Condition category
Musculoskeletal Diseases
Date applied
20/07/2012
Date assigned
23/07/2012
Last edited
04/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study aims to develop and test a comprehensive physiotherapy treatment package for people with joint hypermobility (these people are often described as being ‘double-jointed’). People with hypermobility have problems with many daily activities, ranging from walking to picking up small things with their fingers. Physiotherapy (including exercise, advice and education) is the main treatment but we don’t know how effective it is. This study will therefore involve the design and testing of a comprehensive physiotherapy treatment.

Who can participate?
The study will involve people over the age of 18 years who have been diagnosed with joint hypermobility syndrome and who have been referred for physiotherapy.

What does the study involve?
Early stages of the research will involve speaking with groups of patients and health care professionals about physiotherapy for joint hypermobility. The physiotherapy treatment and supporting information will be developed on the basis of these discussions. We will then train physiotherapists to deliver the treatment and it will be used with a small number of patients. We will ask patients and their physiotherapists about their experiences of the treatment and it will then be improved on the basis of that feedback. Finally, a small project will be carried out to see how easy it will be to do a much bigger study in the future. All patients will receive general advice about managing their condition in the form of booklets. These will be discussed with the physiotherapist and they will be given an opportunity to ask questions. Patients will then be randomly chosen so that half will only receive general advice and the other half will also receive the comprehensive physiotherapy treatment. Those chosen to receive physiotherapy will then have six treatments across a period of four months. All patients will complete some questionnaires at the start of the trial, at four months and again at seven months. The questionnaires will ask about their pain, beliefs about their condition, mobility, their ability to exercise, quality of life and their general health. We will also interview some patients to find out more about being part of the research, how acceptable the treatment was (should they have received this) and how acceptable the advice intervention was. The main things we want to find out are how many people could possibly take part in the research, how many did take part, and other practical information about doing the trial. All of this information will tell us whether it is worth doing a much larger trial to confirm whether physiotherapy works or not.

What are the possible benefits and risks of participating?
All patients are likely to benefit from general advice. Those receiving the physiotherapy treatment have the potential to gain additional benefit, although evidence for the effectiveness of physiotherapy has not yet been established. Potential risks may be a temporary increase in pain during or following exercise. This is likely to be similar to the normal muscle ache that people often get the day following unaccustomed activity and is likely to resolve after a few days and will improve over time as they get used to being active. What is learned from all stages of the research may help the future treatment of people with joint hypermobility.

Where is the study run from?
The study is based at North Bristol NHS Trust and also involves the Royal National Hospital for Rheumatic Diseases in Bath and researchers from the University of the West of England, Bristol University and Bath University.

When is the study starting and how long is it expected to run for?
September 2012 to June 2015

Who is funding the study?
The National Institute for Health Research, Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Shea Palmer
Shea.Palmer@uwe.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shea Palmer

ORCID ID

Contact details

Department of Allied Health Professions
Faculty of Health & Life Sciences
University of the West of England
Blackberry Hill
Bristol
BS16 1DD
United Kingdom
+44 (0)117 3288919
Shea.Palmer@uwe.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 10/98/05

Study information

Scientific title

N/A

Acronym

Study hypothesis

The study aims to:
1. Develop a comprehensive physiotherapy intervention for adults with joint hypermobility syndrome (JHS) informed by patient and clinician focus groups
2. Pilot implementation of the intervention in practice in two hospitals
3. Conduct a randomised controlled feasibility study of the intervention to determine:
3.1. The number of potential eligible patients with JHS
3.2. The feasibility of recruitment and retention
3.3. Acceptability of the research design and physiotherapy intervention to patients in terms of quality of life
3.4. Acceptability and feasibility of the physiotherapy intervention to physiotherapists in terms of training and implementation
3.5. An estimate of the value of information (VOI) from a subsequent RCT
4. Develop a final RCT protocol to determine the clinical and cost-effectiveness of the intervention

Ethics approval

Not provided at time of registration

Study design

Single-blind randomised controlled parallel-group feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Joint Hypermobility Syndrome

Intervention

Intervention:
A comprehensive physiotherapy intervention developed as part of the study (6 appointments across 4 months).

Comparator:
Condition-specific advice booklets, discussed with the physiotherapist (one-off intervention).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Stage 1: To develop a comprehensive physiotherapy intervention for adults with JHS following focus groups with patients and clinicians.
Stage 2: To pilot implementation of the intervention in practice in two hospitals.
Stage 3: To determine:
1. The number of potential eligible patients with JHS
2. The feasibility of recruitment and retention
3. Acceptability of the research design and physiotherapy intervention to patients in terms of quality of life
4. Acceptability and feasibility of the physiotherapy intervention to physiotherapists in terms of training and implementation
5. An estimate of the value of information (VOI) from a subsequent RCT

Secondary outcome measures

Stage 3: To pilot outcome measures planned for a definitive RCT. These include:
1. Physical function, pain, global status, fatigue, and self report joint count (Multidimensional Health Assessment Questionnaire)
2. Pain at rest and on movement (visual analogue scales)
3. A new condition-specific physical function questionnaire being developed by the research team
4. Health-related quality of life preference score (EQ-5D)
5. Exercise self-efficacy (exercise self-efficacy scale)
6. Illness perceptions (illness perception questionnaire)
7. Resource use questionnaires
8. Adverse events (e.g. dislocations or other injury)

Overall trial start date

01/09/2012

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. More than 18 years old
2. Able to give informed consent
3. Able to understand and communicate in English
4. Fulfil the Brighton criteria for JHS (Grahame et al 2000)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Stage 1: 32 patients, 32 clinicians; Stage 2: 10 patients; Stage 3: 60 patients

Participant exclusion criteria

1. Failure to meet the inclusion criteria
2. Other known musculoskeletal pathology causing pain, particularly osteoarthritis and inflammatory musculoskeletal disease such as rheumatoid arthritis
3. Other serious pathology including malignancy
4. Conditions affecting ability to exercise e.g. uncontrolled cardiovascular disease
5. Recent physiotherapy for JHS (within the last year)
6. Pre-existing psychological distress or psychiatric conditions.

Recruitment start date

01/09/2012

Recruitment end date

30/06/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of the West of England
Bristol
BS16 1DD
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

Research & Innovation Department
Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)117 3236468
research@nbt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nbt.nhs.uk/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27365226

Publication citations

Additional files

Editorial Notes

04/07/2016: Publication reference added.