other treatments such as manipulation, stretching, manual therapy and/or general exercises in addition to stabilisation exercises. Lewis et al.44 used a 10-station exercise class in the control group involving aerobic exercises, manual therapy, and stabilisation exercises. Koumantakis et al.43 combined the stabili- sation exercises with general exercises in the interven- tion group. The general exercises were similar in both the intervention group and the control group, but were introduced in the intervention group at a later stage when the patients were able to perform the sta- bilisation exercises properly. There was no intervention at all in the control group in one study.47 In the study by Niemistö et al.,45 both groups received an educational booklet, infor- mation about LBP, individual instructions regarding posture and ergonomics and home exercises. In the study of Goldby et al.,39 there were three groups, one group given stabilisation exercises, one group treated with manual therapy and a third group given an edu- cational booklet. In the other studies, the intervention for the control group was medication, bed rest and absence from work,40,41 general exercise pro- grammes,38,42–44,46 and in three studies additional manual therapy.38,42,44 The duration of the intervention period varied. Three studies had a 4-week intervention period.40,41,45 Two studies had an 8-week intervention period,43,44 three studies a 10-week intervention period39,46,47 and one study a 12-week intervention period.38 Kladny et al.42 did not specify the number of treatment sessions or the length of the intervention period. The follow-up SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 239 Table 1. (continued) Summary data for RCTs evaluated Follow-up periods At 3, 6 and 30 months Results The specific exercise group showed significant reduction in pain intensity and functional disability levels which was maintained at the 30-month follow-up. The control group showed no significant change in these parameters (P < 0.05) Authors’ conclusion An approach with specific spinal stabilisation exercises appears more effective than other commonly prescribed conservative treatment programmes in patients with chronically symptomatic spondylolysis or spondylolisthesis Study Shaughnessy & Caulfield (2004)47 Participants 41 patients, aged 20–60 years, with complaints of LBP for a minimum of 3 months Description of intervention The patients were randomised to a treatment group (n = 20) which underwent 10 sessions of spinal stabilisation exercises during 10 weeks plus daily home exercises, or a control group (n = 21) receiving no intervention Outcomes measured Disability (Oswestry Disability Questionnaire, Roland Morris Disability Questionnaire), perceived quality of life (Short-Form 36) Follow-up periods None Results Significant improvements were seen in all measures in the treatment group whereas control subjects demonstrated either no change or a significant worsening (P < 0.05) Authors’ conclusion The results suggest that a programme of lumbar stabilisation exercises is effective in improving quality of life and functional outcome in patients with chronic LBP period varied from 4 weeks to 3 years. The study pop- ulation in the included studies varied in size (mean n = 100, median n = 68, and range 39–302; see Table 1). Outcome measures The outcome measures used in the reviewed studies showed an extensive heterogeneity. A summary of the outcome measures is presented in Table 2. In total, there were 26 outcome measures and, of these, 18 were used in single studies. All studiesincluded an outcome measure for assessment of functional dis- ability. The ODQ was used in four studies,42,45–47 the Modified Oswestry Disability Questionnaire (MODQ) in one study,39 and the RDQ, which is regarded to have similar qualities as the ODQ,48 was used in four of the studies.38,40,43,47 The Baecke Questionnaire of Habitual Physical Activity was used in one study,40 and the Quebec Back Pain Disability Scale (QBPDS) in one study.44 Pain intensity was assessed in all of the studies. The VAS was used in four studies.40,43–45 The Numeric Pain Rating Scale (NRS), which has similar features as VAS, was used in three studies.38,39,42 The McGill Pain Questionnaire (MPQ) or the shorter version Short- Form McGill Pain Questionnaire (SF-MPQ) were used in four of the studies.38,40,43,46 Four studies used ROM as an outcome mea- sure.39,40,44,46 Four studies used a generic health status measure, the SF-36,38,47 the Nottingham Health Profile (NHP),39 and the 15D-measure.45 Two studies used out- come measures for psychological distress.38,45 Cairns et al.38 combined the Modified Zung and the MSPQ according to the Distress and Risk Assessment Method (DRAM),49 and Niemistö et al.45 used the 240 HAUGGAARD AND PERSSON Table 2. Domains and outcome