| CTRI Number |
CTRI/2024/06/068987 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Medicine versus physiotherapy machine treatment for muscle pain of face. |
|
Scientific Title of Study
|
Comparative assessment of efficacy of transcutaneous electrical nerve stimulation versus pharmacotherapy (drug combination of ibuprofen 400 mg, paracetamol 325 mg, chlorzoxazone 250 mg) in the treatment of patients with myofascial pain- A prospective randomised controlled 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 |
Shah Nida Mujibur Rahman |
| Designation |
Post Graduate student |
| Affiliation |
Government Dental College & Hospital Mumbai |
| Address |
Government Dental Mumbai, Department of Oral Medicine and Radiology, Ground floor, Room no. 23.Chhatrapati Shivaji Terminus Area, Fort, Mumbai, Maharashtra 400001
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9167418119 |
| Fax |
|
| Email |
snida214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sonali Kadam |
| Designation |
Post Graduate student |
| Affiliation |
Government Dental College & Hospital Mumbai |
| Address |
Room no 23, Department of Oral Medicine, Government Dental College, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
|
| Fax |
|
| Email |
sonalikdm863@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shah Nida Mujibur Rahman |
| Designation |
Post Graduate student |
| Affiliation |
Government Dental College & Hospital Mumbai |
| Address |
Government Dental College & Hospital Mumbai, Department of Oral Medicine & Radiology, Room no 23, Chhatrapati Shivaji Terminus Area, Fort, Mumbai 400001
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9167418119 |
| Fax |
|
| Email |
snida214@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College & Hospital Mumbai, Department of Oral Medicine & Radiology, Room no 23, Chhatrapati Shivaji Terminus Area, Fort, Mumbai 400001 |
|
|
Primary Sponsor
|
| Name |
Dr Shah Nida Mujibur Rahman |
| Address |
Government Dental College & Hospital Mumbai, Department of Oral Medicine & Radiology, Room no 23, Chhatrapati Shivaji Terminus Area, Fort, Mumbai 400001 |
| 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 Shah Nida Mujibur Rahman |
Government Dental College & Hospital Mumbai |
Government Dental College & Hospital Mumbai, Department of Oral Medicine & Radiology, Room no 23, Chhatrapati Shivaji Terminus Area, Fort, Mumbai 400001
Mumbai
MAHARASHTRA |
9167418119
snida214@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Government Dental College & Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of non steroidal anti inflammatory drugs and muscle relaxant |
Combination of Ibuprofen 400 mg,
Paracetamol 325 mg and Chlorzoxazone 250 mg.
Twice a day after meal for 7 days |
| Comparator Agent |
Transcutaneous electrical nerve stimulation therapy |
Transcutaneous electrical nerve stimulation therapy
15 to 20 mins
Twice in a week for 4 weeks
8 sittings
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender above 21 years of age.
2. Patients having complaint of masticatory muscle pain.
3. Pain and tenderness in the masticatory muscles on palpation.
4. Patients who have not received any treatment for Myofascial pain, 3 months before the
research participation. |
|
| ExclusionCriteria |
| Details |
1. Pain of non-muscular origin (Dental, vascular or neural).
2. Patients presenting with tenderness of temporomandibular joint on palpation.
3. Completely edentulous patients or multiple missing teeth.
4. Patients having epileptic attacks and seizures.
5. Patients of known case of peptic ulcer.
6. Patients mentally retarded or having neuromuscular problem.
7. Patients on pacemakers, cochlear implants or metallic implants (as TENS can alter or adversely
affect the function of pacemakers).
8. Patients with cardiac abnormalities (TENS can modify the cardiac impulse).
9. Pregnant patients (TENS is contraindicated because it can cause preterm labour).
10. Patients showing any allergy to lubricating gel used in TENS therapy.
11. Patients with known allergy to chlorzoxazone, ibuprofen, paracetamol will be excluded.
12. Patients who do not give informed consent will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mouth opening (measurement of interincisal distance in mm)
2. VAS score (using visual analogue scale ranging 0-10)
3. Clicking sound (whether present or absent Y/N) |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects and recurrence of pain |
Once in a month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/06/2024 |
| 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="6" |
|
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
|
Myofascial pain is a chronic condition that causes pain in musculoskeletal system. The pain is confined to the
particular area and is typically associated with trigger point in muscle. These trigger points radiate pain to
the affected area when a pressure is applied to them and sometimes with no pressure. The myofascial pain
is characterized by myofascial trigger points and fascial constrictions.
1 A multimodality approach is required
to treat myofascial pain as the condition’s etiology is variable. Various treatment methods include muscle
relaxants, doing jaw stretching exercises, applying ultrasound, TENS, and shortwave diathermy. TENS is a
technique that passes electrical currents across the intact surface of the skin to activate underlying nerves.
This consists of a battery-powered handheld stimulating device which generates pulsed electrical currents
which are delivered through the skin using the electrode pads attached to the skin surface and hence relieve
the pain. Pharmacotherapy including use of combination drugs of NSAIDs and centrally acting muscle
relaxants is one of the treatment modality to relieve the pain.
2 While TENS and Pharmacotherapy are
proven to be effective in relieving muscular pain, there are limited studies pertaining to the treatment of
Myofascial pain that compares the effectiveness of these two modalities.The goal of this study is to compare
the efficacy of these methods in treating Myofascial pain. |