Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder

February 14, 2019 updated by: Breanna Reynolds, Bradley University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: Research design following CONSORT guidelines. A blinded assessor will measure ROM and PPT. Treating therapists will know group allocation and will receive training to standardize assessments and treatments. Self-report and objective measurements will be taken at baseline, immediately after treatment one, and at one and four week follow-ups.

Data Analysis (primary): Sample size estimations were completed using G-Power, a free online downloadable program. An F-test family with ANOVA: Repeated measures, within-between interaction protocol was selected. While it is optimal to power sample size estimations around a functional outcome measure, the limited use of functional measures in this population created an obstacle. The sample size estimation for this project was powered around maximal mouth opening (MMO) as this most closely relates to function in the TMD population. In order to account for 15% attrition, and maintain equal participants in each arm of this study, the desired sample size is 42 participants.

A 2 x 4 mixed model analysis of variance (ANOVA) will be used with treatment group as the between-subjects factor and time as the within-subjects factor. Separate ANOVAs will be performed for dependent variables and the hypothesis of interest will be group by time interaction for each ANOVA.

To determine if missing data points associated with dropouts were missing at random or missing for systematic reasons, we will perform Little's Missing Completely at Random (MCAR) Test. Intention to treat analysis will be performed by using expectation maximization whereby missing data are computed using regression equations. Planned pair-wise comparisons will examine the difference between baseline and follow-up periods using the Bonferroni equality at an alpha level of 0.05.

Success will be dichotomized using the GROC scale. A cut-off score of +5 or higher on the GROC will be used as a measure of success. Correlations between outcome measures (change scores) and success will be analyzed using an independent t-test to determine if differences between groups exist. Number needed to treat (NNT) will be calculated. Correlations among dependent variables will be analyzed with Pearson/Spearman correlations. Examples include the following: correlation between NDI and jaw functional measures, correlation among PPT at various areas tested, and correlation between change in ROM and change in functional scores. Data analysis will include 95% confidence intervals, and tables, charts, or other figures will be utilized to display findings to enhance reader understanding. Effect size of primary outcome measures including jaw ROM, JFLS, and TMD Disability Index will be calculated and reported. If there is no significant difference between groups noted, a post-hoc power analysis will be performed to determine the risk of Type II error.

Data Safety Plan/Subject Confidentiality: The PI will be responsible for educating all clinicians, research assistants, and front office staff with RVPT, Bradley University, and UNLV in confidentiality measures and data safety plans. This information will be part of the live training and included in the Manuals of Standard Operating Procedures. The PI will also periodically check in with each participating clinician, blinded assessor, and clinic office staff member to review procedures and monitor recruitment and retention. This check will occur once per month over the phone.

Standard Operating Procedures: Manual developed and used in training.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Rock Valley Physical Therapy
      • Washington, Illinois, United States, 61571
        • Rock Valley Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 y/o
  • primary complaint of TMD pain
  • positive TMD screen
  • proficiency in English language
  • availability to attend 4 sessions
  • minimum level of disability (NPRS 2 or greater)
  • minimum level of disability (pain free mouth opening 50 mm or less).

Exclusion Criteria:

  • traumatic onset of symptoms
  • whiplash in the last 6 weeks
  • prior neck surgery
  • medical red flags suggestive on on-musculoskeletal origin of pain, systemic disease, or neurological disease
  • contraindications to thrust joint manipulation (TJM),
  • previous TJM in the last 3 months
  • Worker's compensation
  • pending litigation regarding pain or injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cervical Spine Thrust Joint Manipulation
Thrust Manipulation delivered to C0/1 and C2/3 on both the right and left side
Other: Cervical Spine Thrust Joint Manipulation
High velocity, short amplitude thrust to the cervical spine
Other Names:
  • Grade V manipulation
Other: Home Program
therapeutic exercise program and education
Other: Suboccipital Release
suboccipital soft tissue mobilization
Other Names:
  • soft tissue mobilization
Sham Comparator: Cervical Spine Sham Manipulation
Sham Manipulation delivered to C0/1 and C2/3 on both the right and left side
Other: Home Program
therapeutic exercise program and education
Other: Suboccipital Release
suboccipital soft tissue mobilization
Other Names:
  • soft tissue mobilization
Other: Cervical Spine Sham Manipulation
Manipulative hold position shy of end range without a thrust

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maximal Mouth Opening Range of Motion (mm)
Time Frame: baseline, immediate, 1 week, 4 week
Jaw ROM, mouth opening
baseline, immediate, 1 week, 4 week
Change in Pain with Numeric Pain Rating Scale
Time Frame: baseline, immediate, 1 week, 4 week
NPRS, self-reported intensity of pain on 0-10 pain rating scale
baseline, immediate, 1 week, 4 week
Change in Function with Jaw Functional Limitation Scale
Time Frame: baseline, 1 week, 4 week, 3 month, 6 month
JFLS, self report jaw functions rated 0-10 based on difficulty
baseline, 1 week, 4 week, 3 month, 6 month
Change in Fear with Tampa Scale of Kinesiophobia-TMD version
Time Frame: baseline, 1 week, 4 week, 3 month, 6 month
self report scale to assess level of fear rating 12 items on a 1-4 scale
baseline, 1 week, 4 week, 3 month, 6 month
Global Rating of Change
Time Frame: immediate, 1 week, 4 week
perception of overall change in a self report scale from -7 to +7
immediate, 1 week, 4 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Function with Neck Disability Index
Time Frame: baseline, 1 week, 4 week, 3 month, 6 month
10 item self report assessment of neck disability
baseline, 1 week, 4 week, 3 month, 6 month
Change in Function with TMD Disability Index
Time Frame: baseline, 1 week, 4 week, 3 month, 6 month
10 item self report assessment of jaw dysfunction
baseline, 1 week, 4 week, 3 month, 6 month
Patient Acceptable Symptom State
Time Frame: 4 week, 3 month, 6 month
Self report acceptable nature of current state
4 week, 3 month, 6 month
Change in Cervical Spine range of motion
Time Frame: baseline, immediate, 1 week, 4 week
bubble inclinometer measurement of neck motion
baseline, immediate, 1 week, 4 week
Change in Pain pressure threshold
Time Frame: baseline, immediate, 1 week, 4 week
digital algometer assessment of threshold
baseline, immediate, 1 week, 4 week
PHQ-2 Depression Screen
Time Frame: baseline
2 question screen
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bradley University

Collaborators

University of Nevada, Las Vegas
Nova Southeastern University

Investigators

  • Principal Investigator: Breanna C Reynolds, DPT, Bradley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2017

Primary Completion (Actual)

October 2, 2018

Study Completion (Actual)

December 6, 2018

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU 59-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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