Condition category
Musculoskeletal Diseases
Date applied
31/01/2006
Date assigned
03/03/2006
Last edited
20/07/2010
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 Peter White

ORCID ID

Contact details

School of Health Professions
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
pjw1@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

170/03/t

Study information

Scientific title

Acronym

Study hypothesis

1. Acupuncture is superior to placebo for the treatment of Osteo-Arthritic (OA) hip or knee
2. Empathic approach to treatment yields superior efficacy than a non-empathic approach
3. A needle-type placebo has a greater effect than a non-needle placebo

Ethics approval

The Southampton and South West Hampshire Local Research Ethics Committee (LREC) approved on the 21st of August 2003 (ref: 170/03/t)

Study design

Randomised single blind placebo controlled multi-factorial trial with a nested qualitative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Osteoarthritis (OA)

Intervention

Patients are randomised to receive one of the following interventions:
1. Acupuncture which involves a course of treatment using a standardised but flexible choice of acupuncture points around the affected area and at distal points
2. Placebo acupuncture which involves using non-penetrating needles
3. Acupuncture-type treatment is also a placebo treatment and involves the use of a pseudo-electrical stimulation to acupuncture points via surface skin electrodes

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain measured on a VAS

Secondary outcome measures

1. Western Ontario and McMaster (WOMAC) University Osteoarthritis Index functional score
2. Nottingham Health profile

Overall trial start date

01/09/2003

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subjects aged between 18 and 80
2. Chronic or stable pain, predominantly from a single joint (hip or knee) of known mechanical aetiology i.e. osteo-arthritis
3. Score an average of 30 or more on the 100 mm visual analogue scale (VAS) in the pre-randomisation phase of the study
4. Not be on any active treatment (e.g. physiotherapy or homeopathy)
5. Ability to attend clinic twice a week for the duration of treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

288

Participant exclusion criteria

1. Pregnancy
2. Suffering serious co-morbidity (including severe back pain)
3. Prolonged or current steroid use
4. Waiting for hip/knee revision
5. Patients with needle phobia or allergy to sticking plaster

Recruitment start date

01/09/2003

Recruitment end date

01/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Health Professions
Southampton
SO17 1BJ
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Highfield
Southampton
SO17 1BJ
United Kingdom
jbk1@soton.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Department of Health (UK) - Funded Trials for Complementary Alternative Medicine (CAM) (ref: 03/12)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20433732

Publication citations

  1. Results

    Kersten P, White PJ, Tennant A, The visual analogue WOMAC 3.0 scale--internal validity and responsiveness of the VAS version., BMC Musculoskelet Disord, 2010, 11, 80, doi: 10.1186/1471-2474-11-80.

Additional files

Editorial Notes