PROSPERO International prospective register of systematic reviews

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1 PROSPERO International prospective register of systematic reviews Prognostic factors for pain and functional recovery following physiotherapy management for musculoskeletal shoulder pain Rachel Chester, Christina Jerosch-Herold, Lee Shepstone, Jeremy Lewis, David Sweeting, Helena Daniels Citation Rachel Chester, Christina Jerosch-Herold, Lee Shepstone, Jeremy Lewis, David Sweeting, Helena Daniels. Prognostic factors for pain and functional recovery following physiotherapy management for musculoskeletal shoulder pain. PROSPERO 2011:CRD Available from Review question(s) What are the potential prognostic factors for pain and functional recovery following physiotherapy management for musculoskeletal shoulder pain? Searches A number of databases will be searched for relevant studies from 1991 to the present (detailed within search strategy). Only publications in English will be included. The title (and translated abstracts) of publications which may otherwise have been included in the review, will be presented in English in an appendix. Types of study to be included Inclusion criteria: 1) Prospective studies. 2) Any of the following: a) Controlled trials which carry out a subgroup analysis relating outcome in one or more arm of physiotherapy treatment to baseline variables. b) Controlled trials in which two or more groups of subjects, different at baseline, receive the same physiotherapy treatment/package. c) Controlled trials in which two or more groups of subjects, different at baseline, receive different management (physiotherapy intervention(s)/control/placebo) *but when each group receiving physiotherapy is treated as an independent cohort and potential prognostic factors within that group related to outcome. d) Longitudinal cohort studies. 3) Studies which include anatomical regions in addition to the shoulder but report results for the shoulder as a distinct anatomical region. 4) Studies which do and/or do not state adherence to or completion of physiotherapy treatment. This is because studies only including participants who complete physiotherapy are rare. 1) Retrospective studies 2) Single case studies 3) Controlled trials in which two or more groups of subjects, different at baseline, receive different management Page: 1 / 7

2 (physiotherapy intervention(s)/control/placebo). (See * for exception). 4) Studies which include anatomical regions in addition to the shoulder but do not report results for the shoulder as a distinct anatomical region. Condition or domain being studied Physiotherapy management of musculoskeletal shoulder pain in any primary, secondary or private healthcare setting or equivalent, worldwide. Participants/ population Inclusion criteria: 1) Any person, irrespective of age, with musculoskeletal shoulder pain of any duration, identified as such by any health practitioner. 2) Reproduction of shoulder pain on active or passive movement of the glenohumeral joint in at least one direction. 1) Fracture(s) of the scapula, humerus or clavicle of the shoulder receiving physiotherapy treatment within the last two years. 2) Surgery, within the last two years, of the shoulder receiving physiotherapy. 3) Traumatic dislocation, within the last two year, of the shoulder receiving physiotherapy. 4) Patients with a stated systemic condition which has a significant musculoskeletal component (i.e. inflammatory joint disease, polymyalgia rheumatica, neoplastic disorder). 5) Complex regional pain syndrome. 6) Predominant reproduction of shoulder pain on movements of the cervical or thoracic spine rather than shoulder movement. 7) Upper quadrant pain or neck/shoulder pain, from the description or presentation of which, it is not possible to judge whether the symptoms are arising from the spine or shoulder. 8) Neck pain related to serious pathology (i.e myelopathy) or radiculopathy. 9) Studies on general musculoskeletal or upper quadrant pain, without specific results for the shoulder. Intervention(s), exposure(s) Any specific intervention or package of care must be delivered by, or involve, one or more physiotherapist. The physiotherapist must be state registered or the equivalent within the country in which the study took place as recognised by the World Congress of Physiotherapists. The physiotherapist does not have to deliver all aspects of physiotherapy care but must have had some face to face contact with the patient and be involved in the decision making process. For example some treatments may be delivered by a physiotherapy assistant. Treatments or packages of care must include one or more or the following: 1) Advice provided by a physiotherapist involving some face to face contact. 2) Exercise prescribed by a physiotherapist involving some face to face contact. This may include any of the following: a). A home exercise programme with or without regular follow up. Page: 2 / 7

