CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Cervical Spine Thrust Joint Manipulation +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03300297
NCT03300297N/ACompleted

Thrust Joint Manipulation to the Cervical Spine in Participants With a Primary Complaint of Temporomandibular Disorder (TMD): A Randomized Clinical Trial

Bradley University·interventional·Posted Oct 3, 2017·Updated Feb 18, 2019

In Brief

A clinical study evaluating Cervical Spine Thrust Joint Manipulation, Cervical Spine Sham Manipulation, and 2 other interventions for Temporomandibular Disorder. Completed, enrolled 50 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 3, 2017
Enrollment StartOct 18, 2017
Primary CompletionOct 2, 2018
Study CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.7 years ago

Interventions

Cervical Spine Thrust Joint Manipulationother

High velocity, short amplitude thrust to the cervical spine

Cervical Spine Sham Manipulationother

Manipulative hold position shy of end range without a thrust

Home Programother

therapeutic exercise program and education

Suboccipital Releaseother

suboccipital soft tissue mobilization