Condition category
Musculoskeletal Diseases
Date applied
11/08/2009
Date assigned
02/10/2009
Last edited
04/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Beresford

ORCID ID

Contact details

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

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 Children’s 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

http://www.alderhey.com

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

  1. 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.

Additional files

Editorial Notes