Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
26/04/2011
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

Mrs Christine McNeil

ORCID ID

Contact details

South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 336 7433
johnchrismc@ukgateway.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226132754

Study information

Scientific title

Acronym

Study hypothesis

If the addition of acupuncture to established treatment regimes for TMPDS:
1. Enhances pain relief over the short and long term (1 year)
2. Improves patient satisfaction with treatment
3. Is a cost effective addition to treatment in the long term

It also aims to quantify the reduction in medication use: a potential cost saving to the NHS

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Temporomandibular disorder (TMD)

Intervention

1. Acupuncture combined with the usual standard regime of resting splints and physiotherapy
2. Usual standard regime of resting splints and physiotherapy alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain relief

Secondary outcome measures

No secondary outcome measures

Overall trial start date

23/01/2003

Overall trial end date

06/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

30 patients with facial pain of temporomandibular or myofacial origin from the referrals to the consultants at the Maxillofacial Clinic (Mr JR Tuffin, Mr M Patel and Mr K Sanders) and 30 controls (recruited using randomly generated numbers).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Patients who have had surgery to the TMJ/head/neck or radiotherapy
2. Contradiction to the techniques: acupuncture/severe needle phobia, uncontrolled anti-coagulation/stainless steel allergy
3. Non-consenting patients
4. Unclear diagnosis
5. Dystonic facial muscles

Recruitment start date

23/01/2003

Recruitment end date

06/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Manchester University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

MSc Dissertation only

Publication citations

Additional files

Editorial Notes