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

Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom

Phone +44 (0)1782 715444
Email e.m.hay@cphc.keele.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleIntegrated care in practice: Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain?
Study objectivesTo 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) studiedKnee pain
InterventionAcupuncture plus advice and exercise versus placebo acupuncture plus advice and exercise advice versus exercise alone.
Intervention typeOther
Primary outcome measureChange in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at six months.
Secondary outcome measures1. 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 date01/11/2003
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants350
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2003
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Rheumatology
Stoke-on-Trent
ST6 7AG
United Kingdom

Sponsor information

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Email info@arc.org.uk
Website http://www.arc.org.uk
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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