measures used in the 10 reviewed RCTs Domain Outcome measure Type Used in study Pain perception VAS Summary item 40,43,44,45 NRS Summary item 38,39,42 SES Dimension specific 42 MPQ Dimension specific 40 SF-MPQ Dimension specific 38,43,46 Pain diary Dimension specific 40 Pain beliefs TSK Dimension specific 43 PSEQ Dimension specific 43 PLC Dimension specific 43 Psychological distress Modified Zung Dimension specific 38 MSPQ Dimension specific 38 DEPS Dimension specific 45 Functional status RDQ Disease/condition specific 38,40,43,47 ODQ Disease/condition specific 42,45,46,47 MODQ Disease/condition specific 39 QBPDS Disease/condition specific 44 FFbH-R Dimension specific 44 Baecke Questionnaire Dimension specific 40 Health status SF-36 Generic 38,47 NHP Generic 39 15D-measure Generic 45 Physical examination ROM Not applicable 40,44,46 SLR Not applicable 40,44 Timed walking test Not applicable 39 Other CSA Not applicable 40 Phone questionnaire Disease/condition specific 41 VAS, Visual Analog Scale; NRS, Numeric Pain Rating Scale; SES, Pain Experience Scale; MPQ, McGill Pain Questionnaire; SF-MPQ, Short-Form McGill Pain Questionnaire; TSK, Tampa Scale of Kinesiophobia; PSEQ, Pain Self-Efficacy Questionnaire; PLC, Pain Locus of Control Scale; MSPQ, Modified Somatic Perception Questionnaire; DEPS, Finnish Depression Questionnaire; RDQ, Roland-Morris Disability Questionnaire; ODQ, Oswestry Disability Questionnaire; MODQ, Modified Oswestry Disability Questionnaire; QBPDS, Quebec Back Pain Disability Scale; FFbH-R, Hannover Functional Ability Questionnaire; SF-36, Short-Form 36; NHP, Nottingham Health Profile; ROM, range of motion; SLR, straight leg raise; CSA, cross-sectional area. Finnish Depression Questionnaire (DEPS). Koumantakis et al.43 were the only authors using out- come measures in order to evaluate pain beliefs and anxiety using the Tampa Scale of Kinesiophobia (TSK), the Pain Self-Efficacy Questionnaire (PSEQ), and the Pain Locus of Control Scale (PLC). Work- related disability and patient satisfaction were not reported in any of the studies. Studies with positive outcome Positive outcome was defined as statistically signifi- cantly better outcome after treatment intervention com- pared to other treatments or placebo. In three of the studies,39,45,46 the intervention group showed significant reduction in pain intensity and self-rated disability com- pared to the control group, which was maintained at the follow-up periods (Table 1). In Shaughnessy and Caulfield’s study,47 a significant improvement in all out- come measures, ODQ, RDQ, SF-36, was seen in the intervention group after 10 weeks compared to no change or a significant worsening in the control group. In the study by Hides et al.,40 the multifidus muscles cross sectional area was increased in the intervention group at both 4- and 10-week follow-up but not in the control group. A second, long-term follow-up study by the same authors41 showed that the patients in the intervention group had fewer recurrences of LBP at both 1-year follow-up and at 3-year follow-up. The percentage of recurrences was for the intervention group 30% and 35%, and for the control group 84% and 75%, respectively. Studies with indifferent outcome Indifferent outcome was defined as no statistically sig- nificant difference in outcome after treatment interven- tion compared to other treatments or placebo. Cairns et al.38 reported improved physical function- ing measured with the RDQ for both intervention group and control group. No statistically significant differences between the two groups were shown for any of the outcomes measured at any time. Hides et al.,40 who examined patients with acute LBP, reported similar outcome results for both inter- vention group and control group at 4- and 10-weeks follow-up regarding reduced levels of pain and dis- ability and increased ROM (Table 1). Kladny et al.42 reported improved functional capac- ity in both intervention group and control group, but more in the intervention group. There was also a sig- nificant improvement in pain scores with similar results in both groups. Koumantakis et al.43 stated that both intervention group and control group showed improvements in all outcome measures except the PLC after the interven- tion and at 3-month follow-up. There was a signifi- cant difference in RDQ in favour of the control group after intervention but not at the 3-month follow-up. Lewis et al.44 reported significant reduction in dis- ability and significant increase in ROM in both inter- vention group and control group. Niemistö et al.45 concluded that there was no significant difference between the groups regarding quality of life. Studies with negative outcome Negative outcome was defined as statistically signifi- cant worse outcome after treatment intervention compared to other treatments or placebo. None