NCT07703059

Brief Summary

Temporomandibular joint dysfunction (TMD) is a common musculoskeletal disorder affecting the jaw joint and masticatory muscles, leading to pain, limited jaw function, and reduced quality of life. Conservative management includes therapeutic exercises and manual therapy. Rocabado exercises improve jaw mechanics and posture, while the Strain Counterstrain technique reduces muscle tenderness and pain. This randomized controlled trial aims to evaluate the effectiveness of Rocabado exercises alone versus Rocabado exercises combined with the Strain Counterstrain technique in patients with muscular TMD. The intervention will be conducted over six weeks, with outcomes measured for pain, jaw function, and quality of life. The study seeks to determine whether the combined approach provides superior clinical outcomes.

Trial Health

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Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Jul 2026Nov 2026

Study Start

First participant enrolled

July 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale for pain (NPRS)

    Measures the intensity of pain. The NPRS is an 11-point scale, ranging from 0 (no pain) to 10 (worst imaginable pain). Patients are asked to rate their current pain, average pain, or worst pain over a specific period (e.g., past 24 hours or week). Interpretation as No pain, 1-3 = Mild pain, 46 weeks-6 = Moderate pain 7-10 = Severe pain

    6 weeks

  • Jaw Functional Limitation Scale for jaw function (JFLS-8)

    Assesses limitations in jaw function in patients with temporomandibular disorders. The JFLS-8 is a short version with 8 items, each rated on a 5-point Likert scale from 0 (no limitation) to 4 (severe limitation). Domains assessed mastication (chewing), jaw mobility (opening/closing), verbal communication (speaking) Scoring as higher scores indicate greater functional limitation. Total score is usually calculated as the sum or average of the 8 items. 0= No jaw functional limitation, 1-3 =Mild functional limitation, 4-6 = Moderate functional limitation, 7-10 = Severe functional limitation. Higher scores indicate greater jaw functional impairment.(20)

    6 weeks

Secondary Outcomes (1)

  • Oral Health Impact Profile for quality of life (OHIP-14)

    6 weeks

Study Arms (2)

Rocabado Exercises + Strain Counterstrain Technique

EXPERIMENTAL

Participants will receive Rocabado exercises combined with the Strain Counterstrain technique. A hot pack will be applied for 15 minutes, followed by Rocabado 6×6 exercises and application of Strain Counterstrain to masticatory muscles (masseter, temporalis, pterygoids). Sessions will be 45 minutes, 2-3 times per week for 6 weeks.

Other: Rocabado ExerciseOther: Strain Counterstrain Technique

Rocabado Only

ACTIVE COMPARATOR

Participants will receive Rocabado exercises only. A hot pack will be applied for 15 minutes, followed by Rocabado 6×6 exercises. Sessions will be 45 minutes, 2-3 times per week for 6 weeks.

Other: Rocabado Exercise

Interventions

Rocabado exercises constitute a standardized 6×6 therapeutic protocol aimed at restoring normal temporomandibular joint (TMJ) biomechanics and craniocervical alignment. The intervention incorporates neuromuscular re-education techniques including tongue resting position, controlled mandibular rotation, rhythmic stabilization, axial extension of the cervical spine, and scapular postural correction. These exercises are designed to optimize joint kinematics, enhance proprioceptive control, reduce abnormal muscle activity, and improve functional jaw mobility while minimizing pain.

Rocabado Exercises + Strain Counterstrain TechniqueRocabado Only

The Strain Counterstrain (SCS) technique is a passive, indirect manual therapy approach targeting myofascial tender points. It involves precise positioning of the involved muscle in a shortened, position of maximal comfort to reduce aberrant muscle spindle activity and nociceptive input. Sustained positioning (typically 60-90 seconds) facilitates neuromuscular reset, decreases localized hypertonicity, and alleviates pain. In this study, SCS will be applied to the masticatory muscles, including the masseter, temporalis, and pterygoid muscles, to improve muscle function and reduce pain sensitivity.

Rocabado Exercises + Strain Counterstrain Technique

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed patient of muscular TMJ ;According to Fonseca Questionnaire, ranging in the age group of 20 to 50 years, with both male and female were included in the study; Maximum mouth opening (MMO) 40-60mm for diagnosis of muscular TMJ ; Mild to moderate TMJ pain ; Unilateral TMJ ; Diagnostic features of muscular TMJ dysfunction: Pain location: Jaw, temple and masseter region ; Pain Behavior: Increase with chewing, talking and clenching ; Palpation findings: tenderness at masseter and temporal region ; ROM findings: limited and painful mouth opening (\<40mm) when measured with maximum mouth opening test ; MMO Test: The test involves measuring the maximum distance between the incisal edges of the upper and lower central incisors when the mouth is opened as wide as possible. This measurement is typically performed using a calibrated ruler, Vernier calipers, or a fiber ruler, with the subject positioned upright and instructed to open their mouth maximally.

You may not qualify if:

  • Who do not fall into the mentioned age group, with severe TMJ dysfunction according to Fonseca Questionnaire ; Recent oral surgeries; Spondyloarthropathies ;Recent oral trauma ; Systemic disease(hypothyroidism, hypercalcemia) ; Pregnant females ;Metal implants in the oral cavity ; Patient on TMJ drugs use ; Lactating females ; Neurological deficit (MS, Parkinson diseases) that effects the fascial muscles ; Any other inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki Trust and Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 14, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 20, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations