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CTRI Number  CTRI/2025/07/090513 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Management of Head and Neck pain using different treatment modalities.  
Scientific Title of Study   Evaluation of efficacy of Transcutaneous Electric Nerve Stimulation, Therapeutic Ultrasound, Phonophoresis and Low level Laser Therapy in Management of Temporomandibular Disorders- A Comparative Study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshita Arabbi 
Designation  Post Graduate  
Affiliation  PMNM Dental College and Hospital 
Address  Department of Oral Medicine and Radiology PMNM Dental College and Hospital Navanagar Bagalkot

Bagalkot
KARNATAKA
587103
India 
Phone  6364691612  
Fax    
Email  hkarabbi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praveenkumar Ramdurg 
Designation  Professor and Head 
Affiliation  PMNM Dental College and Hospital 
Address  Department of Oral Medicine and Radiology PMNM Dental College and Hospital Navanagar Bagalkot

Bagalkot
KARNATAKA
587103
India 
Phone  8861593975  
Fax    
Email  praveenod@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Praveenkumar Ramdurg 
Designation  Professor and Head 
Affiliation  PMNM Dental College and Hospital 
Address  Department of Oral Medicine and Radiology PMNM Dental College and Hospital Navanagar Bagalkot

Bagalkot
KARNATAKA
587103
India 
Phone  8861593975  
Fax    
Email  praveenod@gmail.com  
 
Source of Monetary or Material Support  
PMNM DENTAL COLLEGE AND HOSPITAL , BAGALKOT , KARNATAKA 587103 
 
Primary Sponsor  
Name  The Principal 
Address  PMNM Dental College and Hospital Navanagar Bagalkot  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshita K Arabbi  PMNM Dental College and Hospital , Navanagar, Bagalkot 587103  Room No 1 Department of Oral Medicine and Radiology
Bagalkot
KARNATAKA 
6364691612

hkarabbi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M266||Temporomandibular joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low level laser therapy   Wavelength of 940nm mean output power of 2.5 W energy density of 900 J per TMJ for 6 mins  
Intervention  Phonophoresis   with 1 percent Diclofenac Gel along with ultrasound gel of 1 MHz at an intensity of 1.3 Wcm2 for 10 mins  
Intervention  Plain Therapeutic Ultrasound   frequency of 1Mz at an intensity of 1.3 Wcm2 for 10 mins  
Comparator Agent  Transcutaneous Electric nerve stimulation   Electrodes with adjustable intensity from 10 to 15 frequency of 75hz and pulse width of 120 for 15 mins per session  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Males and females of Age between 20 to 50 years will be enrolled as study group.
2. Patients with history of chronic TMJ pain for more than 1 month
3. Patients under GROUP 1 Myofascial Pain and GROUP 2 Disc Displacement of RDC TMD Criteria
4. Patients who are self-willing to participate are included in the study.
 
 
ExclusionCriteria 
Details  1. Patients with the history of Pacemakers, recent trauma, open facial wounds, Implants in craniofacial region.
2.Patients who are under regular medications such as muscle relaxants, anti- depressants, anti- convulsant, anxiolytics.
3.Patients with history of any systemic disorders.
4. Patients with history of known allergies.
5. Patients with pain of odontogenic origin or arthrogenic pain as per (RDC/TMD Group III) 6. Patients who are previously treated with TENS, Th US, Phonophoresis, and LLT without improved conditions.
7.Females who are pregnant or lactating will be ruled out.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The results concluded that Low Level Laser Therapy showed significant improvement in all parameters like Pain score VAS, Helkimo Dysfunctional Index , and Maximum Mouth Opening followed by subjects of Th US, and the least improvement was noted in subjects with TENS therapy   All the above mentioned 4 modalities will be carried out for 2 times / week for 2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/07/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [hkarabbi@gmail.com].

  6. For how long will this data be available start date provided 22-06-2025 and end date provided 20-06-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The Temporomandibular Joint (TMJ) is a vital anatomical structure that connects the mandible (lower jaw) to the temporal bone of the skull. TMJ has a crucial role in monitoring the mandibular movements thereby controlling various essential daily tasks such as chewing, speaking, swallowing, and facial movements.

Temporomandibular Disorders (TMD) are a common musculoskeletal condition that cause significant discomfort and functional limitations. These disorders often manifest as chronic pain, joint dysfunction, & muscular stiffness, leading to difficulties in chewing, speaking, and performing daily activities.

As conventional pharmacological and surgical treatments have limitations or adverse effects, there is an increasing need for effective, non-invasive therapeutic approaches for the treatment of temporomandibular disorders.

Among the various physiotherapeutic modalities, Transcutaneous Electric Nerve Stimulation (TENS), Therapeutic Ultrasound (TUS), Phonophoresis, and Low-Level Laser Therapy (LLLT) have been widely utilized for pain relief and functional improvement in TMD patients.

These techniques offer different mechanisms of actions, including neuromodulation (TENS), deep tissue heating (TUS), enhanced drug absorption (Phonophoresis), and photo biomodulation (LLLT), all of which contribute to pain reduction and muscle relaxation.

However, despite their widespread use, there is a lack of consensus regarding their comparative effectiveness in managing TMD To assess the impact of these interventions, Visual Analog Scale (VAS) score will be utilized as outcome measures. The VAS score, on the other hand, is a validated tool for measuring subjective pain perception, providing insight into the patient’s pain experience and functional improvement. By integrating clinical (VAS) parameters, this study will provide a comprehensive evaluation of the therapeutic effectiveness of these modalities. The findings will help determine the most suitable non-invasive treatment for TMDs, contributing to evidence-based clinical decision-making and improved patient care.

 
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