The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals With Temporomandibular Disorders

NCT06602375 | Recruiting

• 2 other identifiers: C.2024.090d974205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial among US military active-duty service-members with temporomandibular disorders (TMD) is to determine whether standard care plus 6-weeks of tailored, individualized physical therapy (PT) treatment provides greater benefit than standard care alone in patient-reported outcomes, and maximal mouth opening. The aims of the study are to compare outcomes in individuals with TMD that receive standard care treatment versus standard care plus PT interventions at 0-, 6-, and 12-weeks. The investigators anticipate that subjects in the standard care plus PT group will exhibit improved patient-reported outcomes, and maximal mouth opening compared to those who received standard care alone. Additionally, the investigators will compare the amount and type of healthcare utilization between the two groups (Standard Care and Standard Care + PT) in the 12-month period following enrollment in the study. All participants will be managed by their primary dental provider and receive care as deemed appropriate by their provider. All participants will complete patient-reported outcome measures and have their jaw motion measured. Those randomized to the standard care plus PT group will also receive a tailored PT evaluation followed by an individualized plan of care two times per week for up to six weeks.

Conditions

Temporomandibular Disorders (TMD)

Keywords

Temporomandibular Disorders; Physical Therapy; Manual Therapy; Exercise

Outcome Measures

Primary Outcomes (1)

• Jaw Functional Limitation Scale - 8 item (JFLS-8)

  This study's primary outcome variable is the Jaw Functional Limitation Scale - 8 Item version. This 8-item questionnaire is scored from 0 to 80 points, with higher scores indicating greater levels of functional limitation. The JFLS-8 is a reliable and valid tool to measure patient functional limitations related to the jaw. This questionnaire is supported by the dental and physical therapy communities to measure functional limitations of the jaw. Each item is scored from 0-10. The scores are summed and divided by the number of items answered. No more than two items can be missing for scoring to take place.

  From enrollment to 12 weeks post enrollment (primary), will also be assed at 6-weeks

Secondary Outcomes (8)

• Numeric Pain Rating Scale (NPRS)

  At enrollment, 6-weeks, and 12-weeks

• Neck Disability Index (NDI)

  Collected at baseline, 6- and 12-weeks.

• Central Sensitization Inventory (CSI)

  Collected at baseline, 6- and 12-weeks.

• Global Rating of Change (GRoC)

  Collected at 6- and 12-weeks

• Pain-Free Mouth Opening (PFMO)

  Collected at baseline, 6- and 12-weeks.

Study Arms (2)

Standard care plus physical therapy

EXPERIMENTAL

Participants randomized to this group will receive standard care from their treating dental provider. In addition, they will receive routine physical therapy interventions over a 6-week (+/- 2 week) period. Study participants will receive treatments based on their clinical examination. Subjects will attend up to 12 sessions over 6-weeks (+/- 2 weeks). The initial physical therapy visit will be 60-minutes long with all subsequent appointments being 30-minutes, to include any booster sessions. The interventions will be pragmatic in nature, with provided treatment being specific to the subject's specific complaints, goals, and examination identified impairments.

Other: Standard care; Other: Physical Therapy (PT)

Standard Care

ACTIVE COMPARATOR

Those randomized to the standard care (control) group will follow the plan of care determined by their treating dental provider. This group will receive standard (routine) care from the dental provider for the treatment of TMD. These decisions will be based on the clinical judgment of the dental provider, as is customary with routine care for TMD.

Other: Standard care

Interventions

Standard care OTHER

The standard care (control) group will follow the plan of care determined by their treating dental provider. These decisions will be based on the clinical judgment of the dental provider and subject desires. Intervention may include, but is not limited to typical patient education, pharmacotherapy, oral splinting or occlusal device, cryo/thermotherapy recommendations, and exercise handouts.

Standard Care; Standard care plus physical therapy

Physical Therapy (PT) OTHER

Participants randomized to this group will receive individualized, tailored courses of physical therapy care. Interventions may be directed at the temporomandibular, cervical, and/or scapulothoracic regions based on subject clinical presentation and impairments. Manual therapy joint and soft tissue mobilizations may be used to address pain, mobility, and motor control. Motor control exercises may be used to promote relaxation, improve range of motion, and appropriate postures. Strengthening exercise, primarily directed to the cervical and scapulothoracic regions, may be implemented as appropriate. Stretching exercise may be used to address pain and mobility deficits. The interventions are intentionally pragmatic; study participants will receive treatment as they are comfortable and as recommended by the treating therapist.

Standard care plus physical therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Active-Duty Service Members
• Complaint of TMD symptoms
• Must be able to be followed for twelve weeks after consent
• TMD Screener score ≥ 3 45

You may not qualify if:

• Actively in a Trainee status
• Utilized oral device in past 6 months
• Facial injection therapy in the prior 6 months
• Facial surgery in the preceding 6 months
• Serious spinal pathology (acute fracture, active cancer, instability)
• Diagnosed neurological or rheumatological disease
• Currently under litigation related to temporomandibular or cervical spine pain(s)
• Currently undergoing Medical Evaluation Board (MEB)
• Retiring or separating from the military within a year

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

Related Publications (11)

• Valesan LF, Da-Cas CD, Reus JC, Denardin ACS, Garanhani RR, Bonotto D, Januzzi E, de Souza BDM. Prevalence of temporomandibular joint disorders: a systematic review and meta-analysis. Clin Oral Investig. 2021 Feb;25(2):441-453. doi: 10.1007/s00784-020-03710-w. Epub 2021 Jan 6.

