Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
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

Mr Chris McCarthy

ORCID ID

Contact details

WarwickEmergency Care & Rehabilitation
Warwick University
Warwick Medical School
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 575856
c.j.mccarthy@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 94/39/14

Study information

Scientific title

Acronym

Study hypothesis

The objective of the study is to determine whether an intensive regime of physiotherapy is superior to a home-based exercise programme in relation to the following key outcomes: (1) pain relief, (2) improvement in function, (3) improvement in quality of life, (4) prolongation of the period before surgical intervention is thought indicated. Eligible patients, who will be recruited from participating orthopaedic and rheumatology clinics, will be new referrals from primary care with diagnosis of osteoarthritis according to standard criteria. 180 patients will be recruited and randomised either to active physiotherapy or a home-based exercise teaching programme. All subjects, where appropriate, will be given advice on weight reduction and simple analgesics.
Outcome will be assessed at eight weeks, six months, and one year.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal diseases: Arthritis (osteo)

Intervention

Please note that, as of 17 January 2008, the start and end date of this trial were updated from 1 February 1998 and 31 January 2001 to 1 June 1998 and 28 February 2002, respectively.

Interventions:
1 Active physiotherapy
2. Home-based exercise teaching programme.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Pain relief
2. Improvement in function
3. Improvement in quality of life
4. Prolongation of the period before surgical intervention is thought indicated

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/06/1998

Overall trial end date

28/02/2002

Reason abandoned

Eligibility

Participant inclusion criteria

New referrals from primary care with diagnosis of osteoarthritis according to standard criteria.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

214

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/06/1998

Recruitment end date

28/02/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

WarwickEmergency Care & Rehabilitation
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

2004 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15527668

Publication citations

  1. HTA monograph

    McCarthy CJ, Mills PM, Pullen R, Richardson G, Hawkins N, Roberts CR, Silman AJ, Oldham JA, Supplementation of a home-based exercise programme with a class-based programme for people with osteoarthritis of the knees: a randomised controlled trial and health economic analysis., Health Technol Assess, 2004, 8, 46, iii-iv, 1-61.

Additional files

Editorial Notes