NCT07785271

Brief 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. 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:
  2. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 18, 2026

Last Update Submit

August 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Manual Therapy Group

EXPERIMENTAL
Procedure: Manual Therapy Protocol

Rocabado Home Exercise Group

ACTIVE COMPARATOR
Other: Rocabado 6x6 Home Exercise Program

Interventions

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).

Manual Therapy Group

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.

Rocabado Home Exercise Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The outcome assessor conducting baseline and post-treatment clinical and ultrasonographic evaluations is blinded to participant group allocations. Due to the nature of manual therapy and exercise interventions, participants and treating physiotherapists cannot be blinded. Data analysts and investigators involved in outcome calculations are also blinded to group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 25, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08