- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703059
Effect of Rocabado Exercises With Strain Counter-Strain Technique on Muscles of Mastication for Pain, Jaw Function, and Quality of Life in Patients With Temporomandibular Joint Dysfunction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Temporomandibular joint dysfunction (TMD) is a common musculoskeletal condition affecting the jaw joint and muscles of mastication, leading to pain, restricted jaw movement, and reduced quality of life. It is often associated with factors such as muscle spasm, poor posture, stress, and abnormal jaw mechanics. Various conservative treatment approaches are used, including physical therapy, exercises, and manual therapy techniques. Among these, Rocabado exercises aim to restore normal jaw function, improve posture, and enhance neuromuscular control, while the Strain Counterstrain technique focuses on reducing muscle tenderness and pain by positioning the affected muscle in a relaxed state.
This study aims to evaluate the combined effect of Rocabado exercises and the Strain Counterstrain technique on pain, jaw function, and quality of life in patients with muscular TMD. A randomized controlled trial will be conducted on participants divided into two groups: one receiving Rocabado exercises alone and the other receiving a combination of Rocabado exercises and Strain Counterstrain technique. The intervention will be carried out over six weeks, with outcomes measured using standardized tools for pain, functional limitation, and quality of life. The findings of this study may help in identifying a more effective physiotherapy approach for managing TMD and improving patient outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nimra khalil
- Phone Number: 03090505681
- Email: nimrakhalil887@gmail.com
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Ghurki Trust and Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Rocabado Exercises + Strain Counterstrain Technique
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.
|
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.
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.
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Active Comparator: Rocabado Only
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale for pain (NPRS)
Time Frame: 6 weeks
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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
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6 weeks
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Jaw Functional Limitation Scale for jaw function (JFLS-8)
Time Frame: 6 weeks
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral Health Impact Profile for quality of life (OHIP-14)
Time Frame: 6 weeks
|
Evaluates the impact of oral conditions on quality of life.
OHIP-14 is a shortened version of the original OHIP (49 items), containing 14 questions across 7 domains such as Functional limitation, Physical pain, psychological discomfort, Physical disability, psychological disability, social disability, Handicap Scoring: Each item is rated on a 5-point Likert scale: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often.
Higher scores = poorer oral health-related quality of life.
To calculate the total score, sum the scores of all 14 items.
The total score ranges from 0 to 56, where a higher score indicates a greater negative impact on oral health-related quality of life.
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6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UBAS/ERB/26/04/028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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