| CTRI Number |
CTRI/2025/04/084900 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| 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
|
Comparative Effects of IASTM and Neuromuscular Inhibition on Hamstring Tightness |
|
Scientific Title of Study
|
Comparative analysis of instrument-assisted soft tissue mobilization and integrated neuromuscular inhibition technique in patients with hamstring tightness |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| U1111-1324-4049 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anchal Thakur |
| Designation |
PG Student |
| Affiliation |
|
| Address |
Room no 3, Ground Floor,
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7876014074 |
| Fax |
|
| Email |
anchalthakur78760@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanika Bhatia |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Room no 3, Ground Floor,
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7807186627 |
| Fax |
|
| Email |
kanika.bhatia@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Kanika Bhatia |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Room no 3, Ground Floor,
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7807186627 |
| Fax |
|
| Email |
kanika.bhatia@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana-133207 |
|
|
Primary Sponsor
|
| Name |
Anchal Thakur |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala-Haryana-133207 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kanika Bhatia |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana,
Ambala-Haryana-133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anchal Thakur |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room no 3, Ground Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (DEEMED TO BE) University, Mullana
Ambala-Haryana-133207
Ambala
HARYANA |
7876014074
anchalthakur78760@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research Mullana, Ambala, Communication of Decision of the 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 |
Group 1 (IASTM) |
Participants will be divided into two groups. Group A received instrument-assisted soft tissue mobilization (IASTM), where stainless steel tool were used to apply controlled strokes along the hamstring muscle to reduce tightness and improve flexibility. Treatment lasted 5-7 minutes per session, followed by light stretching, delivered 2-3 times per week over a 3-4 week period. |
| Comparator Agent |
Group 2 (INIT) |
Group B received the Integrated Neuromuscular Inhibition Technique (INIT), which combined ischemic compression, positional release technique, and muscle energy technique. This involved applying manual pressure to tender points, positioning the muscle in a shortened position, and using gentle isometric contractions to facilitate muscle lengthening. Both groups were assessed pre and post-intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Lack of at least twenty degrees of knee extension during the supine Active Knee Extension test, and a passive Straight Leg Raise angle of seventy-five degrees or less
2. Reduced pain pressure threshold
3. Individuals with Numeric Pain Rating Scale score equal to or more than four
4. No current involvement in hamstring stretching or rehabilitation programs
|
|
| ExclusionCriteria |
| Details |
1. Acute and chronic low back pain patients
2. Recent fracture in lower limb more than six months
3. Any neurological or orthopedic conditions that could affect mobility or muscle function
4. Soft tissue injuries around the knee
5. Unilateral or bilateral radiating symptoms from the back or sciatic nerve damage, complaining of neurological symptoms during SLR test
6. Hematoma, varicose vein and skin infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numeric Pain Rating Scale (NPRS)
2. Universal Goniometer
3. SF- 36 Questionnaire
4. Pain Pressure Threshold by Algometer
|
At pre-intervention (Baseline)and Post-intervention after 8 sessions in 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
18/02/2026 |
| Date of First Enrollment (Global) |
01/05/2025 |
| Date of Study Completion (Global) |
18/02/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Hamstring tightness is a common musculoskeletal condition that affects both the athletic and general population, often leading to restricted flexibility, reduced range of motion, and an increased risk of injury. Flexibility is an important physiological component of physical fitness. Instrument-assisted soft tissue mobilization (IASTM) is a form of manual therapy that uses specialized tools to manipulate soft tissues, including muscles, fascia, tendons, and ligaments. It is a technique that involves using instruments to address musculoskeletal pathology-related impairments, and the Integrated neuromuscular inhibition technique (INIT) is a comprehensive therapeutic approach that improves neuromuscular function and reduces muscle tightness by combining multiple manual therapy techniques to heal soft tissues. UTN: U1111-1324-4049 |