| CTRI Number |
CTRI/2024/05/067997 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Investigating how a special super inductive magnetic device can help ease muscle pain caused by Myofasical Pain Ssyndrome (MPS). |
|
Scientific Title of Study
|
Isolation effect of Functional Magnetic Stimulator (FMS) on Myofascial Pain Syndrome (MPS). |
| 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. Shilpa Jain |
| Designation |
Associate Professor |
| Affiliation |
Delhi Pharmaceutical Science And Research University |
| Address |
Room no. 604, 6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, 110017
South
DELHI
110017
India |
| Phone |
7060443388 |
| Fax |
|
| Email |
shilpa.jain36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreya Mishra |
| Designation |
Post Gradute Student |
| Affiliation |
Delhi Pharmaceutical Science And Research University |
| Address |
Room No.C-5,PG Building, DPSRU Girls Hostel,Delhi Pharmaceutical Sciences and Research University Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, 110017
South
DELHI
110017
India |
| Phone |
7060443388 |
| Fax |
|
| Email |
shreyamishra988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shilpa Jain |
| Designation |
Associate Professor |
| Affiliation |
Delhi Pharmaceutical Science And Research University |
| Address |
Room no.604, 6th Floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, 110017
South
DELHI
110017
India |
| Phone |
7060443388 |
| Fax |
|
| Email |
shilpa.jain36@gmail.com |
|
|
Source of Monetary or Material Support
|
| School Of Physiotherapy, Delhi Pharmaceutical Sciences and Research University Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, 110017
|
|
|
Primary Sponsor
|
| Name |
School Of Physiotherapy Delhi Pharmaceutical Science And Research University |
| Address |
6th floor School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, 110017 |
| Type of Sponsor |
Research institution |
|
|
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 Shilpa Jain |
School Of Physiotherapy, OPD |
OPD, Ground floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi 110017
South
DELHI |
7060443388
shilpa.jain36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Students Research Development Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M791||Myalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Treatmment |
For subjects receiving Conventional Treatment:
Hot Fomentation:- 10 mins
Stretching of Trapezius muscle
Ultrasound Therapy: 1.2 W/cm2
Frequency: 1 MHz
Mode: Continuous.
Duration:-For 3 days/week for 3 weeks.
Subject will be assesed on baseline assessment and final assesment. |
| Intervention |
Functional Magnetic Stimulator |
For subjects receiving Functional Magnetic Stimulation:
The super inductive stimulator (the BTL-6000 Super Inductive System, by BTL Industries Ltd.) will be used to perform the therapy.
Duration:- For 3 days/week for 3weeks.
Subject will be assesed on baseline assessment and final assesment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
In order to participate in the study, individuals must experience both an active trigger point in the upper trapezius muscle and mechanical pain in the cervical region that has lasted for less than three months. Additionally, the pain intensity in the neck and cervical regions should be moderate, ranging from 3 to 8 on a Visual Analogue Scale (VAS) taken within the past 30 days, and the Neck Disability Index score should fall between 15 and 34 (inclusive). |
|
| ExclusionCriteria |
| Details |
Individuals with the following conditions will be excluded from the study: radicular syndrome (pain radiating down the arm), whiplash injury, or any diagnosed cervical pathology like a herniated disc. Additionally, those currently receiving treatment for neck or shoulder pain, using pain medication (analgesics, anti-inflammatory drugs, muscle relaxants), anticoagulant medications, or having a history of psychological/psychiatric conditions, active cancer, or who have undergone invasive spinal procedures within the last 4-6 months will not be eligible to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce pain and improvement in range of motion. |
Baseline
After 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in functional mobility. |
Baseline
After 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/06/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study will compare two group for pain relief. Both groups will receive treatment for 3 days per week for 3 weeks. 1. For subjects receiving Functional Magnetic Stimulation (FMS) will be delivered using the super inductive stimulator (The BTL-6000 Super Inductive System, by BTL Industries Ltd.) for 10 minutes with an acute analgesic protocol. 2. For subjects receiving conventional treatment will include hot fomentation for 10 minutes, stretching of the trapezius muscle, and continuous ultrasound therapy at 1 MHz and 1.2 W/cm2. |