| CTRI Number |
CTRI/2025/07/090581 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| 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
|
Comparison of TENS, Ultrasound, and Phonophoresis Therapies in Reducing Jaw Muscle Pain and Dysfunction |
|
Scientific Title of Study
|
Evaluating the Effectiveness of Transcutaneous Electric Nerve Stimulation, Ultrasound and Phonophoresis in Myofascial Pain Dysfunction Syndrome- A Comparative 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 |
Dr Jhanvi Shah |
| Designation |
PG Student |
| Affiliation |
Government Dental college And hospital Jamnagar |
| Address |
Ground floor Department Of Oral Medicine And Radiology
Government Dental College And Hospital, Jamnagar, Pathikashram main road Navagam, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9426638336 |
| Fax |
|
| Email |
Jhanvishah969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reeta Jha |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental college And hospital Jamnagar |
| Address |
Ground floor Department Of Oral Medicine And Radiology
Government Dental College And Hospital, Jamnagar, Pathikashram main road Navagam, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9429272080 |
| Fax |
|
| Email |
reetajha01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jhanvi Shah |
| Designation |
PG Student |
| Affiliation |
Government Dental college And hospital Jamnagar |
| Address |
Ground floor Department Of Oral Medicine And Radiology
Government Dental College And Hospital, Jamnagar, Pathikashram main road Navagam, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9426638336 |
| Fax |
|
| Email |
Jhanvishah969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Hospital, Jamnagar, Pathikashram Main Road, Navagam, Jamnagar, Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Dr Jhanvi Shah |
| Address |
Department Of Oral Medicine And Radiology,
Government Dental College And Hospital Jamnagar, Pathikashram Main Road, Navagam, Jamnagar, Gujarat 361008 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Jhanvi Shah |
Government Dental college and Hospital jamnagar |
Ground floor
Department Of Oral Medicine And Radiology
Jamnagar
GUJARAT |
09426638336
Jhanvishah969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M.P. Shah Medical College And Guru Gobind Singh Hospital Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
phonophoresis therapy |
palpate the tender muscles and apply phonophoresis therapy for 10mins by adding muscle relaxant and ultrasound gel in 1:1 ratio |
| Intervention |
TENS Therapy |
palpate the muscles which are tender and apply TENS therapy for 20 mins |
| Comparator Agent |
Therapeutic Ultrasound therapy |
palpate the tender muscles and give ultrasound therapy for 10 mins |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients falling under LASKINS criteria |
|
| ExclusionCriteria |
| Details |
Patients with degenerative changes of TMJ such as Flattening of condyle , Surface Erosion, Ely Cyst, sclerosis , osteophyte etc on OPG are Excluded
Patients with open facial wound, cardiac pacemaker, metal implant in craniofacial region.
Patients with associated odontogenic pain
Patients previously treated with ultrasound, TENS or phonophoresis for TMJ disorder
Patients with malignancy, mentally compromised are Excluded
Patients who are pregnant and lactating mothers are Excluded
Patients with any developmental disturbances of TMJ are Excluded
Patients with diclofenac allergy.
Patients with neuralgia, neuromuscular disorder like parkinson, myasthenia gravis etc disorder are Excluded.
Patients with any skin diseases or skin allergy are excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In patients with myofascial pain dysfunction syndrome there is decreased in VAS score and increased mouth opening with phonopheresis ,ultrasound and TENS |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the effectiveness of phonopheresis is better than ultrasound and TENS therapy. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
17/07/2025 |
| 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="1"
Months="6"
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
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Jhanvishah969@gmail.com].
- For how long will this data be available start date provided 14-06-2025 and end date provided 14-06-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Myofascial
pain dysfunction syndrome (MPDS) can be defined as “a local myofascial pain
condition characterized by local areas of firm; hypersensitive bands of muscle
tissue known as trigger points” also known as Myofascial trigger point pain. To
compare and evaluate the efficiency of transcutaneous electric nerve
stimulation, therapeutic ultrasound and phonophoresis in MYOFASCIAL PAIN
DYSFUNCTION SYNDROME 1.To
identify the prevalence of MPDS in different age groups and gender.
2.To
evaluate the effectiveness of TENS over ultrasound in MPDS.
3.To
evaluate the effectiveness of TENS over phonophoresis in MPDS.
4.To
evaluate the effectiveness of ultrasound over phonophoresis in MPDS |