of the reviewed studies presented a negative outcome stated as above. Methodological quality The methodological quality of the 10 RCTs according to the Method Guidelines from the Cochrane Collaboration Back Review Group is described in Table 3. Assessed by this guideline, seven of the studies were of high quality with scores of at least 6 out of 11,38,40,41,43–46 and three studies were of low quality.39,42,47 The mean quality score was 6.8, and the median score was 6, ranging from 5 to 10 points out of a total of a pos- sible 11 points (Table 3). Not all the methodological cri- teria were met in the studies reviewed. For example, the criteria ‘blinding of subjects’ was difficult to obtain due to study design. Some studies did not clearly specify if a criterion was met, and consequently the criterion was scored as ‘don’t know’. Evidence of outcome Significant improvement in pain and disability levels for the group treated with specific stabilisation exer- cises was reported in two studies of high methodolog- ical quality,45,46 and two studies of low quality.39,47 The level of evidence for reduced pain and disability must, therefore, be considered as moderate. Other effects seen from specific stabilisation train- ing were improved multifidus muscle recovery40 resulting in fewer recurrences during a follow-up period of 3 years;41 however, since there was only one study of high quality confirming these outcomes, the level of evidence must be considered as moderate. One study showed a positive outcome measuring SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 241 quality of life.47 Since this study was of low quality, the level of evidence mustbe considered as limited. In conclusion, this review suggests moderate evi- dence for improved pain and disability levels and increased multifidus muscle cross-sectional area, and limited evidence for improved quality of life after the use of specific spinal stabilisation exercises as a treat- ment intervention for patients with LBP. DISCUSSION Although LBP is a wide-spread and disabling condi- tion, there is a lack of evidence-based medicine with respect to its treatment and rehabilitation. There is a general consensus in the literature supporting the need for active exercise therapy in the treatment of LBP.50 Unfortunately, there is little agreement on which exercise regimens that are most effective. In a review regarding exercise therapy for LBP made by the Cochrane Collaboration Back Review Group,51 the authors concluded that exercise therapy does not seem to be effective for acute LBP, but that exercises may be helpful for patients with chronic LBP. The types of exercise programmes for chronic LBP vary widely from land-based exercise versus exercise in water, to isolated trunk exercise versus a walking pro- gramme. Therefore, exercise can not be regarded as a single class of treatment and reviewers summarising trials need to take this variety into consideration. In recent times, specific spinal stabilisation programmes aimed at enhancing strength and re-education of the local stabilisers in the lumbar region have increased in popularity in the treatment of LBP.52 The current review was conducted in order to investigate the effects reported from clinical trials using this specific treatment intervention. Study design and populations In order to analyse and summarise the data from the included studies, a qualitative review was undertaken. This in line with the recommendations from the Editorial Board of the Cochrane Back Review Group who state that a meta-analysis should be avoided if relevant, valid data are lacking, (e.g. data are too sparse or of too low quality), or if data are statistically and clinically too heterogeneous.53 A grading system for lev- els of evidence was used for this purpose. The study population and outcome measures dif- fered in the studies (Table 1). All patients suffered from LBP, but in the Hides et al. study40 the patients had acute LBP, in the O’Sullivan et al. study46 the patients had a radiological diagnosis of spondylolysis or spondylolisthesis, whereas in the rest of the studies the study population had sub-acute LBP or chronic LBP. In two studies, co-interventions were used,42,44 and in two other studies it was unclear if co-interven- tions were used.45,46 In the Lewis et al. study,44 stabili- sation exercises were part of the treatment intervention in both the groups studied. In group 1 (exercise class) it was used in combination with other exercises, and in group 2 (individual treatment) in combination with 242 HAUGGAARD AND PERSSON Table 3. Methodological quality assessment of the 10 reviewed RCT studies Cairns et al. Goldby et al. Hides et al. Hides et al. Kladny et al. Koumantakis Lewis et al. Niemistö O’Sullivan Shaughnessy & Criteria (2006)38 (2006)39 (1996)40 (2001)41 (2003)42 et al. (2005)43 (2005)44 et al. (2003)45 et al. (1997)46 Caulfield (2004)47 1. + + + + + + + + + ? 