Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder
NCT03300297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-02-18
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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