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Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder

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ClinicalTrials.gov Identifier: NCT03300297
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
Nova Southeastern University
University of Nevada, Las Vegas
Information provided by (Responsible Party):
Breanna Reynolds, Bradley University

Brief 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.


Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Other: Cervical Spine Thrust Joint Manipulation Other: Cervical Spine Sham Manipulation Other: Home Program Other: Suboccipital Release Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of two intervention groups. Both will receive intervention and one group will receive cervical spine thrust joint manipulation while the other receives sham manipulation.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be blinded to group allocation. Blind assessors will be utilized to measure objective change in range of motion and pain pressure threshold.
Primary Purpose: Treatment
Official Title: Thrust Joint Manipulation to the Cervical Spine in Participants With a Primary Complaint of Temporomandibular Disorder (TMD): A Randomized Clinical Trial
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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 Name: Grade V manipulation

Other: Home Program
therapeutic exercise program and education

Other: Suboccipital Release
suboccipital soft tissue mobilization
Other Name: 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: 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
Other Name: soft tissue mobilization




Primary Outcome Measures :
  1. Change in Maximal Mouth Opening Range of Motion (mm) [ Time Frame: baseline, immediate, 1 week, 4 week ]
    Jaw ROM, mouth opening

  2. 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

  3. 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

  4. 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

  5. Global Rating of Change [ Time Frame: immediate, 1 week, 4 week ]
    perception of overall change in a self report scale from -7 to +7


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Patient Acceptable Symptom State [ Time Frame: 4 week, 3 month, 6 month ]
    Self report acceptable nature of current state

  4. Change in Cervical Spine range of motion [ Time Frame: baseline, immediate, 1 week, 4 week ]
    bubble inclinometer measurement of neck motion

  5. Change in Pain pressure threshold [ Time Frame: baseline, immediate, 1 week, 4 week ]
    digital algometer assessment of threshold

  6. PHQ-2 Depression Screen [ Time Frame: baseline ]
    2 question screen



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300297


Contacts
Contact: Breanna C Reynolds, DPT 309-677-3293 bcreynolds@fsmail.bradley.edu

Locations
United States, Illinois
Rock Valley Physical Therapy Recruiting
Peoria, Illinois, United States, 61614
Contact: Bre C Reynolds, DPT    309-677-3293    bcreynolds@fsmail.bradley.edu   
Rock Valley Physical Therapy Recruiting
Washington, Illinois, United States, 61571
Contact: Bre C Reynolds, DPT    309-677-3293    bcreynolds@fsmail.bradley.edu   
Sponsors and Collaborators
Bradley University
Nova Southeastern University
University of Nevada, Las Vegas
Investigators
Principal Investigator: Breanna C Reynolds, DPT Bradley University

Publications:

Responsible Party: Breanna Reynolds, Assistant Professor, Bradley University
ClinicalTrials.gov Identifier: NCT03300297     History of Changes
Other Study ID Numbers: BU 59-16
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Breanna Reynolds, Bradley University:
Temporomandibular joint
Physical Therapy
Cervical spine thrust joint manipulation
therapy, exercise
Temporomandibular Disorders

Additional relevant MeSH terms:
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Pathologic Processes
Myofascial Pain Syndromes