| CTRI Number |
CTRI/2025/09/095199 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on reducing jaw pain and improving jaw function using a combination of physiotherapy and laser treatment |
|
Scientific Title of Study
|
Evaluation of the Synergistic Effects of Integrative PhysiOsteopathic Therapy Combined with Low-Level Laser Therapy (LLLT) on Pain Reduction, Functional Improvement, Psychological Well-being, and Quality of Life in Patients with Temporomandibular Disorders (TMD): A Randomized Controlled Trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara. Punjab, India. PIN-144411
Kapurthala
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara. Punjab, India. PIN-144411
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara. Punjab, India. PIN-144411
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Uni-hospital, Department of Physiotherapy, Block: 3, Room No: 105, Lovely Professional University, Phagwara, Punjab, India. PIN: 144411 |
|
|
Primary Sponsor
|
| Name |
Dr Ramesh Chandra Patra |
| Address |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara. Punjab, India. PIN-144411 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Chandra Patra |
Lovely Professional University Faculty of Applied Medical Sciences |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara. Punjab, India. PIN-144411
Jalandhar
PUNJAB |
09653174563
ramesh.19500@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University, Punjab |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M279||Disease of jaws, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrative PhysiOsteopathic Therapy |
Total duration of the treatment is 3 months. Treatment Techniques:
Craniofacial Osteopathic Techniques:
Gentle myofascial release applied to the temporalis, masseter, and pterygoid muscles.
Cranial bone mobilization techniques (e.g., temporal bone mobilization) to restore cranial bone motion and TMJ alignment.
Soft tissue manipulation focused on the suboccipital region, cervical spine, and masticatory muscles to improve circulation and reduce fascial restrictions.
TMJ Mobilization:
Passive mobilization of the TMJ joint in anterior, posterior, and lateral directions to improve joint mechanics and reduce hypomobility.
Postural Correction and Muscle Re-education:
Techniques to improve head, neck, and shoulder posture.
Neuromuscular re-education exercises aimed at stabilizing jaw function.
Treatment Schedule:
Frequency: 1 session per week.
Duration: Each session lasts approximately 30–45 minutes.
Total Duration: 4 consecutive weeks (total of 4 sessions).
2. Low-Level Laser Therapy (LLLT)
Low-Level Laser Therapy (LLLT) is a non-invasive photobiomodulation technique that uses low-power lasers to stimulate cellular function, reduce inflammation, and promote tissue healing.
Procedure:
Device Specifications:
Wavelength: 810 nm (near-infrared spectrum).
Output Power: 100 mW (continuous wave).
Energy Density (Fluence): 4 J/cm² per point.
Treatment Sites:
Bilateral TMJ region (anterior, superior, and posterior aspects).
Masseter and temporalis muscle trigger points.
Submandibular regions.
Application Method:
The laser probe is held perpendicular to the skin surface.
Treatment time: Approximately 60 seconds per point (exact exposure time calculated to deliver the specified energy density).
Number of Points per Side: 5–6 key points covering muscle and joint areas. |
| Comparator Agent |
Sham Low-Level Laser Therapy (LLLT) |
Procedure:
The same laser device will be applied to the same anatomical points as in the active LLLT group.
However, the laser will be inactive (zero power output) or use a placebo mode with no actual energy delivered.
This keeps the blinding intact and ensures patients in the control group have the same experience minus the therapeutic laser energy. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants eligible for this study must have a confirmed diagnosis of temporomandibular disorder (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), verified by a qualified clinician. Eligible individuals must report subjective pain in the temporomandibular joint and/or masticatory muscles of at least 4 on the Visual Analog Scale (VAS) on a 0 to 10 scale at baseline. Additionally, participants must exhibit functional impairment, such as reduced maximum mouth opening or difficulty chewing, demonstrating the clinical impact of the disorder. Only those with a chronic condition, defined as symptoms persisting for at least three months, will be included. Finally, participants must have the ability and willingness to provide written informed consent and comply with all study procedures. |
|
| ExclusionCriteria |
| Details |
Previous TMJ Surgery
History of surgical intervention on the temporomandibular joint.
Systemic Rheumatologic or Autoimmune Disorders
Conditions such as rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis affecting the craniofacial or musculoskeletal system.
Neurological Disorders
Neuropathies, trigeminal neuralgia, multiple sclerosis, or other central/peripheral nervous system disorders affecting craniofacial function.
Active Malignancy
Active cancer in the craniofacial region or systemic malignancies.
Pregnancy or Breastfeeding
Due to unknown effects of LLLT on pregnancy and developing fetus.
Photosensitivity Disorders
History of conditions like lupus or porphyria making the patient sensitive to light-based therapies.
Current Use of Muscle Relaxants or Analgesics (Unstable Regimen)
Patients who have changed or plan to change medication within 1 month of study entry.
Severe Psychiatric Illness
Active major depression, psychosis, or inability to cooperate with the study protocol.
Infection or Skin Lesion in Treatment Area
Active infection, open wounds, or dermatitis in the TMJ or surrounding areas.
Participation in Another Clinical Trial
Participation in another interventional study within the past 3 months. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes of this study will focus on three key domains: pain intensity, jaw functionality, and quality of life. Pain intensity will be assessed using both the Visual Analog Scale (VAS) and the Numeric Rating Scale (NRS), each ranging from 0 (no pain) to 10 (worst possible pain), providing a quantitative measure of the patient’s subjective pain experience. Jaw functionality will be evaluated through Maximum Mouth Opening (MMO) measured in millimeters, as well as the Jaw Functional Limitation Scale (JFLS), a patient-reported questionnaire assessing limitations in activities such as chewing, speaking, and yawning. Quality of life will be measured using the Oral Health Impact Profile-14 (OHIP-14), which captures the impact of temporomandibular disorder symptoms on daily activities, psychosocial well-being, and overall oral health-related quality of life. |
Baseline, 4 weeks, and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcomes will be assessed to evaluate the broader impact of the intervention. Psychological well-being will be measured using the Beck Depression Inventory (BDI) to assess depressive symptoms and the State-Trait Anxiety Inventory (STAI) to capture both temporary and long-standing anxiety levels. Patient-perceived overall improvement will be recorded using the Global Perceived Effect (GPE) scale. Optionally, electromyographic (EMG) activity of the jaw muscles may be measured to provide objective data on neuromuscular function and muscle activity patterns before and after the intervention. Collectively, these primary and secondary outcomes will allow a comprehensive evaluation of the therapeutic effects of the combined Integrative PhysiOsteopathic Therapy and Low-Level Laser Therapy on patients with temporomandibular disorders. |
Baseline, 4 weeks, and 3 months |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled trial designed to evaluate the effectiveness of combined Integrative PhysiOsteopathic Therapy and Low-Level Laser Therapy in patients with temporomandibular disorders. The study will include adults aged 18 to 65 years diagnosed with TMD who experience moderate to severe pain and functional limitation. Participants will be randomly assigned to one of three groups: the intervention group receiving physiosteopathic therapy plus low-level laser therapy, a control group receiving sham therapy, and an optional standard care group receiving conventional physiotherapy. The primary outcomes will include pain intensity measured using the visual analog scale and numeric rating scale, jaw functionality assessed with maximum mouth opening and the jaw functional limitation scale, and quality of life measured by the oral health impact profile 14. Secondary outcomes will include psychological well-being assessed with the Beck Depression Inventory and State Trait Anxiety Inventory, global perceived effect, and optional electromyographic activity of jaw muscles. The study aims to determine whether the combined therapy provides superior improvement in pain, function, and quality of life compared to sham or standard care. |