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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
MSc Dissertation only