Generalised versus targeted physiotherapy in childhood hypermobility

ISRCTN	ISRCTN58523390
DOI	https://doi.org/10.1186/ISRCTN58523390
Protocol serial number	04/Q1502/7
Sponsor	Royal Liverpool Children's NHS Trust (UK)
Funder	Royal Liverpool Children's NHS Trust (UK) - Research and Development Department

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

Primary study design	Interventional
Study design	Randomised comparative trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised comparative trial of generalised versus targeted physiotherapy in the management of childhood hypermobility
Study acronym	The Hypermobility Trial
Study objectives	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(s)	Liverpool Childrens Local Research Ethics Committee approved on the 26th April 2004 (ref: 04/Q1502/7)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	108
Key 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.
Key exclusion criteria	Patients were excluded if they refused consent.
Date of first enrolment	01/06/2004
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Rheumatology

Liverpool
L12 2AP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes