Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anne McMillan

ORCID ID

Contact details

University of Newcastle
Dept of Restorative Dentistry
Dental School
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom
+44 (0)191 2228196

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

1997 results in http://www.ncbi.nlm.nih.gov/pubmed/9656906

Publication citations

  1. 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.

Additional files

Editorial Notes