2. + + ? ? ? + + + + ? 3. + – + + + + – + + + 4. + – – – – + – – – – 5. – – – – – – – – – – 6. + + + + + + + + + + 7. + + + + – + – ? ? + 8. + – + + ? + – + ? ? 9. + – ? + + + + + + + 10. + + + + + + + + + + 11. + – – – – + + + – – Quality High Low High High Low High High High High Low (points) (10/11) (5/11) (6/11) (7/11) (5/11) (10/11) (6/11) (8/11) (6/11) (5/11) The Cochrane Method Guidelines criteria list37 (Yes, +; No, –; and Don’t know, ?). Criteria: 1. Was the method of randomisation adequate?; 2. Was the treatment allocation concealed?; 3. Were the groups similar at baseline regarding to the most important prognostic indicators?; 4. Was the patient blinded to the intervention?; 5. Was the care provider blinded to the intervention?; 6. Was the outcome assessor blinded to the intervention?; 7. Were co-interventions avoided or similar?; 8. Was the compliance acceptable in all groups?; 9. Was the drop-our rate described and acceptable?; 10. Was the timing of the outcome assessments in all groups similar?; 11. Did the analysis include an intention-to-treat analysis?; Result: 6/11 points or more are defined as high quality. manual therapy techniques. A significant disability reduction was found in both groups (Table 1). Due to the fact that stabilisation exercises were used in both groups, it can be argued that the study should have been excluded from this review, since the effect of sta- bilisation training alone can not be distinguished. In another study, the treatment group was compared to a control group which received no intervention.47 The hands-on effect in certain trials, where the par- ticipants in the control group had a limited number of appointments with the physiotherapist or no intervention at all, should not be neglected. There may be a positive association between the number of contacts with the healthcare providers and improve- ment of back-related symptoms.54 Considering that the basic stabilising exercises with the co-contraction of transversus abdominis muscles and multifidus muscles take some time to master, the 4-week intervention period in some of the stud- ies40,41,45 is relatively short. O’Sullivan et al.46 reported that several subjects in their trial took as long as 4 or 5 weeks of specific training before an accurate pattern of co-contraction could be achieved. The feed-back given by the physiotherapist regarding the perfor- mance of the exercises is also important, since the patients otherwise might not complete the co-con- traction successfully. This feed-back was not given in all studies. Not all studies measured the patient com- pliance with the treatment intervention. Since the aim of the method is that the co-contraction of transver- sus abdominis muscles and multifidus muscles should be used in daily tasks, and the stabilisation exercises performed on a daily basis, it is important to measure compliance in order to evaluate the patients’ activity during the intervention period. Outcome measures The outcome measures used in the studies showed extensive heterogeneity (Table 2). The most common outcome measures were pain and back specific func- tion. The fact that similar functional outcome mea- sures were used in eight of the studies, RDQ, ODQ and MODQ,38–40,42,43,45–47 facilitates comparison between results for disability. The RDQ and ODQ are widely used questionnaires with similar structure.48 With reference to the outcome measures recom- mended in back pain studies,32–34 there was a lack of instruments measuring health-related quality of life, work-related disability, patient satisfaction, and depression. It is important to keep in mind that pain and dis- ability in patients with chronic LBP are complicated phenomena that cannot be explained by physical factors alone.55,56 However, biomechanics still play a major role in the spinal pathology and LBP. Waddell57 sug- gested that sometimes illness behaviour can become as disabling as the original physical problem and may even become the major management problem. Psychological factors (distress, depressive mood, and somatisation) are implicated in the transition to chronic LBP.58 Early identification of these risk fac- tors (for example, by use of a screening questionnaire for psychosocial risk factors) may lead to more effec- tive treatment by identifying which patients are likely to benefit from behavioural treatment.59 The psycho- social component involved in LBP is also important to assess with health-related outcome measures like the SF-36. This type of outcome measure was only used in four ofthe studies.38,39,45,47 Fear-avoidance and self-efficacy beliefs are also considered important fea- tures for development of chronic LBP,60 and were only examined by Koumantakis et al.43 The WHO recommends the use