A randomised controlled trial of intensive physiotherapy vs a home-based exercise treatment programme in knee osteoarthritis
| ISRCTN | ISRCTN86233347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86233347 |
| Protocol serial number | HTA 94/39/14 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 01/04/2022
- 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
Mr Chris McCarthy
Scientific
Scientific
WarwickEmergency Care & Rehabilitation
Warwick University
Warwick Medical School
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)2476 575856 |
|---|---|
| c.j.mccarthy@warwick.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised controlled trial of intensive physiotherapy vs a home-based exercise treatment programme in knee osteoarthritis |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Pain relief |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 28/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 214 |
| Total final enrolment | 214 |
| Key inclusion criteria | New referrals from primary care with diagnosis of osteoarthritis according to standard criteria. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/06/1998 |
| Date of final enrolment | 28/02/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
WarwickEmergency Care & Rehabilitation
Coventry
CV4 7AL
United Kingdom
CV4 7AL
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2004 | Yes | No |
Editorial Notes
01/04/2022: The following changes have been made:
1. Publication reference reclassified as results.
2. The final enrolment number has been added from the reference.