  PMID: 33409693 BACKGROUND

• Fernandez-de-Las-Penas C, Von Piekartz H. Clinical Reasoning for the Examination and Physical Therapy Treatment of Temporomandibular Disorders (TMD): A Narrative Literature Review. J Clin Med. 2020 Nov 17;9(11):3686. doi: 10.3390/jcm9113686.

  PMID: 33212937 BACKGROUND

• von Piekartz H, Schwiddessen J, Reineke L, Armijo-Olivio S, Bevilaqua-Grossi D, Biasotto Gonzalez DA, Carvalho G, Chaput E, Cox E, Fernandez-de-Las-Penas C, Gadotti IC, Gil Martinez A, Gross A, Hall T, Hoffmann M, Julsvoll EH, Karegeannes M, La Touche R, Mannheimer J, Pitance L, Rocabado M, Strickland M, Stelzenmuller W, Speksnijder C, van der Meer HA, Luedke K, Ballenberger N. International consensus on the most useful assessments used by physical therapists to evaluate patients with temporomandibular disorders: A Delphi study. J Oral Rehabil. 2020 Jun;47(6):685-702. doi: 10.1111/joor.12959. Epub 2020 May 4.

  PMID: 32150764 BACKGROUND

• Bhargava D, Chavez Farias C, Ardizone Garcia I, Mercuri LG, Bergman S, Anthony Pogrel M, Sidebottom AJ, Srouji S, Senturk MF, Elavenil P, Moturi K, Anantanarayanan P, Bhargava PG, Singh VD. Recommendations on the Use of Oral Orthotic Occlusal Appliance Therapy for Temporomandibular Joint Disorders: Current Evidence and Clinical Practice. J Maxillofac Oral Surg. 2023 Sep;22(3):579-589. doi: 10.1007/s12663-023-01939-y. Epub 2023 Jun 27.

  PMID: 37534353 BACKGROUND

• Orzeszek S, Waliszewska-Prosol M, Ettlin D, Seweryn P, Straburzynski M, Martelletti P, Jenca A Jr, Wieckiewicz M. Efficiency of occlusal splint therapy on orofacial muscle pain reduction: a systematic review. BMC Oral Health. 2023 Mar 28;23(1):180. doi: 10.1186/s12903-023-02897-0.

  PMID: 36978070 BACKGROUND

• Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB. PROMIS(R) Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains. Value Health. 2019 May;22(5):537-544. doi: 10.1016/j.jval.2019.02.004.

  PMID: 31104731 BACKGROUND

• DeSouza CM, Legedza AT, Sankoh AJ. An overview of practical approaches for handling missing data in clinical trials. J Biopharm Stat. 2009 Nov;19(6):1055-73. doi: 10.1080/10543400903242795.

  PMID: 20183464 BACKGROUND

• Hoffmann RG, Kotchen JM, Kotchen TA, Cowley T, Dasgupta M, Cowley AW Jr. Temporomandibular disorders and associated clinical comorbidities. Clin J Pain. 2011 Mar-Apr;27(3):268-74. doi: 10.1097/AJP.0b013e31820215f5.

  PMID: 21178593 BACKGROUND

• Idanez-Robles AM, Obrero-Gaitan E, Lomas-Vega R, Osuna-Perez MC, Cortes-Perez I, Zagalaz-Anula N. Exercise therapy improves pain and mouth opening in temporomandibular disorders: A systematic review with meta-analysis. Clin Rehabil. 2023 Apr;37(4):443-461. doi: 10.1177/02692155221133523. Epub 2022 Oct 20.

  PMID: 36263523 BACKGROUND

• Asquini G, Pitance L, Michelotti A, Falla D. Effectiveness of manual therapy applied to craniomandibular structures in temporomandibular disorders: A systematic review. J Oral Rehabil. 2022 Apr;49(4):442-455. doi: 10.1111/joor.13299. Epub 2022 Jan 17.

  PMID: 34931336 BACKGROUND

• Minervini G, Franco R, Marrapodi MM, Fiorillo L, Cervino G, Cicciu M. Post-traumatic stress, prevalence of temporomandibular disorders in war veterans: Systematic review with meta-analysis. J Oral Rehabil. 2023 Oct;50(10):1101-1109. doi: 10.1111/joor.13535. Epub 2023 Jun 23.

  PMID: 37300526 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Motor Activity

Interventions

Standard of Care; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Rehabilitation

Study Officials

• Benjamin R Hando, PhD, DPT

  Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy, Brooke Army Medical Center

  STUDY CHAIR

Central Study Contacts

Mason A Frank, DPT

CONTACT

301-606-8511; mason.a.frank.mil@health.mil

Benjamin R Hando, PhD, DPT

CONTACT

210-602-9024; benjamin.r.hando.civ@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: This study will be a pragmatic, parallel randomized controlled trial. Participants will be randomly assigned to either the experimental (standard care plus physical therapy) or control (standard care) group.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 5, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)