Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs

NCT ID: NCT02637544

Last Updated: 2016-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Temporomandibular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type OTHER

classical acupuncture therapy

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.

Group Type PLACEBO_COMPARATOR

acupuncture

Intervention Type OTHER

classical acupuncture therapy

Interventions

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acupuncture

classical acupuncture therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Heidelberg Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sinan Sen

Dr. med. dent.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinan Sen, Dr.med.dent.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthodontics, University of Heidelberg

Locations

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Poliklinik für Hals-Nasen-Ohrenheilkunde

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Nikolaos Giannakopoulos, Dr.med.dent.

Role: CONTACT

+491737373129

Facility Contacts

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Serkan Sertel, PD Dr. med.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 10812251 (View on PubMed)

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.

Reference Type RESULT
PMID: 1298767 (View on PubMed)

Other Identifiers

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S-099/2014

Identifier Type: -

Identifier Source: org_study_id

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