of outcome measures for anxiety/ depression with the Modified Zung and the MSPQ.34. These measures were only used in one trial;38 the DEPS, another outcome measure for depression, was used in one trial.45 Methodological quality Despite some differences in methodological score, there were no disagreements between the two review- ers on which study was of low or high quality. The level of disagreement between the reviewers was only 4.5%. Seven out of the 10 RCTs were assessed as hav- ing a high quality (6–10 points of 11 possible; Table 3). It should, however, be noted that three of the stud- ies40,44,46 achieved a score of 6, the minimum score to be defined as a high-quality study. In several studies there was lack of data needed for the methodological assessment and when important data are missing the result of the methodological assessment can be questioned. Many methodological criteria were not fulfilled. Randomisation, blinding of patients and outcome assessors, tracking of co-inter- ventions and compliance were not properly con- ducted in some of the studies. Blinding of the care providers in this type of trial is difficult, if not impos- sible. Blinding of patients is also difficult. In two of the trials, the treatment credibility was evaluated and the treatments were equally credible and acceptable to patients.38,43 The criteria regarding patient blinding were, therefore, in these trials scored as a ‘yes’. Blinding of the outcome assessor should, however, be possible. In some of the trials this was not stated clearly but it was mentioned that the follow-up con- sisted of patient-completed outcome measures only. SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 243 In these cases, the question about outcome assessor blinding was scored as a ‘yes’. Evidence of outcome In this review there were two trials of high method- ological quality,45,46 and two of low quality,39,47 where the results confirmed reduced levels of pain and dis- ability. The consensus among the Editorial Board of the Cochrane Back Review Group is that strong evi- dence can only be provided by multiple, high-quality trials that replicate findings of other researchers in other settings.37 Consequently, the level of evidence for reduced pain and disability was judged as moder- ate. One of these studies45 used additional treatment interventions apart from stabilisation exercises in the intervention group. For that reason, a separate analy- sis of the effectiveness of stabilisation exercises only can not be made. Moreover, the other study46 had a study population of patients with spondylolysis or spondylolisthesis; therefore, conclusions can only be drawn regarding these two diagnoses.46 Hence, it might be a limitation that studies with sub-groups and additional treatment interventions apart from stabilisation exercises were included in the present review. Nevertheless, it can be of value to discover that certain sub-groups with LBP might benefit more from this specific treatment. The conclusion by Goldby et al.39 needs careful consideration due to the high drop-out rate in the trial. Only 66% of the ran- domised subjects completed treatment, only 62% were followed up at 3 months, and even fewer at the 6-, 12-, and 24-month follow-ups. The data analysis in the study was not based on the intention-to-treat approach. Only one study of high methodological quality (6/11 points) investigated the effect of stabilisation exercises on the multifidus cross sectional area.40 Thus, based on the results from this single trial only, it can be questioned if it is adequate to consider the level of evidence as moderate. Regarding quality of life, only one low-quality study showed positive out- come,47 so the level of evidence must here be consid- ered as limited. Other studies and reviews There has been a recent, well-conducted RCT with a 2-year follow-up on patients with pelvic girdle pain after pregnancy.61,62 Eighty-one women were ran- domly assigned to two treatment groups for 20 weeks. One group performed stabilisation exercises and the other group received individualised physical therapy without stabilisation exercises. Outcome measures used were VAS, MODQ and the SF-36. There were no drop-outs in the study. The results showed significant lower pain intensity, lower disability and higher qual- ity of life in the intervention group compared with the control group, after the intervention period, and at 1 and 2 years post partum. The results from this trial and the result of O’Sullivan et al.46 (studying patients with the diagnosis spondylolysis or spondylolisthesis) indicate that stabilisation exercises might be specifi- cally effective for patients with low back instability and sacro-iliac joint laxity. This is in line with recent research showing that contraction of the transversus abdominis significantly decreases