| CTRI Number |
CTRI/2025/04/085713 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can restained training ease pain and boost performance in college runners with shin pain |
|
Scientific Title of Study
|
Effect of Blood Flow Restriction Training on pain, agility and electromyographic Muscle activity among Collegiate Recreational runner with Medial Tibial Stress Syndrome: A Randomized 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 |
Sanghamitra Jena |
| Designation |
Research Scholar |
| Affiliation |
Lakshmibai National Institute of Physical Education |
| Address |
Room No NB2, Department of Sports Biomechanics,Lakshmibai National Institute of Physical Education,Sakti Nagar, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
09776961858 |
| Fax |
|
| Email |
sanghamitra.bpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanghamitra Jena |
| Designation |
Research Scholar |
| Affiliation |
Lakshmibai National Institute of Physical Education |
| Address |
Room No NB2, Department of Sports Biomechanics,Lakshmibai National Institute of Physical Education,Sakti Nagar, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
09776961858 |
| Fax |
|
| Email |
sanghamitra.bpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joseph Singh |
| Designation |
Professor |
| Affiliation |
Lakshmibai National Institute of Physical Education |
| Address |
Room No, Department of Sports Biomechanics,Lakshmibai National Institute of Physical Education,Sakti Nagar, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
7409081660 |
| Fax |
|
| Email |
josephsingh.2035@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University, Plot No 2, Sector 17A, Opposite Budha International Circuit, Gautam Buddha Nagar, Uttar Pradesh, India, 203201 |
|
|
Primary Sponsor
|
| Name |
Lakshmibai National Institute of Physical Education |
| Address |
Department of Sports Biomechanics,Lakshmibai National Institute of Physical Education,Sakti Nagar, Gwalior, Madhya Pradesh, India, 474002 |
| 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 Sanghamitra Jena |
Galgotias University |
Room No E003,Department of Physiotherapy, School of Allied health sciences, Galgotias University, Plot No 2,Sector 17A,Opposite Buddha International Circuit
Gautam Buddha Nagar
UTTAR PRADESH |
9776961858
sanghamitra.bpt@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: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood flow Restriction Training with low load resistant training |
Blood flow restriction training combined with low-load Resistance training (Resistance exercises include Plantar flexors, dorsiflexors, invertors and evertors by using theraband)4 set of 30-15-15-15 repetations, 3 sessions a week for 8 weeks |
| Comparator Agent |
Resistant Training Without Blood flow Restriction Training |
Standard physiotherapy care with Resistance training exercises for Plantar flexors, Dorsiflexors, invertors and evertors by using Theraband 4 sets 3 days a week for 8 weeks. After Gentle Warm up subjects will start low load resistance training. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
• both male and female age between 18-30 years.
• recreational runners experiencing symptoms for more than two weeks.
• Pain localized to anterior and posteromedial sides of the shin and local tenderness as I and II
• MTSS will be confirmed through physical test by One leg Hop test and Yate’s criteria.
|
|
| ExclusionCriteria |
| Details |
Individual with fracture in the lower limb, surgery around knee and ankle, bone pathology, deformities and any neurological disease will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Threshold-Algometer, Agility by T test,
Muscle Activity Of tibialis anterior and posterior- EMG |
Baseline and after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/05/2025 |
| 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="0"
Months="3"
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
|
This randomized controlled trial aims to investigate the effects of Blood Flow Restriction (BFR) training on pain, agility, and electromyographic (EMG) muscle activity in collegiate recreational runner diagnosed with Medial Tibial Stress Syndrome (MTSS). Eligible participants will be randomly assigned to either a BFR training group or a control group. The BFR group will undergo a structured low-load resistance training program with blood flow restriction applied to the lower limbs, while the control group will perform identical exercises without BFR. The intervention will be conducted over a specified duration, with pre- and post-intervention assessments. Outcome measures will include pain intensity (measured using an algometer), agility performance (evaluated through T tests), and EMG activity of TA and TP lower limb muscles. The study aims to determine whether BFR training can serve as an effective rehabilitation approach for MTSS by enhancing muscle function and reducing pain without excessive mechanical load. |