Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/Q1502/7
Study information
Scientific title
A randomised comparative trial of generalised versus targeted physiotherapy in the management of childhood hypermobility
Acronym
The Hypermobility Trial
Study hypothesis
This 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
Liverpool Childrens Local Research Ethics Committee approved on the 26th April 2004 (ref: 04/Q1502/7)
Study design
Randomised comparative trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Symptomatic hypermobility
Intervention
Each 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Improvement 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 measures
1. 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 trial start date
01/06/2004
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
108
Participant exclusion criteria
Patients were excluded if they refused consent.
Recruitment start date
01/06/2004
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Rheumatology
Liverpool
L12 2AP
United Kingdom
Sponsor information
Organisation
Royal Liverpool Children's NHS Trust (UK)
Sponsor details
c/o Ms Dot Lambert
Research and Development Manager
Research and Development Department
Eaton Road
Liverpool
L12 2AP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Liverpool Children's NHS Trust (UK) - Research and Development Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19948753
Publication citations
-
Results
Kemp S, Roberts I, Gamble C, Wilkinson S, Davidson JE, Baildam EM, Cleary AG, McCann LJ, Beresford MW, A randomized comparative trial of generalized vs targeted physiotherapy in the management of childhood hypermobility., Rheumatology (Oxford), 2010, 49, 2, 315-325, doi: 10.1093/rheumatology/kep362.