3 b) Supervised and/or unsupervised exercises. c) Classes run by a physiotherapist or physiotherapy assistant (this may include instruction of exercises specific to the shoulder or general exercise). d) Hydrotherapy (this may include instruction of exercises specific to the shoulder or general exercise). 3) Electrotherapy. This must be one or more of the following: TENS, short wave diathermy, ultrasound, laser. 4) Acupuncture (delivered by a physiotherapist). 5) Manual therapy delivered by a physiotherapist. This must include one or more of the following: massage, frictions, trigger points, stretches, mobilisations, manipulation. 6) Local injection of steroid and/or anaesthesia or hydrodilatation into the shoulder region (delivered by a physiotherapist). 7) The following packages of care, in which the physiotherapist works as a member of a healthcare team delivering one or more of the treatments above will be included: a) Pain management programmes b) Local injection of steroid and/or anaesthesia or hydrodilatation delivered by another healthcare member. c) Pain medication prescribed by a Medic or Pharmacist. d) Sports rehabilitation team. e) Work related rehabilitation team. 1) GP management which does not involve any form of physiotherapy as outlined within the inclusion criteria. 2) Physiotherapy treatments delivered solely by other healthcare professionals, sports therapists, osteopaths, chiropractors, general practitioners, complimentary practitioners, or physiotherapy assistants or technicians, in which a qualified physiotherapist plays no role in the assessment or decision making. This includes for example acupuncture, ultrasound, ice and/or heat therapy, advice, and leaflets on physiotherapy exercises. 3) Treatment over the telephone in which there is no face to face contact with a physiotherapist. 4) Ice/hot packs as the only form of physiotherapy. Comparator(s)/ control Rather than investigate the effectiveness of an intervention this systematic review seeks to identify demographic characteristics and clinical assessment findings that correlate with patient outcome. Potential prognostic factors must be collected prior to commencing physiotherapy treatment. These include the following: 1) Demographic details. 2) Individual participant characteristics (Lifestyle, psychosocial factors, past experience and expectations of physiotherapy). 3) Shoulder symptoms and general health. Page: 3 / 7

4 4) Signs of impairment from the objective/clinical examination. 5) Activity and participation. 6) Radiological imaging. 1) Collection of any potential prognostic factor(s) after the first physiotherapy appointment. 2) Blood tests. 3) Surgical or arthroscopic findings. Context Physiotherapy management of musculoskeletal shoulder pain in any primary, secondary or private healthcare setting, worldwide. Outcome(s) Primary outcomes 1) Pain (any dichotomous, categorical or continuous measurement validated on a group of patients with musculoskeletal pain). 2) Functional/disability scores measured by self administered validated questionnaires (any dichotomous, categorical or continuous measurement validated on a group of patients with musculoskeletal pain). 3) Minor and serious adverse events. Times at which outcomes are measured: 4-8 weeks, 9-16 weeks, 5-8 months, 9-12 months, months, 1 year and 2 years+ after starting physiotherapy. For any study, the latest point within each time category will be entered for analysis. Secondary outcomes 1) Constant score (Constant and Murley 1987). 2) Quality of life scores (any dichotomous, categorical or continuous measurement validated on a group of patients with musculoskeletal pain). 3) Return to work/days off work. 4) Range of shoulder movement (passive or active physiological). 5) Shoulder strength. Times at which outcomes are measured: 4-8 weeks, 9-16 weeks, 5-8 months, 9-12 months, months and 2 years+ after starting physiotherapy. For any study, the latest point within each time category will be entered for analysis. Data extraction, (selection and coding) Selection of records for review: 1) The first reviewer (RC) will download all retrieved records onto reference manager software (Endnote). Files will be labelled by the database from which they were retrieved and organised by author last name. Duplicates will not be removed so that the number of unique references from each database can be assessed to inform similar reviews in the future. 2) All retrieved titles +/- abstracts will be screened for full text review by the first reviewer against the set inclusion/exclusion criteria. A minimal of 30% will be screened by another independent reveiwer. Page: 4 / 7

