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CTRI Number  CTRI/2025/06/089291 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficient use of ultrasound therapy with or without diclofenac gel in relieving pain in facial and neck muscles. 
Scientific Title of Study   The efficacy of phonophoresis over conventional ultrasound therapy for pain relief in patients with Myofascial Pain Syndrome-a randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Richa Srivastava 
Designation  post graduate student 
Affiliation  DY Patil school of dentistry, Nerul, Navi Mumbai 
Address  L11 Rh2 Sector 6 Vashi Navi Mumbai-400703

Thane
MAHARASHTRA
400703
India 
Phone  09819271306  
Fax    
Email  richalucknow49@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandavi Waghmare 
Designation  Professor 
Affiliation  DY Patil school of dentistry, Nerul, Navi Mumbai 
Address  Sector 7, Nerul, Navi Mumbai-400706
Sector 7,Nerul, Navi Mumbai, 400706
Thane
MAHARASHTRA
400703
India 
Phone  08108069665  
Fax    
Email  mandavi.waghmare@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Richa Srivastava 
Designation  post graduate student 
Affiliation  DY Patil school of dentistry, Nerul, Navi Mumbai 
Address  L11 Rh2 Sector 6 Vashi Navi Mumbai-400703

Thane
MAHARASHTRA
400703
India 
Phone  09819271306  
Fax    
Email  richalucknow49@gmail.com  
 
Source of Monetary or Material Support  
DY PATIL SCHOOL OF DENTISTRY 
 
Primary Sponsor  
Name  DY Patil School of Dentisty 
Address  Sector 7, Nerul, Navi Mumbai-400706, Maharashtra, India 
Type of Sponsor  Other [Private dental College] 
 
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 MANDAVI WAGHMARE  Tobacco Cessation Clinic,Department of oral medicine and radiology, DYPSOD  DY Patil School of Dentistry,Sector 7 , Nerul, Navi Mumbai-400703
Thane
MAHARASHTRA 		 08108069665

mandavi.waghmare@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL RESEARCH AND ETHICAL BOARD D. Y. PATIL DEEMED TO BE UNIVERSITY SCHOOL OF DENTISTRY, NAVI MUMBAI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diclofenac diethylamine 1.16% gel that is applied topically over the affected site .   This gel is equivalent to diclofenac sodium IP 1%w/w available with the brand name of Voveran gel that has pain relieving properties. 
Comparator Agent  The comparator is ultrasound therapy for relief of muscle spasm and tenderness in myofascial pain syndrome patients.  The intervention with therapeutic ultrasound is compared with therapeutic ultrasound alone without topical analgesic to compare the healing and synergistic properties of topical analgesic and Ultrasound therapy versus ultrasound therapy alone. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in age group of 18-60 years
Patients who satisfy Laskins criteria for MPDS
Patients not taking any medications /alternate therapy for MPDS
 
 
ExclusionCriteria 
Details  Pregnant and lactating women, those with pacemakers, diclofenac allergy, the pain of odontogenic origin, neuralgias, neuromuscular disorders, already treated with anti-inflammatory, muscle relaxant, and analgesic drugs, intraarticular temporomandibular joint disorders, jaw tumors, and trauma. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in mouth opening
Reduction in tenderness on opening the mouth

Reduction in individual muscle tenderness
Reduction in individual muscle tenderness 		 After 8 sessions spread over 8 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil   
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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 4 
Date of First Enrollment (India)   01/07/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - 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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [richalucknow49@gmail.com].

  6. For how long will this data be available start date provided 10-03-2026 and end date provided 11-03-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

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

AIM: To assess the comparative efficacy of phonophoresis over conventional ultrasound therapy in patients with myofascial pain syndrome.

OBJECTIVE:

Reduction in muscle tenderness

Reduction of pain on opening the mouth

Improvement in mouth opening

HYPOTHESIS: There is no difference in the efficacy of phonophoresis over conventional Ultrasound therapy in patients with myofascial syndrome.

METHODOLOGY:

STUDY DESIGN: Randomized control trial

STUDY DURATION: The study is expected to get completed in 1 months

STUDY POPULATION: Indian nationals in the age group of 18-60 years

INCLUSION CRITERIA: Patients in age group of 18-60 years

Patients who satisfy Laskins criteria for MPDS

Patients not taking any medications /alternate therapy for MPDS

EXCLUSION CRITERIA: Pregnant and lactating women, those with pacemakers, diclofenac allergy, the pain of odontogenic origin, neuralgias, neuromuscular disorders, already treated with anti-inflammatory, muscle relaxant, and analgesic drugs, intraarticular temporomandibular joint disorders, jaw tumors, and trauma.

SAMPLE SIZE: 26

SUBJECT SELECTION: Subjects visiting the OPD of the Department of Oral Medicine and Radiology and satisfying the Laskins criteria for MPDS will be enrolled in the study.

  The patient will be informed about the research project and a written consent will be taken if the patient agrees to be a part of the study. 

Randomization method: Patients will be allotted to one of the treatment arms through a simple random sampling method

 TREATMENT DETAILS: The patients will be randomly divided into two groups of 13 patients each.

Group A will be treated with Ultrasound therapy with anti-inflammatory gel for 8 sittings of 8 minutes each over trigger points , with intensity of 1-1.5 watts per cm2 in continuous mode, Group B will be treated with with Ultrasound therapy without anti-inflammatory gel for 8 sittings of 8 minutes each over trigger points , with intensity of 1-1.5 watts per cm2 in continuous mode.

EXPECTED OUTCOME: Patients being treated with Ultrasound therapy along with anti-inflammatory gel are expected to have quicker/better relief.

 
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