Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder

NCT03300297 | Completed

• 1 other identifier: BU 59-16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Temporomandibular Disorder

Keywords

Temporomandibular joint; Physical Therapy; Cervical spine thrust joint manipulation; therapy, exercise; Temporomandibular Disorders

Outcome Measures

Primary Outcomes (5)

• Change in Maximal Mouth Opening Range of Motion (mm)

  Jaw ROM, mouth opening

  baseline, immediate, 1 week, 4 week

• Change in Pain with Numeric Pain Rating Scale

  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

  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

  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

  perception of overall change in a self report scale from -7 to +7

  immediate, 1 week, 4 week

Secondary Outcomes (6)

• Change in Function with Neck Disability Index

  baseline, 1 week, 4 week, 3 month, 6 month

• Change in Function with TMD Disability Index

  baseline, 1 week, 4 week, 3 month, 6 month

• Patient Acceptable Symptom State

  4 week, 3 month, 6 month

• Change in Cervical Spine range of motion

  baseline, immediate, 1 week, 4 week

• Change in Pain pressure threshold

  baseline, immediate, 1 week, 4 week

Study Arms (2)

Cervical Spine Thrust Joint Manipulation

ACTIVE COMPARATOR

Thrust Manipulation delivered to C0/1 and C2/3 on both the right and left side

Other: Cervical Spine Thrust Joint Manipulation; Other: Home Program; Other: Suboccipital Release

Cervical Spine Sham Manipulation

SHAM COMPARATOR

Sham Manipulation delivered to C0/1 and C2/3 on both the right and left side

Other: Cervical Spine Sham Manipulation; Other: Home Program; Other: Suboccipital Release

Interventions

Cervical Spine Thrust Joint Manipulation OTHER

High velocity, short amplitude thrust to the cervical spine

Also known as: Grade V manipulation

Cervical Spine Thrust Joint Manipulation

Cervical Spine Sham Manipulation OTHER

Manipulative hold position shy of end range without a thrust

Cervical Spine Sham Manipulation

Home Program OTHER

therapeutic exercise program and education

Cervical Spine Sham Manipulation; Cervical Spine Thrust Joint Manipulation

Suboccipital Release OTHER

suboccipital soft tissue mobilization

Also known as: soft tissue mobilization

Cervical Spine Sham Manipulation; Cervical Spine Thrust Joint Manipulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bradley University: lead
• Nova Southeastern University: collaborator
• University of Nevada, Las Vegas: collaborator

Study Sites (2)

Rock Valley Physical Therapy

Peoria, Illinois, 61614, United States

Location

Rock Valley Physical Therapy

Washington, Illinois, 61571, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Temporomandibular Joint Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Breanna C Reynolds, DPT

  Bradley University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to group allocation. Blind assessors will be utilized to measure objective change in range of motion and pain pressure threshold.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: October 18, 2017
• Primary Completion: October 2, 2018
• Study Completion: December 6, 2018
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)