Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
19/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alison Loescher

ORCID ID

Contact details

University of Sheffield
Oral & Maxillofacial Surgery
Charles Clifford Dental Hospital
Sheffield
S10 2SZ
United Kingdom
+44 0114 271 7811
a.loescher@shef.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0059108302

Study information

Scientific title

Acronym

Study hypothesis

The aim of the study is to determine if acupuncture is beneficial to patients suffering with temporomandibular dysfunction. As acupuncture is known to have a powerful placebo effect (Taub 1979, 48:205-210) it is important that the efficacy of acupuncture is determined in well controlled studies. To date there are no reported blind controlled studies to determining the efficacy of acupuncture in the management of temporomandibular joint dysfunction. In the present study comparisons will be made between the efficacy of acupuncture (intent to cure), sham acupuncture (placebo group) and traditional methods (occlusal splint) in the management of patients suffering with temporomandibular joint dysfunction.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oral Health: Oral Medicine

Intervention

Comparisons will be made between the efficacy of acupuncture (intent to cure), sham acupuncture (placebo group) and traditional methods (occlusal splint).

Added 18 July 2008: the trial did not start due to lack of funding.

Amendment Jan 2005: This trial has received ethical approval but it is not being undertaken at present due to funding issues.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2002

Overall trial end date

01/10/2003

Reason abandoned

Lack of funding

Eligibility

Participant inclusion criteria

120 patients suffering with temporomandibular joint dysfunction.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

120

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2002

Recruitment end date

01/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S10 2SZ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Sheffield Teaching Hospitals (Central Campus) (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

Publication citations

Additional files

Editorial Notes