| CTRI Number |
CTRI/2025/11/097411 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| 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
|
Treatment for pain in osteoarthritis |
|
Scientific Title of Study
|
Effect of Blood Flow Restriction Training on pain , muscle strength , knee mechanics and functional outcomes in women with tibiofemoral osteoarthritis- a randomised 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 |
Dr Vaishnavi Raut PT |
| Designation |
Assistant Professor , Ph.D Scholar |
| Affiliation |
Dr. D. Y Patil College of Physiotherapy |
| Address |
Gopika Park , Juna Khandai Road , Digras . Dist - Yavatmal
Dr. D.Y Patil College of Physiotherapy , Sant Tukaram Nagar ,Pimpri , Pune
Pune
MAHARASHTRA
445203
India |
| Phone |
9552190103 |
| Fax |
|
| Email |
rautavaishnavi63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Saini |
| Designation |
Professor |
| Affiliation |
Dr. D. Y Patil College of Physiotherapy ,Pune |
| Address |
Room no. 2 , 3rd floor , Musculoskeletal department
Dr. D. Y Patil college of Physiotherapy , Sant Tukaram Nagar , Pimpri ,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seema.saini@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Saini |
| Designation |
Professor |
| Affiliation |
Dr. D. Y Patil College of Physiotherapy ,Pune |
| Address |
Room no. 2 , 3rd floor , Musculoskeletal department
Dr. D. Y Patil college of Physiotherapy , Sant Tukaram Nagar , Pimpri ,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seema.saini@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y Patil College of Physiotherapy ,Pune -411018, Maharashtra ,India |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College of Physiotherapy Pune |
| Address |
room no 2, 3rd floor, musculoskeletal department.Dr. D Y Patil college of physiotherapy ,Pune - 411018, Maharashtra , India |
| 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 Vaishnavi Raut |
Dr. D Y Patil College of Physiotherapy |
Room no. 2 Musculoskeletal Department ,Dr. D.Y Patil college of physiotherapy , Pune
Pune
MAHARASHTRA |
9552190103
rautavaishnavi63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Dr. D.Y Patil College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood flow restriction training (BFRT) |
exercises given along with Blood Flow R restriction cuff - isometrics to quadtriceps . High sitting knee extension ,straight leg raise , straight leg abduction , hamstring curl
Frequency - 2- 3 days per week
Intensity - 40-50% of 1 RM
Time - 30-40 mins
Sets - 1-2 sets with 2-3 mins rest period in between sets .(10-15 repitations ) |
| Comparator Agent |
normal exercise program without Blood Flow R restriction cuff |
isometrics to quadriceps , high sitting knee extension , straight leg raise , straight leg abduction , hamstring curl .
Frequency- 2-3 days per week
Intensity- 40-50 % of 1 RM
Time - 30 -40 mins
Sets - 1-2 sets with 2-3 mins rest in between sets(10-15 repitations). |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
women from 40 - 60 years of age, Daignosed case of grade 1& 2 osteoarthritis according to kellegren & lawrence grading , symptomatic knee osteoarthritis, unilateral or bilateral knee osteoarthritis, willing to participate , mild to moderate pain on VAS |
|
| ExclusionCriteria |
| Details |
Any known cardiovascular conditions , high blood pressure , history of fracture or other musculoskeletal disorder on the lower extremity ,Participants undergone any knee surgery to either knee in recent months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale , 1 RM, Motion Analysis software , WOMAC modified (Pune version) |
At baseline , after 3 weeks , after 6 weeks and after 10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tempa scale of Kinesiophobia |
At baseline , after 3 weeks , after 6 weeks & after 10 weeks. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/01/2026 |
| 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="3"
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
|
This study is Randomized ,Double blind, Parallel group trial.where participants will be randomly assigned to two groups . Intervention group will receive Blood Flow Restriction training along with conventional exercise and control group will receive only exercise . Primary outcome measure is Visual Analogue scale, 1 repitation maximum (RM), Kinovea motion analysis software , WOMAC scale and secondary outcome measure is Tempa Scale of kinesiophobia |