Generalised versus targeted physiotherapy in childhood hypermobility

ISRCTN ISRCTN58523390
DOI https://doi.org/10.1186/ISRCTN58523390
Secondary identifying numbers 04/Q1502/7
Submission date
11/08/2009
Registration date
02/10/2009
Last edited
04/12/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Beresford
Scientific

Department of Rheumatology
Royal Liverpool Children's NHS Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom

Study information

Study designRandomised comparative trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised comparative trial of generalised versus targeted physiotherapy in the management of childhood hypermobility
Study acronymThe Hypermobility Trial
Study objectivesThis study aimed to compare a generalised exercise programme with a targeted programme within a randomised trial and assess the impact of these interventions on symptom scores.
Ethics approval(s)Liverpool Children’s Local Research Ethics Committee approved on the 26th April 2004 (ref: 04/Q1502/7)
Health condition(s) or problem(s) studiedSymptomatic hypermobility
InterventionEach child received six, sequential, weekly appointments for individual half-an-hour physiotherapy treatments, in which the allocated intervention was administered. Patients were randomised to a General Exercise Program or Targeted Exercise Program.
Intervention typeOther
Primary outcome measureImprovement in the child's pain assessment score. Younger children used a faces scale ranging from 1 to 5 while older children (age greater than 11 years) used a Visual Analogue Scale (VAS). Participants were asked to indicate on the linear 100 mm scale their pain level in the past week. Change in pain-VAS was used to assess the impact of therapy on symptoms. Measured at baseline (pre-treatment), midpoint (following 6-week intervention) and follow up (3 months after midpoint).
Secondary outcome measures1. Parent's assessment of their child's pain: parental-VAS
2. Parent's global evaluation of the impact of their child's hypermobility in the previous week: global-VAS
3. Functional impairment measured using the Childhood Health Assessment Questionnaire (CHAQ)
4. Six-minute shuttle test (measured at baseline and midpoint only)

Measured at baseline (pre-treatment), midpoint (following 6 week intervention) and follow up (3 months after midpoint).
Overall study start date01/06/2004
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit7 Years
Upper age limit16 Years
SexBoth
Target number of participants108
Key inclusion criteria1. Children aged 7 to 16 years, either sex
2. Treated at the Department of Rheumatology, Royal Liverpool Children's NHS Trust, Liverpool, UK between June 2004 and May 2007
3. Identified as having symptomatic hypermobility*
4. Symptomatic patients had arthralgia for three preceding months or more

*Children were hypermobile if they met Revised Criteria for benign joint hypermobility syndrome (BJHS). In brief, they had to fulfil either two major criteria, one major and two minor criteria, four minor criteria, or two minor criteria and a first degree relative with hypermobility.

Major criteria were:
1. Beighton score of greater than 4
2. Arthralgia in greater than 4 joints

Minor criteria included:
1. Beighton score less than 4
2. Arthralgia in less than 4 joints
3. Mechanical back pain for greater than 3 months
4. Hypermobility in first degree relative

Beighton score assesses hypermobility of the following: placing hands flat on floor without bending knees, hyperextension of knees and elbows greater than 100, little finger metacarpalphalangeal hyperextension to greater than 900, bending thumb to forearm.
Key exclusion criteriaPatients were excluded if they refused consent.
Date of first enrolment01/06/2004
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Rheumatology
Liverpool
L12 2AP
United Kingdom

Sponsor information

Royal Liverpool Children's NHS Trust (UK)
Hospital/treatment centre

c/o Ms Dot Lambert
Research and Development Manager
Research and Development Department
Eaton Road
Liverpool
L12 2AP
England
United Kingdom

Website http://www.alderhey.com
ROR logo "ROR" https://ror.org/00p18zw56

Funders

Funder type

Government

Royal Liverpool Children's NHS Trust (UK) - Research and Development Department

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2010 Yes No