Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
94099926 r280/05109
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
randomised double blind controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Oral health/stomatognathic diseases
Intervention
1. Acupuncture
2. Local anaesthetic injection
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
03/01/1995
Overall trial end date
31/12/1996
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients presenting with myofascial pain in the jaw muscles
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Added December 2008: 30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
03/01/1995
Recruitment end date
31/12/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Newcastle
Newcastle upon Tyne
NE2 4BW
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (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
Basic results (scientific)
Publication list
1997 results in http://www.ncbi.nlm.nih.gov/pubmed/9656906
Publication citations
-
Results
McMillan AS, Nolan A, Kelly PJ, The efficacy of dry needling and procaine in the treatment of myofascial pain in the jaw muscles., J Orofac Pain, 1997, 11, 4, 307-314.