the laxity of the sacroiliac joints.63 Two cohort studies within this field have been pub- lished.64,65 One was conducted on 54 patients with subacute LBP64 who received stabilisation exercises twice weekly during 8 weeks and were requested to perform daily home exercises. Disability was mea- sured with MODQ and served as the reference stan- dard to determine success of the treatment programme. Eighteen subjects were categorised as treatment success (≥ 50% change in MODQ score), 15 as treatment failures and 21 as somewhat improved. The other cohort study65 was conducted on 16 patients with chronic LBP who performed five differ- ent stabilisation exercises and were supervised 3 times weekly for 4 weeks. ODQ scores showed a significant improvement of the functional status after 4 weeks. These trials had no control group but both results indicate that specific stabilisation exercises seem to have a positive effect on disability. Five reviews regarding stabilisation exercise train- ing were retrieved,25,29,52,66,67 but not included in the present review (Fig. 1). These reviews focus mainly on the concepts behind lumbar stabilisation and core strengthening and do not compare the quality and results from clinical trials as is done in this review. The proven decreased multifidus muscle size in patients with LBP appears to be similar to the reflex inhibition of muscles surrounding the knee resulting in hypotrophy of the vastus medialis muscle, and can occur in the absence of pain.40,68 The positive natural history of acute LBP in the short term, might lead to an underestimation of the importance of early inter- ventions, which aim to prevent recurrences. The con- trol group at the long-term follow-up in the study by Hides et al.41 showed that the recurrence rate was high during the first year (84%) after the original episode. Restored symmetry of muscle size in the multifidus muscles at the segmental level after the specific exer- cise programme was shown in the specific exercise group, but was not found in the control group. The implication may be that such a specific programme is necessary during the first stage of rehabilitation before 244 HAUGGAARD AND PERSSON introduction of more generalised stabilisation training, so that muscle control at the segmental level might be assured.40 Hides et al.41 did not measure the cross-sec- tional area in the long-term follow-up, which would be of interest to do in future studies in order to see if the increase in cross-sectional area persists over time. Future research Clinical research concerning intervention outcome in LBP treatment is often difficult. Many of the muscles tested are deeply situated and require invasive instru- ments to determine muscular activity accurately.It is often difficult to judge what different degrees of strength, flexibility, and movement patterns should be considered ‘normal’ or clinically significant. Long-term change that occurs because of exercise depends on the subject’s motivation, effort, and compliance with the programme. It may be difficult to design adequate placebo controls. The natural history of back pain fur- ther complicates this research. Each episode of back pain generally has a good prognosis,2 and studies that look at recurrences need to have frequent, long-term fol- low-up to capture differences between groups. If only patients with persistent back pain are studied, central and peripheral pain processing problems may have a major contribution to the persistence of the pain, and symptoms may not change as muscle function improves. We agree with authors of other studies and reviews that, in order to establish stronger evidence for the therapeutic intervention, well-designed studies with larger study groups and long-term follow-up need to be conducted. There is also a challenge to identify if there are certain sub-groups of LBP patients that are more likely to benefit from this treatment approach than others. An on-going RCT is now performed by an Australian research group who are also completing a systematic review.69 It would be beneficial if the research community could agree to standardise outcome measures in order to facilitate comparability among studies. Preferably there should, apart from pain rating and functional outcome measures, be some outcome measures included for assessment of fear-avoidance behaviour, self-efficacy beliefs and health-related quality of life. The use of valid and reliable outcome measures as described by an international group of experts in the LBP field is advocated for future studies.32,33 CONCLUSIONS Ten RCTs using specific spinal stabilisation exercises in the treatment of patients with LBP were reviewed. The majority of the studies were of high quality when assessed according to the Cochrane Method Guidelines. Results suggest moderate evidence of improved