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Complementary Medicine Approaches to TMD Pain Management

NCT ID: NCT00010621

Last Updated: 2006-08-18

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

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2004-07-31

Brief Summary

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This study will determine whether selected complementary approaches to temporomandibular joint (TMJ) pain management-acupuncture are as effective as usual care.

Detailed Description

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Temporomandibular disorders are characterized by pain and tenderness in the muscles of mastication and/or the (TMJ), limitations of jaw opening often accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds. This study will compare the effectiveness of the complementary therapies chiropractic therapy and bodywork therapy to the standard of care for TMJ pain. If these complementary interventions are shown to be effective, the goal is to design and implement a Phase III clinical trial to further evaluate the health consequences and cost of these therapies.

Participants will be evaluated at baseline, and 6 and 12 months post-intervention. Clinical examinations, saliva samples to assess salivary cortisol levels, and a series of questionnaires to assess pain and grade of dysfunctional pain, psychological functioning, and other physical symptoms will be used to assess outcomes. The investigators will passively monitor health care utilization within KPNW using clinical, research, and administrative databases.

Conditions

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Temporomandibular Joint Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Acupuncture

Intervention Type PROCEDURE

chiropractic therapy

Intervention Type PROCEDURE

bodywork therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Psychologically functional TMD patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Alex White

Role: PRINCIPAL_INVESTIGATOR

Center for Health Research (CHR), Kaiser Foundation Hospitals

Locations

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Center for Health Research

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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P50AT000076-01

Identifier Type: NIH

Identifier Source: secondary_id

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P50AT000076-01P1

Identifier Type: NIH

Identifier Source: org_study_id

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NCT00009334

Identifier Type: -

Identifier Source: nct_alias