Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder

NCT03300297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-18

No results posted yet for this study

Summary

Background: Temporomandibular disorder (TMD) is a common and costly problem that often leads to chronic pain or dysfunction. There is moderate evidence to support physical therapy (PT) interventions for individuals with TMD, yet they continue to be an underserved population. A known relationship between TMD and the cervical spine exists with some evidence to support the use of cervical interventions for TMD. Cervical spine thrust joint manipulation (TJM) is an effective PT intervention that has been explored in a limited fashion for this population.

The purpose of this trial is to determine the immediate and short term (1 and 4 week) effects of cervical TJM delivered by a physical therapist on pain, dysfunction, and perception of change in persons with a primary complaint of TMD. The hypothesis is that all participants will improve, and those in the cervical TJM group may have a greater degree of improvement.

Design: Participants will be randomized to one of two groups and all will receive physical therapy. Forty-two willing participants, age 18-65 with TMD will complete the informed consent process and screening for eligibility before being admitted. Participants will receive a combined treatment of 1) behavioral education, a home exercise program, soft tissue mobilization, and cervical spine TJM or 2) behavioral education, a home exercise program, soft tissue mobilization, and sham manipulation. Participants will receive 4 treatments over a period of 4 weeks.

Significance: The results of this clinical trial will provide evidence relative to the impact of cervical spine TJM in the treatment of persons with TMD. Determining the effectiveness of cervical spine TJM included with a combined treatment approach has clinical implication for physical therapists and the patients they serve.

Conditions

  • Temporomandibular Disorder

Interventions

OTHER

Cervical Spine Thrust Joint Manipulation

High velocity, short amplitude thrust to the cervical spine

OTHER

Cervical Spine Sham Manipulation

Manipulative hold position shy of end range without a thrust

OTHER

Home Program

therapeutic exercise program and education

OTHER

Suboccipital Release

suboccipital soft tissue mobilization

Sponsors & Collaborators

  • Nova Southeastern University

    collaborator OTHER
  • University of Nevada, Las Vegas

    collaborator OTHER
  • Bradley University

    lead OTHER

Principal Investigators

  • Breanna C Reynolds, DPT · Bradley University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2018-10-02
Completion
2018-12-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03300297 on ClinicalTrials.gov