| CTRI Number |
CTRI/2025/02/080696 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to assess the Effectiveness of Facial Gun Massaging Therapy and Transcutaneous Electrical Nerve Stimulation for Myofascial Pain Dysfunction Syndrome Patients |
|
Scientific Title of Study
|
A Comparative Study of Facial Gun Massaging Therapy and Transcutaneous Electrical Nerve Stimulation as an adjunct to Pharmaceutical Therapy for Myofascial Pain Dysfunction Syndrome: A Randomised Clinical 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 Shai Keerthana K |
| Designation |
postgraduate |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology, Karpaga Vinayaga Institute of Dental Sciences,G.S.T Road, Chinna kolambakkam, Palayanoor post, Madhuranthagam Taluk, Chengalpattu, Tamilnadu-603308
Kancheepuram
TAMIL NADU
620010
India |
| Phone |
9677630142 |
| Fax |
|
| Email |
shaikeerthana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R R Mahendra Raj |
| Designation |
Senior Professor and Head of the Department |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology, Karpaga Vinayaga Institute of Dental Sciences,G.S.T Road, Chinna kolambakkam, Palayanoor post, Madhuranthagam Taluk, Chengalpattu, Tamilnadu-603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9789055848 |
| Fax |
|
| Email |
drmahendraraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R R Mahendra Raj |
| Designation |
Senior Professor and Head of the Department |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology, Karpaga Vinayaga Institute of Dental Sciences,G.S.T Road, Chinna kolambakkam, Palayanoor post, Madhuranthagam Taluk, Chengalpattu, Tamilnadu-603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9789055848 |
| Fax |
|
| Email |
drmahendraraj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute of dental Sciences, Department of Oral Medicine and Radiology, Ground floor, Division of Dental Hospital Road, Chinnakolambakkam, Madhuranthagam taluk, Palayanoor post, Chengalpattu-603308 |
|
|
Primary Sponsor
|
| Name |
Dr. Shai Keerthana K |
| Address |
Karpaga Vinayaga Institute of dental Sciences, Department of Oral Medicine and Radiology, Ground floor, Division of Dental Hospital Road, Chinnakolambakkam, Madhuranthagam taluk, Palayanoor post, Chengalpattu-603308 |
| 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 Shai Keerthana K |
Karpaga Vinayaga Institute of Dental Sciences |
Karpaga Vinayaga Institute of Dental Sciences, Department of Oral Medicine and Radiology, Room No 4, Ground floor, Division of Dental Hospital Road, Chinnakolambakkam, Madhuranthagam taluk, Palayanoor post, Chengalpattu-603308
Kancheepuram
TAMIL NADU |
9677630142
shaikeerthana@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Facial Gun Massaging Therapy+ Pharmacotheray |
Group 2: 20 Patients; receive facial gun massaging therapy along with Pharmacotherapy TAB. MYOSPAS FORTE 0-0-1 for 1week through oral route; (Chlorzoxazone 500mg + Diclofenac Potassium 50mg + Paracetamol 325mg). Facial gun is used at a frequency of 30 Hz for 15 minutes given Biweekly for 5 weeks (10 sessions) |
| Comparator Agent |
Pharmacotherapy alone |
Group 1: 20 Patients; receive Pharmacotherapy alone TAB. MYOSPAZ FORTE 0-0-1 for 1week through oral route (Chlorzoxazone 500mg + Diclofenac Potassium 50mg + Paracetamol 325mg). |
| Comparator Agent |
Transcutaneous Electrical Nerve Stimulation + Pharmacotherapy |
Group 3: 20 Patients; receive Transcutaneous Electrical Nerve Stimulation along with Pharmacotherapy TAB. MYOSPAS FORTE 0-0-1 for 1week through oral route; (Chlorzoxazone 500mg + Diclofenac Potassium 50mg + Paracetamol 325mg). Transcutaneous Electrical Nerve Stimulation is used 180 Hz, 20 minutes given Biweekly for 5 weeks (10 sessions) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 to 60 years.
2.Pain on palpation in masticatory muscles
3.Normal posterior occlusion.
4.Suffering from orofacial pain for a minimum of 1 months
|
|
| ExclusionCriteria |
| Details |
1.Presence of TMD with joint origin
2.Neuropathic pain.
3.Systemic diseases such as cardiovascular disorders, infectious diseases, inflammatory diseases, epilepsy, tumors, or mental illnesses which could affect the clinical picture of patients,
4.Removable denture, missing of more than one tooth in each quadrant,
5.Major malocclusion (anterior open bite, maxillary unilateral lingual cross-bite, and overjet greater than 6 mm)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparing the effectiveness of facial gun and TENS as an adjunct to Pharmaceutical Therapy for Myofascial Pain Dysfunction Syndrome patients.
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the pain in Group 2 MPDS patients undertaking Facial Gun Massaging Therapy as an adjunct to Pharmaceutical Therapy. |
2 months |
| To assess the pain in Group 3 MPDS patients undertaking Transcutaneous Electrical Nerve Stimulation as an adjunct to Pharmaceutical Therapy. |
2 months |
| To assess the pain in Group 1 MPDS patients undertaking Pharmaceutical Therapy alone. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
Modification(s)
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Patients with Myofascial Pain Dysfunction Syndrome who visit the Department of Oral Medicine and Radiology at Karpaga Vinayaga Institute of Dental Sciences undergo a thorough case history recording and clinical examination, followed by pain assessment using a visual analog scale and electromyography. Patients will be grouped into 1, 2 or 3 using simple random sampling, Group 1: 20 Patients; receive Pharmacotherapy alone TAB. MYOSPAZ FORTE 0-0-1 for 1week (Chlorzoxazone 500mg + Diclofenac Potassium 50mg + Paracetamol 325mg). Group 2: 20 Patients; receive facial gun massaging therapy along with Pharmacotherapy TAB. MYOSPAS FORTE 0-0-1 for 1week; (Chlorzoxazone 500mg + Diclofenac Potassium 50mg + Paracetamol 325mg). Facial gun is used at a frequency of 30 Hz for 15 minutes given Biweekly for 5 weeks (10 sessions) Group 3: 20 Patients; receive Transcutaneous Electrical Nerve Stimulation along with Pharmacotherapy TAB. MYOSPAS FORTE 0-0-1 for 1week; (Chlorzoxazone 500mg + Diclofenac Potassium 50mg + Paracetamol 325mg). Transcutaneous Electrical Nerve Stimulation is used 180 Hz, 20 minutes given Biweekly for 5 weeks (10 sessions) Visual analog scale, electromyography and mouth opening recordings will be taken before and after each session. The treatment will continue 5 weeks as two sessions per week. Data analysis: Data from visual analog scale and electromyography will be compiled using MS excel software and data analysis will be done using Statistical Package for Social Sciences Software version 20s Outcome Variable: Decreased pain intensity, VAS pain score, increased muscle tone. |