5 3) All retrieved full text articles will be reviewed by two independent reviewers. Reasons for inclusion/exclusion will be documented in tabulated form and presented as an appendix. 4) Recording how each article meets specific inclusion/exclusion criteria also aids focussed discussion where any disagreements arise. 5) When disagreement about eligibility arises as a result of poor clarity of information, and cannot be resolved via consensus, original authors will be contacted for further details. 6) Where disagreement about eligibility arises for other reasons, which cannot be resolved by consensus or assistance of a third member, the whole team will discuss. 7) Data for each included study will be entered onto a custom designed standardised data extraction form by two independent reviewers. Any areas of disagreement will be discussed and the original authors contacted if these arise as a result of poor clarity of information. 8) Where disagreement arises for other reasons, which cannot be resolved by consensus or assistance of a third member, the whole team will discuss. This may result in documenting standard operating procedures for areas of ambiguity. Risk of bias (quality) assessment As a variety of study designs will be included in this review, no study specific quality assessment tool is suitable. Because prognostic factors are the key question in this review, assessment of study quality and risk of bias will be founded on the Guidelines for assessing quality in prognostic studies on the basis of framework for potential biases (Hayden et al 2006). The Newcastle Ottowa Score (Wells et al 2009) for non randomized studies will be utilized and supplemented by appropriate items from Hayden s guidelines (2006), relevant PEDro items (Verhagen et al 1998) and additional clinical items which may be likely sources of bias. Because of heterogeneity on a number of levels, each item which may be a source of bias will be tabulated to allow comparison between all included studies. Should homogeneity of some studies (including clinical aspects) allow meta-analysis, sensitivity analysis will be performed. In the more likely event of considerable heterogeneity, results for each individual or group of prognostic factors will be presented in tabular form, with higher quality studies with high adherence/compliance rates at the top of the table. When the protocol or methods section of included studies state that specific prognostic factors will be assessed but these are not reported in the results section, the first reviewer will write to corresponding authors for further details. Factors assessed but not reported will be tabulated for each study. Strategy for data synthesis Primarily a narrative synthesis. Meta-analysis of odds ratios or correlation coefficients if feasible, with testing for small study bias. If prognostic data cannot be pooled formally for data analysis, tables will be presented for: a) individual prognostic factors and b) groups of similar prognostic factors. Simple tick boxes for a positive, negative and no statistically significant correlation (or difference) with outcome will be presented together with correlation coefficients (or effect estimates), 95% confidence intervals and level of statistical significance. For each study entry, text within the table will detail factors that have been adjusted for in the Page: 5 / 7

6 analysis. Where more than one analysis is presented in the published article the most adjusted analysis will be documented. Analysis of subgroups or subsets Subgroup analysis will take place for: 1) Different types of shoulder pain. 2) Different types and combinations of physiotherapy treatments. 3) Outcome periods (4-8 weeks, 9-16 weeks, 5-8 months, 9-12 months, months and 2 years+ after starting physiotherapy) Dissemination plans This review will be documented according to PRISMA guidelines (Preferred reporting items for systematic reviews and meta-analysis) (Liberati et al 2009) and published as a chapter within a Doctoral thesis. On completion of the review it will be submitted for publication in a peer reviewed scientific journal. Contact details for further information Rachel Chester School of Rehabilitation Sciences Faculty of Medicine and Health Sciences University of East Anglia Norwich Norfolk, NR4 7TJ r.chester@uea.ac.uk Organisational affiliation of the review University of East Anglia Review team Ms Rachel Chester, University of East Anglia Dr Christina Jerosch-Herold, University of East Anglia Professor Lee Shepstone, University of East Anglia Professor Jeremy Lewis, Chelsea and Westminster Hospital NHS Foundation Trust Mr David Sweeting, Great Yarmouth and Waverney NHS Community Services Miss Helena Daniels, Norfolk and Norwich University Hospitals NHS Foundation Trust Anticipated or actual start date 05 January 2012 Anticipated completion date 28 February 2013 Funding sources/sponsors The lead author (RC) is funded by a National Institute of Health (NIHR) Clinical Doctoral Research Fellowship. Conflicts of interest Page: 6 / 7

7 Powered by TCPDF ( None known Language English Country England Subject index terms status Subject indexing assigned by CRD Subject index terms Humans; Physical Therapy Modalities; Prognosis; Range of Motion, Articular; Shoulder Pain; Treatment Outcome; Stage of review Completed and published Date of registration in PROSPERO 21 December 2011 Date of publication of this revision 31 January 2014 Details of final report/publication(s) Rachel Chester, Lee Shepstone, Helena Daniell, David Sweeting, Jeremy Lewis, Christina Jerosch-Herold. Predicting response to physiotherapy treatment for musculoskeletal shoulder pain: a systematic review. BMC Musculoskeletal Disorders 2013, 14: DOI /CRD Stage of review at time of this submission Started Completed Preliminary searches Yes Yes Piloting of the study selection process Yes Yes Formal screening of search results against eligibility criteria Yes Yes Data extraction Yes Yes Risk of bias (quality) assessment Yes Yes Data analysis Yes Yes PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 7 / 7