Title: The effects of a comprehensive physiotherapy intervention for adults with joint hypermobility
Funder: Department of Health (England)

Abstract: Objective: To determine the feasibility of a single blind randomised controlled trial (RCT) to investigate the effects of a comprehensive physiotherapy intervention for adults with joint hypermobility.Design: A feasibility study in preparation for a future single blind randomised controlled trial.Setting: Physiotherapy outpatient departments.Participants: Adults (>18 years of age) referred for physiotherapy who meet the Brighton criteria for JHS. Participants will be excluded if they have other conditions causing pain or inhibiting exercise pre-existing psychological distress or psychiatric conditions or have recently received physiotherapy for JHS (one year). 60 patients will be randomised for the feasibility RCT.Interventions: A comprehensive physiotherapy intervention to include exercise education advice and supported self management will be developed as an integral part of the study. This will be compared against condition-specific advice booklets in a randomised controlled feasibility study.Main Outcome Measures: Key outcomes from the research include development of a comprehensive physiotherapy intervention and associated training materials informed by focus groups with patients and clinicians and incorporating the best available evidence (Stage 1). The intervention will then be piloted in practice and refined to ensure that it is acceptable to patients and physiotherapists (Stage 2). Important outcomes from the randomised controlled feasibility study (Stage 3) are: (a) the number of potential eligible patients with JHS; (b) the feasibility of recruitment and retention; (c) acceptability of the research design and physiotherapy intervention to patients in terms of quality of life; (d) acceptability and feasibility of the physiotherapy intervention to physiotherapists in terms of training and implementation; and (e) an estimate of the value of information (VOI) from a subsequent RCT. Finally a definitive RCT protocol will be developed to determine the clinical and cost-effectiveness of the intervention.Methodology:A single blind randomised controlled feasibility study.Sample Group:Adults (>18 years of age) referred for physiotherapy who meet the Brighton criteria for joint hypermobility syndrome (JHS). Participants will be excluded if they have other conditions causing pain or inhibiting exercise pre-existing psychological distress or psychiatric conditions or have recently received physiotherapy for JHS (one year).Outcome Measures: (As this is a feasibility study there is more emphasis on the research process rather than on the use of outcome measures to establish the effectiveness of the intervention. Key outcomes include: Early phases of the research will develop a comprehensive physiotherapy intervention and associated training materials. The intervention will be developed following focus groups with patients and clinicians (Stage 1). It will incorporate the best available evidence and will be tried out in practice and refined as necessary to ensure that it is acceptable to patients and physiotherapists (Stage 2). Important outcomes from the randomised controlled feasibility study (Stage 3) are: (a) the number of potential eligible patients with JHS; (b) the feasibility of recruitment and retention; (c) acceptability of the research design and physiotherapy intervention to patients in terms of quality of life; (d) acceptability and feasibility of the physiotherapy intervention to physiotherapists in terms of training and implementation; and (e) an estimate of the value of information (VOI) from a subsequent RCT. Finally a definitive RCT protocol will be developed to determine the clinical and cost-effectiveness of the intervention.The feasibility study will assess a number of outcomes relevant for the planned future RCT. These include physical function pain global status fatigue and self report joint count (Multidimensional Health Assessment Questionnaire); pain at rest and on movement (visual analogue scales); a new condition-specific physical function questionnaire developed by the research team; quality of life (EQ-5D); exercise self-efficacy (exercise self-efficacy scale); illness perceptions (illness perception questionnaire); resource use questionnaires; and adverse events (e.g. dislocations or other injury).


Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL