CTRI

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CTRI Number

CTRI/2025/05/087634 [Registered on: 26/05/2025] Trial Registered Prospectively

Last Modified On:

23/05/2025

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

Study to compare the effect of blood flow restriction training and russian current along with resistance exercises in reducing pain and improving function in early knee osteoarthritis.

Scientific Title of Study

Efficacy of Blood flow restriction training and Russian current in conjugation with Resistance training in alleviating symptoms in early knee 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.Bhavna Verma PT
Designation	PG Scholar(MPT)
Affiliation	Uttar Pradesh University of Medical Sciences, Saifai, etawah, UP
Address	UPUMS,Saifai,Etawah, UP. Etawah UTTAR PRADESH 206130 India
Phone	8755512277
Fax
Email	vbhavna632@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Neha Dubey
Designation	Assistant Professor
Affiliation	Uttar Pradesh University of Medical Sciences, Saifai, etawah, UP
Address	Department of Physiotherapy UPUMS,Saifai,Etawah, UP. Etawah UTTAR PRADESH 206130 India
Phone	6395822600
Fax
Email	physioneha04@gmail.com

Details of Contact Person
Public Query

Name	Bhavna Verma
Designation	PG Scholar(MPT)
Affiliation	Uttar Pradesh University of Medical Sciences, Saifai, etawah, UP
Address	Department of Physiotherapy,UPUMS,Saifai,Etawah, UP. Etawah UTTAR PRADESH 206130 India
Phone	8755512277
Fax
Email	vbhavna632@gmail.com

Source of Monetary or Material Support

uttar Pradesh university of Medical Sciences,Saifai,Etawah.-206130

Primary Sponsor

Name	Uttar Pradesh University Of Medical Sciences
Address	UPUMS,Saifai,Etawah 206130 INDIA 91
Type of Sponsor	Other [Government Medical University]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Bhavna Verma PT	Uttar Pradesh University of Medical Sciences,Saifai,Etawah, UP.	Department of Physiotherapy and Department of orthopaedics,Room no.7,10. UPUMS,Saifai,Etawah-206130 Etawah UTTAR PRADESH	8755512277 vbhavna632@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Commitee Uttar Pradesh University Of Medical Sciences,Saifai,Etawah.	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M170\|\|Bilateral primary osteoarthritis of knee,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Blood flow restriction training and russian current	Experimental group (n=57) participants will be given BFRT with resistance training. BFRT will be given for 15 mins. The cuff then applied at proximal thigh after measuring the blood pressure of the patient and accordingly we apply pressure according to the (Australian sports 9 commission guidelines) and along with resistance training will be given, A total of 4 sets will be given consecutively as 30,15,15 and 15 at an interval of 3 minutes for tissue reperfusion. including Resistance training such as leg extensions with wt. cuff in sitting and a prescribed home exercise program. Frequency Session – 3 Sessions per week for 4 weeks.
Comparator Agent	Russian Current with Resistance Training.	Control group (n=57) participants will be given Russian current: Electrode placement -1 large electrode is placed on proximal part of quadriceps and 1 large electrode on the distal part (above knee), the placement should cover bulk of the muscle. A Wave form of symmetrical biphasic will be given with of Burst frequency (50 Hz) for the duration of 15 minutes per session Resistance training such as leg extensions with wt. cuff in sitting position and a prescribed home exercise program. Frequency- 3 sessions per week for 4 weeks.

Inclusion Criteria

Age From	45.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Age group: 45 to 70 yrs 2. Patient with both unilateral and bilateral knee pain. 3. Patients in early phase: Grade 1 and 2, According to Kellgren Lawrence classification 4.No contraindication to physical activity or electrical stimulation. 5. Both male and Female.

ExclusionCriteria

Details

Metabolic bone disorders.
2. Use of corticosteroids or local injections for knee OA in past 6 months.
3. Skin diseases.
4.Patient with cardiovascular diseases.
5.Patient with other arthritis like RA.
6.Patients with bony ankylosis.
7.Neuropathic joint diseases.
8. History of trauma.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Pain intensity,Range of motion, muscle strength,functional disability.	At Baseline,at 4 weeks and 8 weeks.

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="114"
Sample Size from India="114"
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)

04/06/2025

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="6"
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 investigates the comparative efficacy of Blood Flow Restriction Training (BFRT) and Russian current therapy, each combined with resistance training and a home exercise program, in patients with early knee osteoarthritis (OA). Participants aged 45–70 years with Grade 1 or 2 knee OA (per Kellgren-Lawrence classification) will be recruited from the Orthopaedics OPD at UPUMS, Safai. A total of 114 participants will be randomly assigned to two groups (n=57 each) using computer-generated randomization.

Intervention Protocols:
Group A will receive BFRT with resistance training, performed three times per week for 4 weeks, using pressure based on Australian Sports Commission guidelines. Group B will receive Russian current (50 Hz, 15 mins) with similar resistance training. Both groups will also follow a standardized home exercise program including quadriceps drills, hamstring curls, and stretching, with hot fomentation post-exercise.

Outcome Measures:
Baseline and post-intervention assessments at 4 weeks and 2-week follow-up will include pain (NRS, algometer), range of motion (digital goniometer), muscle strength (MMT), and functional disability (WOMAC). Validity and reliability of all outcome tools are well-established.

Statistical Analysis:
Data will be analyzed using SPSS software. Independent t-tests and ANOVA will determine the significance of differences between groups.

Hypothesis:
The alternative hypothesis suggests a significant difference in outcomes between BFRT and Russian current interventions, while the null hypothesis posits no significant difference.

Novelty:
This study is novel in its direct comparison of BFRT and Russian current combined with resistance training in early knee OA. It emphasizes early-stage intervention, integrates both objective and subjective outcomes, and has the potential to inform clinical guidelines for preventive OA management.