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

Status

Unknown

Conditions

Intervention / Treatment

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

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.
Other: acupuncture
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.
Other: acupuncture
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

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.

Sponsor

University of Heidelberg Medical Center

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

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.

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