Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs
February 2, 2016 updated by: Sinan Sen, University of Heidelberg Medical Center
Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie
Aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified TMDs.
Study Overview
Detailed Description
Therefore there are two treatment arms, acupuncture verum and acupuncture placebo.
Investigators will evaluate for 4 weeks primary current pain, secondary the unassisted jaw opening.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Heidelberg, Germany, 69120
- Recruiting
- Poliklinik für Hals-Nasen-Ohrenheilkunde
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Contact:
- Serkan Sertel, PD Dr. med.
- Email: serkan.sertel@med.uni-heidelberg.de
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- non chronified TMD pain
- written informed consent
Exclusion Criteria:
- dysfunctional TMD pain
- systematic diseases affecting the joints or pain perception
- pregnancy
- needle phobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Verum
Acupuncture therapy. For this study arm following acupuncture points suitable for facial pain, according to traditional chinese medicine, were chosen: F2, F3, F34, IT3, IT19, S7, T21 and temporomandibular joint ear acupuncture points. Only intervention is the acupuncture therapy. |
classical acupuncture therapy
|
|
Placebo Comparator: Placebo
Placebo acupuncture therapy.
For this study arm points outside of the meridians according to traditional chinese medicine, were chosen.
Only intervention is the acupuncture therapy.
|
classical acupuncture therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
current pain measured on Numerical Rating Scale
Time Frame: 4 weeks
|
4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
maximum unassisted jaw opening in mm
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sinan Sen, Dr.med.dent., Department of Orthodontics, University of Heidelberg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.
- Ezzo J, Berman B, Hadhazy VA, Jadad AR, Lao L, Singh BB. Is acupuncture effective for the treatment of chronic pain? A systematic review. Pain. 2000 Jun;86(3):217-225. doi: 10.1016/S0304-3959(99)00304-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
October 1, 2015
First Submitted That Met QC Criteria
December 21, 2015
First Posted (Estimate)
December 22, 2015
Study Record Updates
Last Update Posted (Estimate)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-099/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.