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
Protocol serial number	H0640
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at six months.
Key secondary outcome measure(s)	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
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Department of Rheumatology

Stoke-on-Trent
ST6 7AG
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2007		Yes	No
Protocol article	protocol	02/09/2004		Yes	No

Editorial Notes

11/01/2018: internal review