Contact information
Type
Scientific
Primary contact
Dr EM Hay
ORCID ID
Contact details
Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom
+44 (0)1782 715444
e.m.hay@cphc.keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
H0640
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Knee pain
Intervention
Acupuncture plus advice and exercise versus placebo acupuncture plus advice and exercise advice versus exercise alone.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/11/2003
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
350
Participant 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
Recruitment start date
01/11/2003
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Rheumatology
Stoke-on-Trent
ST6 7AG
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Protocol in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15345098
Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17699546
Publication citations
-
Protocol
Hay E, Barlas P, Foster N, Hill J, Thomas E, Young J, Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain?: the "acupuncture, physiotherapy and exercise" (APEX) study [ISRCTN88597683]., BMC Musculoskelet Disord, 2004, 5, 31, doi: 10.1186/1471-2474-5-31.
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Results
Foster NE, Thomas E, Barlas P, Hill JC, Young J, Mason E, Hay EM, Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial., BMJ, 2007, 335, 7617, 436, doi: 10.1136/bmj.39280.509803.BE.