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Integrated care in practice: Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain?
ISRCTN ISRCTN88597683
DOI 10.1186/ISRCTN88597683
ClinicalTrials.gov identifier
EudraCT number
Public title Integrated care in practice: Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain?
Scientific title
Acronym N/A
Serial number at source H0640
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
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Knee pain
Participants - 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
Participants - 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
Anticipated start date 01/11/2003
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material
Target number of participants 350
Interventions Acupuncture plus advice and exercise versus placebo acupuncture plus advice and exercise advice versus exercise alone.
Primary outcome measure(s) Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at six months.
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
Sources of funding Arthritis Research Campaign (UK)
Trial website
Publications 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
Contact name Dr  EM  Hay
  Address Department of Rheumatology
Haywood Hospital
High Lane
Burslem
  City/town Stoke-on-Trent
  Zip/Postcode ST6 7AG
  Country United Kingdom
  Tel +44 (0)1782 715444
  Email e.m.hay@cphc.keele.ac.uk
Sponsor Arthritis Research Campaign (ARC) (UK)
  Address Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
  City/town Derbyshire
  Zip/Postcode S41 7TD
  Country United Kingdom
  Email info@arc.org.uk
  Sponsor website: http://www.arc.org.uk
Date applied 03/01/2003
Last edited 21/08/2007
Date ISRCTN assigned 03/01/2003
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