Integrated care in practice: Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain?
| ISRCTN | ISRCTN88597683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88597683 |
| Secondary identifying numbers | H0640 |
- Submission date
- 03/01/2003
- Registration date
- 03/01/2003
- Last edited
- 11/01/2018
- 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 EM Hay
Scientific
Scientific
Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom
| Phone | +44 (0)1782 715444 |
|---|---|
| e.m.hay@cphc.keele.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 | Treatment |
| Scientific title | Integrated care in practice: Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain? |
| Study objectives | To investigate whether acupuncture is a useful adjunct to advice and exercise for treating knee pain and gain insight into whether this effect is due to specific needling properties: 1. We will determine the additional benefit of true acupuncture when used by physiotherapists alongside advice and exercise for older people presenting to primary care with knee pain 2. We will evaluate sham acupuncture in the same way 3. We will investigate the treatment preferences and expectations of both the participants and physiotherapists participating in the study, and explore the effect of these on clinical outcome |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Knee pain |
| Intervention | Acupuncture plus advice and exercise versus placebo acupuncture plus advice and exercise advice versus exercise alone. |
| Intervention type | Other |
| Primary outcome measure | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at six months. |
| Secondary outcome measures | 1. Knee-related pain 2. Movement and function 3. Pain intensity and effect 4. Main functional problem 5. Illness perceptions 6. Self-efficacy 7. Treatment preference and expectations 8. General health and quality of life |
| Overall study start date | 01/11/2003 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 350 |
| Key inclusion criteria | 1. Male and female subjects aged 50 years and above 2. Pain with or without stiffness in one or both knees 3. Naive to acupuncture treatment (i.e., have never experienced acupuncture before for their present or any past complaints) 4. Considered suitable for referral to physiotherapy outpatients department 5. Able to read and write English, and to give full informed consent 6. Willing to consent to participation 7. Available for telephone contact |
| Key exclusion criteria | 1. Potentially serious pathology (e.g. inflammatory arthritis, malignancy etc) on the basis of general practice or physiotherapy diagnosis or from past medical history 2. Have had a knee or hip replacement on the affected side(s) 3. Are already on a surgical waiting list for total knee replacement 4. Trial interventions are contraindicated 5. Have received an exercise programme, from a physiotherapist, for their knee problem within the last three months (normal recreational involvement in sport or exercise will not be an exclusion) 6. Received an intra-articular injection to the knee in the last six months |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Rheumatology
Stoke-on-Trent
ST6 7AG
United Kingdom
ST6 7AG
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
| info@arc.org.uk | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/09/2004 | Yes | No | |
| Results article | results | 01/09/2007 | Yes | No |
Editorial Notes
11/01/2018: internal review
