Acupuncture and pain relief in temporomandibular joint dysfunction syndrome

ISRCTN	ISRCTN61111416
DOI	https://doi.org/10.1186/ISRCTN61111416
Secondary identifying numbers	N0059108302

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 19/10/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alison Loescher
Scientific

University of Sheffield
Oral & Maxillofacial Surgery
Charles Clifford Dental Hospital
Sheffield
S10 2SZ
United Kingdom

Phone	+44 0114 271 7811
Email	a.loescher@shef.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/02/2002
Completion date	01/10/2003
Reason abandoned (if study stopped)	Lack of funding

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	120
Key inclusion criteria	120 patients suffering with temporomandibular joint dysfunction.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/2002
Date of final enrolment	01/10/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Sheffield

Sheffield
S10 2SZ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Sheffield Teaching Hospitals (Central Campus) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan