search
Back to results

Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs

Primary Purpose

Temporomandibular Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
acupuncture
Sponsored by
University of Heidelberg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Poliklinik für Hals-Nasen-OhrenheilkundeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Verum

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

current pain measured on Numerical Rating Scale

Secondary Outcome Measures

maximum unassisted jaw opening in mm

Full Information

First Posted
October 1, 2015
Last Updated
February 2, 2016
Sponsor
University of Heidelberg Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02637544
Brief Title
Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs
Official Title
Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Heidelberg Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified TMDs.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
classical acupuncture therapy
Primary Outcome Measure Information:
Title
current pain measured on Numerical Rating Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
maximum unassisted jaw opening in mm
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikolaos Giannakopoulos, Dr.med.dent.
Phone
+491737373129
Email
nik.giannakopoulos@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinan Sen, Dr.med.dent.
Organizational Affiliation
Department of Orthodontics, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poliklinik für Hals-Nasen-Ohrenheilkunde
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serkan Sertel, PD Dr. med.
Email
serkan.sertel@med.uni-heidelberg.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
10812251
Citation
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.
Results Reference
background
PubMed Identifier
1298767
Citation
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.
Results Reference
result

Learn more about this trial

Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs

We'll reach out to this number within 24 hrs