|
ISRCTN
|
ISRCTN61111416
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Acupuncture and pain relief in temporomandibular joint dysfunction syndrome
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0059108302
|
|
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.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Ethics approval received from the local medical ethics committee
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Oral Health: Oral Medicine
|
|
Participants - inclusion criteria
|
120 patients suffering with temporomandibular joint dysfunction.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/02/2002
|
|
Anticipated end date
|
01/10/2003
|
|
Status of trial
|
Stopped |
|
Patient information material
|
|
|
Target number of participants
|
120
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Sheffield Teaching Hospitals (Central Campus) (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Alison
Loescher
|
|
Address
|
University of Sheffield
Oral & Maxillofacial Surgery
Charles Clifford Dental Hospital
|
|
City/town
|
Sheffield
|
|
Zip/Postcode
|
S10 2SZ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 0114 271 7811
|
|
Fax
|
+44 0114 271 1901
|
|
Email
|
a.loescher@shef.ac.uk
|
|
Sponsor
|
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)207 307 2622
|
|
Fax
|
+44 (0)207 307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
12/09/2003
|
|
Last edited
|
19/10/2011
|
|
Date ISRCTN assigned
|
12/09/2003
|