| CTRI Number |
CTRI/2025/12/099699 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing how well regular ultrasound therapy works versus ultrasound combined with a special pain-relief gel for treating muscle pain problem. |
|
Scientific Title of Study
|
Comparative efficacy of Therapeutic Ultrasound versus Phonophoresis with Permeation-Enhanced Diclofenac-Tizanidine Gel in Myofascial Pain Dysfunction Syndrome:A Randomized Controlled Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Ramswarup Somani |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept.of Oral Medicine and Radiology Sharad Pawar Dental College building ground floor, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
09561479017 |
| Fax |
|
| Email |
sakshisomani09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSuwarna Dangore |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept.of Oral Medicine and Radiology Sharad Pawar Dental College building ground floor, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923024036 |
| Fax |
|
| Email |
dangore_suwarna@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSuwarna Dangore |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept.of Oral Medicine and Radiology Sharad Pawar Dental College building ground floor, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923024036 |
| Fax |
|
| Email |
dangore_suwarna@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Sakshi Somani |
Sharad Pawar Dental College |
Dept. of Oral Medicine and Radiology, Ground Floor, SPDC Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9561479017
sakshisomani09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Phonophoresis with Permeation Enhanced Diclofenac Tizanidine gel |
Therapeutic ultrasound used to facilitate delivery of diclofenac tizanidine gel to affected myofascial region in patients with myofascial pain dysfunction syndrome |
| Comparator Agent |
Therapeutic Ultrasound alone |
Conventional therapeutic ultrasound applied to the affected myofascial region without any topical drug application. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Pain in preauricular region
2. Pain on palpation of masticatory muscles
3. Presence of joint sounds clicking
4. Restricted mouth opening
5. No clinical, radiographic or biochemical evidence of organic joint disease
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women
2.Patient with pacemakers
3.Known Allergy to Diclofenac Tizanidine
4.Pain of Odontogenic origin
5.Neuralgia or neuromuscular disorder
6.Currently on anti-inflammatory, muscle relaxants analgesic medication
7.Intra-articular TMJ disorders
8.Jaw tumors
9.History of trauma |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Intensity measured using Visual analog scale |
2 weeks interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maximum mouth opening measured using Jaw Functional Limitation Scale |
2 weeks interval |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| 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="2"
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
|
Background: Myofascial Pain Dysfunction Syndrome (MPDS) is a common musculoskeletal condition characterized by muscle pain, trigger points, and functional limitation. Physical therapy modalities such as therapeutic ultrasound and phonophoresis are widely used to relieve pain and inflammation. However, evidence comparing their relative efficacy, especially with permeation-enhanced diclofenac–tizanidine gel, remains limited, warranting comparative clinical evaluation. Aims: To compare the efficacy of therapeutic ultrasound versus phonophoresis with permeation-enhanced diclofenac–tizanidine gel in reducing pain and improving function in patients with Myofascial Pain Dysfunction Syndrome. Methodology: A randomized parallel-group active-controlled clinical trial was conducted on patients diagnosed with Myofascial Pain Dysfunction Syndrome. Participants were randomly allocated to receive either therapeutic ultrasound or phonophoresis with permeation-enhanced diclofenac–tizanidine gel. Pain intensity and functional outcomes were assessed pre- and post-intervention using standardized clinical scales. |