Condition category
Musculoskeletal Diseases
Date applied
03/01/2003
Date assigned
03/01/2003
Last edited
21/08/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.arc.org.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes