Manual Therapy vs. Home Exercise in Myogenic TMD With Neck Pain

NCT07785271 — Not applicable, Not yet recruiting, 34 participants, Pamukkale University

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Comparative Effects of Manual Therapy Versus Home Exercise on Pain, Function, and Masseter Muscle Properties in Myogenic Temporomandibular Disorder With Neck Pain: A Randomized Controlled Trial.

Registry	NCT07785271
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	34 (Estimated)
Sponsor	Pamukkale University (Other)
Conditions	Temporomandibular Joint Disorders, Neck Pain Musculoskeletal
Interventions	Manual Therapy Protocol, Rocabado 6x6 Home Exercise Program (Procedure, other)
Dates	start 2026-09-01 (estimated), primary completion 2027-01-30 (estimated), completion 2027-02-28 (estimated), first posted 2026-08-25, last updated 2026-08-25

-Summary

Temporomandibular disorders (TMD) are common musculoskeletal conditions affecting the jaw joint and surrounding chewing muscles. Myogenic TMD specifically involves muscle pain and dysfunction, which is frequently accompanied by chronic neck pain due to the close anatomical and neurophysiological connections between the jaw and the cervical spine.

The purpose of this study is to compare the clinical effectiveness of two widely used physiotherapy interventions-a clinician-administered manual therapy protocol and a patient-conducted home exercise program-in individuals diagnosed with myogenic TMD and chronic neck pain. The main research question is to determine whether targeted manual therapy applied to both the temporomandibular and cervical regions yields superior improvements in pain, jaw and neck mobility, quality of life, and masseter muscle properties compared to the Rocabado 6x6 home exercise program alone.

1. A total of 34 participants aged 18-45 years with myogenic TMD and chronic neck pain will be randomly allocated into two equal groups:

Manual Therapy Group: Participants receive 6 individual treatment sessions (3 days per week for 2 weeks) consisting of soft tissue mobilization, trigger point therapy, myofascial release, and joint mobilization techniques applied to the jaw and neck regions.
2. Exercise Group: Participants perform the standardized Rocabado 6x6 home exercise program 3 days per week for 2 weeks, with adherence monitored through daily exercise diaries.

All participants undergo comprehensive assessments at baseline and immediately following the 2-week intervention. Evaluated parameters include jaw and neck pain intensity (Visual Analog Scale), cervical and mandibular range of motion, cervical joint position sense, jaw proprioception, facial asymmetry, bruxism, TMD severity, movement-related fear (kinesiophobia), and quality of life. In addition, masseter muscle thickness and elasticity are objectively assessed using ultrasound imaging and elastography.

The findings of this trial aim to provide healthcare professionals with high-level evidence regarding effective, targeted physiotherapy strategies for managing myogenic TMD co-occurring with cervical pain.

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+Arms and interventions

Arm	Type	Interventions	Description
Manual Therapy Group	Experimental	Procedure: Manual Therapy Protocol
Rocabado Home Exercise Group	Active comparator	Other: Rocabado 6x6 Home Exercise Program

Manual Therapy Protocol (Procedure): Clinician-administered targeted manual therapy protocol applied to both the temporomandibular joint and cervical spine regions. The treatment includes soft tissue mobilization, myofascial release, trigger point therapy, and joint mobilization techniques. Administered in 6 individual treatment sessions over 2 weeks (3 sessions per week).
Rocabado 6x6 Home Exercise Program (Other): Standardized patient-conducted Rocabado 6x6 home exercise program focusing on mandibular and cervical posture, mobility, and muscular control. Performed 3 days per week for 2 weeks. Patient adherence and compliance are tracked using daily exercise logbooks.

+Outcome measures

Primary outcomes

Temporomandibular Joint Pain Intensity at Rest, During Activity, and During Chewing Assessed by Visual Analog Scale (VAS). [Baseline and Week 2, immediately post-treatment]
Title: Neck Pain Intensity Assessed by Visual Analog Scale (VAS). [Baseline and 2 weeks post-treatment]

Secondary outcomes

Cervical Spine Active Range of Motion Assessed by Baseline CROM Deluxe Device. [Baseline and 2 weeks post-treatmen]
Cervical Joint Position Error Assessed by Baseline CROM Deluxe Device [Baseline and 2 weeks post-treatmen]
Mandibular Range of Motion Assessed by Digital Caliper [Baseline and 2 weeks post-treatment]
Jaw Proprioception Assessed by Active Movement Extent Discrimination Apparatus (AMEDA) Protocol. [Baseline and 2 weeks post-treatment]
Facial Asymmetry Assessed by Tape Measure [Baseline and 2 weeks post-treatment]
Kinesiophobia Assessed by Tampa Scale for Kinesiophobia for Temporomandibular Disorders - Short Form (TSK-TMD-12). [Baseline and 2 weeks post-treatment]
Health-Related Quality of Life Assessed by 12-Item Short Form Survey (SF-12). [Baseline and 2 weeks post-treatment]
Self-Reported Awake and Sleep Bruxism Assessed by Patient Questionnaire. [Baseline and 2 weeks post-treatment]
Temporomandibular Disorder Severity Assessed by the Fonseca Anamnestic Index (FAI) / Fonseca Questionnaire. [Baseline and 2 weeks post-treatment]
Bilateral Masseter Muscle Thickness Assessed by Ultrasonography. [Baseline and 2 weeks post-treatment]

+Eligibility

Sex: All, ages: 18 Years to 45 Years

Inclusion Criteria:

* Presence of TMJ pain at rest,
* TMJ pain persisting for at least 3 months,
* Neck pain persisting for at least 3 months,
* Willingness to participate in the study.

Exclusion Criteria:

* Any orthopedic and/or neurological condition that would preclude the assessments,
* Cardiac history or surgery severe enough to preclude exercise,
* Diagnosis of any psychiatric disorder,
* Any condition precluding assessment or communication,
* History of orthopedic surgery in any region,
* Receipt of physiotherapy or any other treatment for the TMJ or spinal region within the previous 6 months,
* Illiteracy,
* A positive vertebrobasilar artery test.