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CTRI Number  CTRI/2025/07/090912 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
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   Exercise and Electrical Therapy to Reduce Knee Pain and Improve Strength in Older Adults 
Scientific Title of Study   Effects of Russian Electrical Stimulation-enhanced Quadriceps Strengthening Exercise on Pain, Muscle Strength and Functional Outcomes in Older Adults with 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  Jakia Sultana 
Designation  Undergraduate Student 
Affiliation  Jashore University of Science and Technology 
Address  Room no: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801726969910  
Fax    
Email  jakiasultana8656@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ehsanur Rahman 
Designation  Assistant Professor  
Affiliation  Jashore University of Science and Technology 
Address  Room no: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801716062263  
Fax    
Email  e.rahman@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Ehsanur Rahman 
Designation  Assistant Professor  
Affiliation  Jashore University of Science and Technology 
Address  Room no: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801716062263  
Fax    
Email  e.rahman@just.edu.bd  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408 
 
Primary Sponsor  
Name  Dr Ehsanur Rahman 
Address  Room no: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Kabir Hossain  Dr M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408  Level-3, Room no: 301, Musculoskeletal Lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology

 		 8801778315139

kabir2002pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy & Rehabilitation, JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Quadriceps Strengthening Exercise  Participants in the control group will receive standard quadriceps strengthening exercises. This will include isometric quadriceps exercises consisting of three sets of ten repetitions each, with each contraction held for five seconds and a rest period of two minutes between sets. In addition to the isometric exercises, progressive resistance strengthening will be carried out in three stages using Thera-Bands. In Stage 1, participants will perform three sets of ten repetitions with a yellow Thera-Band; in Stage 2, three sets of fifteen repetitions will be done with a red Thera-Band; and in Stage 3, three sets of twenty repetitions will be performed using a green Thera-Band. There will be a rest period of two minutes between sets. Participants will progress to the next stage once they are able to perform the current stage with proper technique for two consecutive sessions. All exercises will be performed in a supine or long sitting position with the knee extended. The strengthening program will be administered by a licensed physiotherapist for three sessions per week over a total period of six weeks.  
Intervention  Russian Electrical Stimulation with quadriceps strengthening  Participants in the experimental group will receive Russian electrical stimulation in addition to quadriceps strengthening exercises. Russian electrical stimulation will be applied to the quadriceps muscle with a pulse frequency of fifty Hertz, burst duration of ten milliseconds on and ten milliseconds off, and symmetric sinusoidal pulses with a pulse duration of four hundred microseconds. The duty cycle will be twenty-five percent, with five seconds on and twenty seconds off, at the maximum intensity tolerated by the participant. Each session will start with ten to fifteen muscle contractions, which will be progressively increased as tolerated. Electrodes will be placed over the quadriceps muscle belly and the appropriate motor points. Along with the electrical stimulation, participants will perform the same quadriceps strengthening exercises as the control group, which include isometric contractions and progressive resistance training with Thera-Bands in the same three stages. Exercises will be performed in a supine or long sitting position with the knee extended. The intervention will be provided by a licensed physiotherapist for three sessions per week over a total duration of six weeks. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Men and Women aged fifty years or above with knee pain rated eight or more on VAS, diagnosed with knee osteoarthritis for at least six months as per ACR criteria, able to walk without gait aids, knee flexion more than ninety degrees and willing for standing knee joint X ray. 
 
ExclusionCriteria 
Details  Participants will be excluded if they have had knee surgery in the past year, use implanted electrical devices, have recent contracture or trauma, or have neuromuscular or skin diseases affecting the lower limb. Those who have done strength training in the last six months, use anti-inflammatory analgesics, or received corticosteroid or hyaluronic acid injections within three months will also be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Pain by Pressure Pain Threshold with pressure algometer
2.Muscle Strength by Automated Portable Dynamometer 		 Baseline, after 6 weeks intervention, follow up after 3 months from post intervention analysis 
 
Secondary Outcome  
Outcome  TimePoints 
1.Functional Disability by WOMAC disability index and 6 Min Walk Test  Baseline, after 6 weeks intervention, follow up after 3 months from post intervention analysis 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="0" 
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 1 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [e.rahman@just.edu.bd].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized controlled trial will examine the effects of Russian Electrical Stimulation combined with Quadriceps Strengthening Exercise on pain, muscle strength, and functional outcomes in older adults with knee osteoarthritis. Men and women aged fifty years and above with knee pain rated eight or higher on the visual analog scale and diagnosed with knee osteoarthritis for at least six months will be eligible. Participants will be randomly assigned to either a control group receiving standard quadriceps strengthening exercises or an intervention group receiving Russian Electrical Stimulation along with isometric and progressive quadriceps strengthening using a Thera-band. Outcomes will include pressure pain threshold, muscle strength measured with an automated portable dynamometer, functional disability using the WOMAC Index, and the six-minute walk test. The study will be conducted at the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology with recruitment expected to begin on fifteenth July two thousand twenty-five. The study is partially funded by the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology. 
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