| CTRI Number |
CTRI/2026/01/100197 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| 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
|
A study in people with knee arthritis to see how two different exercise methods affect pain, physical function, and thigh muscle strength. |
|
Scientific Title of Study
|
Comparative Study On Effectiveness Of Blood Flow Restriction Training With Low Load Resistance Training VS Neuromuscular Electrical Stimulation With Low Load Resistance Training On Pain, Function, Quadricep Strength In Knee Osteoarthritis |
| 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 Riya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Room No 10, R D Block, 1st Floor, MG Physiotherapy College,
MGUMST Campus, RIICO Industrial Area, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
08824133872 |
| Fax |
|
| Email |
DRRIYAGUPTA78@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Room No 10, R D Block, 1st Floor, MG Physiotherapy College,
MGUMST Campus, RIICO Industrial Area, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
08824133872 |
| Fax |
|
| Email |
DRRIYAGUPTA78@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Room No 10, R D Block, 1st Floor, MG Physiotherapy College,
MGUMST Campus, RIICO Industrial Area, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
08824133872 |
| Fax |
|
| Email |
DRRIYAGUPTA78@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Physiotherapy College |
| Address |
Mahatma Gandhi University of Medical Sciences and Technology Campus, RIICO Institutional Area, Sitapura, Jaipur, Rajasthan, INDIA 302022 |
| 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 |
| Dr Madhusudan Tiwari |
Physiotherapy OPD & Othopedics Dept. of MG Hospital, Mahatma Gandhi Physiotherapy College, |
Department of Physiotherapy and Orthopaedics, Mahatma Gandhi Hospital, Mahatma Gandhi University of Medical Sciences and Technology Campus, RIICO Institutional Area, Sitapura, Jaipur – 302022
Jaipur
RAJASTHAN |
8290964159
madhusudan1977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BFRT |
Blood Flow Restriction Training With Low Load Resistance Exercise For 8 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Clinical and radiographic diagnosis of Knee Osteoarthritis (KOA) Grade I by Orthopaedician. |
|
| ExclusionCriteria |
| Details |
Advanced knee OA (Kellgren-Lawrence Grade IV), History of recent trauma or surgery affecting the lower extremity in the past 6 months, Neurological or musculoskeletal disorders affecting gait or balance, Severe cardiovascular or pulmonary disease, Known thromboembolic disorders or deep vein thrombosis (DVT), Open wounds, skin infections, or dermatological conditions on the thigh/knee, Use of anticoagulant therapy, Severe Osteoporotic Conditions, History of Epilepsy or Seizure Disorders, Presence Of Cognitive Impairment or Psychiatric Illness, Presence of implanted electrical devices (for NMES group), Pregnancy or lactation, Participation in another clinical trial within the last 30 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quadriceps muscle strength will be assessed at baseline (0 weeks), after 4 weeks, and at the end of 8 weeks. |
At 0 weeks, at 4 weeks, and at 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical function will be assessed using the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) scale at baseline (0 weeks), after 4 weeks, & at the end of 8 weeks. |
At 0 weeks, at 4 weeks, & at 8 weeks. |
| Pain intensity will be assessed using the Visual Analogue Scale (VAS) at baseline (0 weeks), after 4 weeks, & at the end of 8 weeks. |
At 0 weeks, at 4 weeks, & at 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
13/01/2026 |
| 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="2"
Months="0"
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
|
Knee osteoarthritis (OA) leads to pain, reduced function, and quadriceps weakness, worsening joint stability and mobility. High-load resistance training improves strength but may increase joint pain in OA patients. Blood Flow Restriction (BFR) with low-load training offers similar strength gains with less joint stress, while Neuromuscular Electrical Stimulation (NMES) also improves strength and reduces pain in those unable to perform intense exercise. A direct comparison of BFR+LLRT vs NMES+LLRT is limited, justifying the need for this study. |