Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
04/06/2009
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 RW Jubb

ORCID ID

Contact details

Rheumatology
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265041788

Study information

Scientific title

Acronym

Study hypothesis

In an open study, can acupuncture be shown to have an analgesic effect for patients with osteoarthritis of the knee?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Knee osteoarthritis

Intervention

Open pilot study looking at patients who have osteoarthritis of their knee and whose pain is not well-controlled on conventional treatment. The patients would be asked to take part for a period of 5 weeks. Possible patients must be over 18 years of age, not women of child-bearing age, not patients with pacemakers fitted. Patients will be randomised into one of three groups:
1. Patients receiving acupuncture alone
2. Patients receiving acupuncture as well as their conventional therapy
3. Patients continuing on their conventional therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Patients Global Assessment of Efficacy
2. Investigator Global Assessment of Efficacy
3. 100m Visual Analogue Scale for Pain Assessment
4. WOMAC Index
5. Kellgren & Lawrence Scale for radiological assessment of osteoarthritis

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

This is a pilot study - the size of any effect not known. Volunteers will be recruited from the rheumatology outpatients clinics at Selly Oak Hospital. We anticipate about 10 patients per group will be sufficient to enable a power calculation to be made. They must have osteoarthritis of the knee, and find that their pain is not well controlled by conventional medicine. They must be over 18 years of age.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

Patients will be excluded if they have any of the following: rheumatoid arthritis, Gout, psoriatic arthritis, osteoarthritis of the hip, patients with pacemakers fitted, patients with known metal allergies, patients with an history of prosthetic or damaged valves, patients with hemophilia, patients taking an anticoagulant or oral corticosteroid, patients suffering with dementia or other psychiatric disease, patients with Grade I or IV on the Kellgren & Lawrence scale, patients with uncontrolled diabetes and patients with a skin disease likely to affect the use of the acupuncture needles.

Recruitment start date

01/07/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology
Birmingham
B29 6JD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15077933

Publication citations

  1. Results

    Tukmachi E, Jubb R, Dempsey E, Jones P, The effect of acupuncture on the symptoms of knee osteoarthritis--an open randomised controlled study., Acupunct Med, 2004, 22, 1, 14-22.

Additional files

Editorial Notes