The efficacy of acupuncture versus local anaesthetic injection in the treatment of myofascial pain in the jaw muscles.

ISRCTN	ISRCTN22866867
DOI	https://doi.org/10.1186/ISRCTN22866867
Protocol serial number	94099926 r280/05109
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Anne McMillan
Scientific

University of Newcastle
Dept of Restorative Dentistry
Dental School
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom

Phone	+44 (0)191 2228196

Primary study design	Interventional
Study design	randomised double blind controlled clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Myofascial pain is a major cause of non-dental pain in the orofacial region. Pain and tenderness at trigger points and referral sites is often treated by acupuncture and local anaesthetic injection of active trigger points. However, the therapeutic effect of these treatments has been poorly quantified and the mechanism underlying the effect is unclear. In a randomised, double blind, controlled clinical trial, a pressure algometer will be used to measure pressure-pain thresholds in the masseter and temporalis muscles of 60 subjects with myofascial pain in the jaw muscles, before and after a series of acupuncture and local anaesthetic injection treatments. Subjects will also rate pain intensity and unpleasantness using visual analogue scales. This study is designed to demonstrate the therapeutic efficacy of acupuncture versus local anaesthetic injection in the treatment of myofascial pain in the orofascial region.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oral health/stomatognathic diseases
Intervention	1. Acupuncture 2. Local anaesthetic injection
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1996

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	30
Key inclusion criteria	Patients presenting with myofascial pain in the jaw muscles
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	03/01/1995
Date of final enrolment	31/12/1996

University of Newcastle

Newcastle upon Tyne
NE2 4BW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/1997		Yes	No