| CTRI Number |
CTRI/2025/06/089543 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| 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
|
Effect of Instrument assisted soft tissue mobilization on upper trapezius myofascial trigger point with stretching versus percussion therapy with stretching on upper trapezius myofascial trigger points a two week intervention study |
|
Scientific Title of Study
|
Effectiveness 0f Instrument-Assisted soft tissue mobilization [IASTM] versus Percussion therapy with stretching in the individuals having upper trapezius myofascial trigger points: A single blinded randomized control 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 Yogesh Sunil Khairmode |
| Designation |
1st year MPT (Musculoskeletal physiotherapy) |
| Affiliation |
Dr Vitthalrao Vikhe patil College Of Physiotherapy |
| Address |
Department of musculoskeletal physiotherapy basement Dr. Vitthalrao Vikhe patil college of Physiotherapy Vilad Ghat Ahmednagar
Ahmadnagar MAHARASHTRA 414111 India |
| Phone |
8291715939 |
| Fax |
|
| Email |
yogeshkhairmode17@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Syed Saqib |
| Designation |
Associate Professor Department of Musculoskeletal physiotherapy |
| Affiliation |
Dr Vitthalrao Vikhe patil College Of Physiotherapy |
| Address |
Department of musculoskeletal physiotherapy basement Dr. Vitthalrao Vikhe patil college of Physiotherapy Vilad Ghat Ahmednagar
Ahmadnagar MAHARASHTRA 414111 India |
| Phone |
7517410984 |
| Fax |
|
| Email |
saqibpt@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Syed Saqib |
| Designation |
Associate Professor Department of Musculoskeletal physiotherapy |
| Affiliation |
Dr Vitthalrao Vikhe patil College Of Physiotherapy |
| Address |
Department of musculoskeletal physiotherapy basement Dr. Vitthalrao Vikhe patil college of Physiotherapy Vilad Ghat Ahmednagar
MAHARASHTRA 414111 India |
| Phone |
7517410984 |
| Fax |
|
| Email |
saqibpt@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DVVPFS College of Physiotherapy Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DVVPFS College of Physiotherapy Ahmednagar |
| Address |
Dr. Vitthalrao Vikhe patil college of Physiotherapy Vilad Ghat Ahmednagar |
| 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 |
| Yogesh khairmode |
DVVPFS College of Physiotherapy |
Department of musculoskeletal physiotherapy basement block 1 DVVPF College of physiotherapy Ahmadnagar MAHARASHTRA |
8291715939
yogeshkhairmode17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committee Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrument Assisted soft tissue mobilization with stretching |
Subjects will receive instrument assisted soft tissue mobilization with stretching for 3 times per week for 2 weeks |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Percussion Therapy with Stretching |
Subjects will receive Percussion Therapy with Stretching for 3 times per week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
Presence of active myofascial trigger points in the upper trapezius muscle confirmed by palpation.
Reporting pain intensity of more than or equal to four on the Numeric Pain Rating Scale (NPRS).
no history of recent corticosteroid injections or surgery in the neck/shoulder region. |
|
| ExclusionCriteria |
| Details |
Presence of any neurological disorder affecting the cervical spine.
Recent trauma or fracture in the cervical or shoulder region.
Individuals undergoing concurrent alternative treatment e.g., acupuncture, chiropractic therapy.
Bilateral trigger points in upper trapezius |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric pain rating scale
Neck Disability Index
Cervical range of motion
Pressure pain threshold |
Baseline , 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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 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 syndrome (MPS) is a major contributor to musculoskeletal disorders, affecting millions worldwide. The upper trapezius is one of the most commonly affected muscles, often linked to poor posture, prolonged screen time, and repetitive strain. Traditional interventions such as massage, dry needling, and stretching have demonstrated efficacy, but there is a growing need for evidence-based, non-invasive techniques like Instrument-Assisted Soft Tissue Mobilization (IASTM). Recent advances in IASTM suggest that it can enhance myofascial release by stimulating mechanoreceptors, improving circulation, and modulating pain perception. Studies indicate that IASTM, when combined with stretching or percussion therapy, may yield superior outcomes in reducing muscle stiffness and improving functional mobility. However, there is a lack of consensus on the optimal treatment combination for managing upper trapezius MTrP, necessitating further research. Additionally, the increasing reliance on technology has led to a surge in cases of neck and shoulder pain, emphasizing the urgency of developing effective physiotherapeutic interventions. This study will compare the effectiveness of IASTM alone and in combination with stretching or percussion therapy. By identifying the most effective approach, this research will contribute to evidence-based rehabilitation strategies, ultimately improving patient outcomes and reducing the burden of musculoskeletal disorders. |