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 |
| Secondary identifying numbers | HTA 94/39/14 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/06/1998 |
| Completion date | 28/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
WarwickEmergency Care & Rehabilitation
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