disabil- ity level, reduced pain level and increased multifidi cross sectional area, and limited evidence for improved qual- ity of life. The outcome measures used in the studies showed extensive heterogeneity. Future research with RCTs of high quality and with long-term follow-up is needed in order to evaluate the treatment intervention properly. Studies using the treatment intervention on different sub-groups of LBP patients are also warranted. ACKNOWLEDGEMENTS We wish to thank Jörgen Kristensen MD PhD and Anders Hauggaard MD for contributing with helpful suggestions and constructive discussions, and specifi- cally Anders Hauggaard for participating as reviewer in the method quality assessments. REFERENCES *Indicates the most important references. 1 McCormick A, Fleming D, Charlton J. Morbidity Statistics from General Practice. Fourth National Study 1991–1992. Office of Population Censuses and Surveys. Series MB5 No. 3. 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Is there a role for transversus abdominis in lumbo- pelvic stability? Man Ther 1999;4:74–86 67 Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil 2004;85(Suppl 1):86–92 68 Stokes M, Young A. Investigations of quadriceps inhibition: Implications for clinical practice. Physiotherapy 1984;70:425–8 69 Maher CG, Latimer J, Hodges PW, Refshauge KM, Moseley GL, Herbert RD et al. The effect of motor control exercise versus placebo in patients with chronic low back pain. BMC Musculoskel Disord 2005;6:54 SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 247 ANNIKA HAUGGAARD PT (for correspondence) City Rehab Sjukgymnastik, Norra Strandgatan 13, SE-252 20 Helsingborg, Sweden Fax +971 3 7670051; E-mail: moresand@emirates.net.ae ANN L. PERSSON PT PhD Rehabilitation and Research Centre for Torture Victims, RCT, Postbox 2107, DK-1014 Copenhagen K, Denmark Tel: +45 33 760000; Fax: +45 33 760510; E-mail: ap@rct.dk APPENDIX see next page Was the method of randomisation adequate? A random (unpredictable) assignment sequence. Examples of adequate methods are computer-gener- ated random-number table and use of sealed envelopes. Methods of allocation using date of birth, data admission, hospital number, or alternation should not be regarded as appropriate Was the treatment allocation concealed? Assignment generated by an independent person not responsible for determining the eligibility of the patients. The person has no information about the persons included in the trial and has no influence on the assignment sequence or on the decision about eli- gibility of the patient Were the groups similar at baseline regarding to the most important prognostic indicators? In order to receive a ‘yes’, groups have to be similar at baseline regarding to demographic factors, duration, and severity of complaints, percentage of patients with neurological symptoms, and value of main out- come measure(s) Was the patient blinded to the intervention?The reviewer determines if enough information about the blinding is given in order to score a ‘yes’ Was the care provider blinded to the intervention? The reviewer determines if enough information about the blinding is given in order to score a ‘yes’ Was the outcome assessor blinded to the intervention? The reviewer determines if enough information about the blinding is given in order to score a ‘yes’ Were co-interventions avoided or similar? Co-interventions should either be avoided in the trial design or similar between the index and control group Was the compliance acceptable in all groups? The reviewer determines if the compliance to the inter- vention is acceptable based on the report intensity, duration, number and frequency of sessions for both the index intervention and control intervention(s) Was the drop-out rate described and acceptable? The number of participants who were included in the study but did not complete the observation period or were not included in the analysis must be described and reasons given. If the percentage of withdrawals and drop-outs does not exceed 20% for short-term follow-up and 30% for long-term follow-up and does not lead to substantial bias. a ‘yes’ is scored. (NB these percentages are arbitrary, not supported by the literature) Was the timing of the outcome assessments in all groups similar? Timing of outcome assessment should be identical for all intervention groups and for all important outcome assessments Did the analysis include an intention-to-treat analysis? All randomisation patients are reported/analysed in the group they were allocated to by randomisation for the most important moments of effect measurement (minus missing values) irrespective of non-compli- ance and co-interventions Result 6/11 or more are defined as high quality 248 HAUGGAARD AND PERSSON APPENDIX THE COCHRANE METHOD GUIDELINES37
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