Condition category
Musculoskeletal Diseases
Date applied
22/06/2006
Date assigned
04/10/2006
Last edited
18/02/2010
Prospective/Retrospective
Retrospectively 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 Hugh MacPherson

ORCID ID

Contact details

Department of Health Sciences
Seebohm Rowntree Area 3
Heslington
York
YO10 5DD
United Kingdom
hm18@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

AOK

Study hypothesis

That a full-scale randomised controlled trial is feasible, and that the design can be optimised on the basis of the pilot

Ethics approval

York Local Research Ethics Committee (reference no.:06/Q1108/30), approval received on 09/06/2006.

Study design

A pilot for a randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis of the knee

Intervention

Group one: acupuncture plus usual General Practitioner (GP) care
Group two: usual GP care alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The impact of acupuncture on osteoarthritis of the knee will be measured using the WOMAC™ knee and hip osteoarthritis index, the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Oxford knee score

Secondary outcome measures

Quality of life will be assessed using the EuroQOL 5D Instrument (EQ-5D)

Overall trial start date

01/07/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients over 50 years old who have consulted in primary care with a diagnosis of osteoarthritis of the knee and are experiencing ongoing pain and stiffness in the knee

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Currently receiving acupuncture
2. Pending litigation related to the knee
3. Under cancer care review
4. Haemophilia
5. Rheumatoid arthritis
6. Total knee or hip surgery on the affected side

Recruitment start date

01/07/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Sciences
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Research Support Office
Heslington
York
YO10 5DD
United Kingdom
smf3@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk/research

Funders

Funder type

Research council

Funder name

Medical Research Council Health Services Research Collaboration, Research Initiative Grant (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19852841

Publication citations

  1. Results

    Lansdown H, Howard K, Brealey S, MacPherson H, Acupuncture for pain and osteoarthritis of the knee: a pilot study for an open parallel-arm randomised controlled trial., BMC Musculoskelet Disord, 2009, 10, 130, doi: 10.1186/1471-2474-10-130.

Additional files

Editorial Notes