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CTRI Number  CTRI/2025/07/091244 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Helping Diabetic Nerve Pain: Foot Exercises vs. Electrical Treatment for Better Sleep and Everyday Activities 
Scientific Title of Study   Comparing the Effects of Foot Exercise v/s Electrical stimulation on Pain, Quality of Sleep and Community participation in Individuals with Diabetic Peripheral Neuropathy: 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  Ashmita Ashok Vernekar 
Designation  Postgraduate student 
Affiliation  SDM College of physiotherapy 
Address  OPD number 13, Community Physiotherapy Department, SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  07774904308  
Fax    
Email  ashmitavernekar99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ashmita Ashok Vernekar 
Designation  Postgraduate student 
Affiliation  SDM College of physiotherapy 
Address  OPD number 13, Community Physiotherapy Department, SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  07774904308  
Fax    
Email  ashmitavernekar99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Salima Mulla Bijapuri 
Designation  Professor, PG Guide  
Affiliation  SDM College of physiotherapy 
Address  OPD number 13, Community Physiotherapy Department, SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  7760580737  
Fax    
Email  drsalimamulla@gmail.com   
 
Source of Monetary or Material Support  
SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad, karnataka , India - 580009 
 
Primary Sponsor  
Name  Ashmita Ashok Vernekar  
Address  SDM College of medical sciences and hospital SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad 
Type of Sponsor  Other [Self ] 
 
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 Ashmita Ashok Vernekar  Shri Dharmasthala Manjunatheshwara hospital  CBR Physiotherapy Department OPD Number 13, Manjushree Nagar Sattur Dharwad Karnataka Dharwad KARNATAKA
Dharwad
KARNATAKA 
07774904308

ashmitavernekar99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - SDM College of Medical Sciences and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General diabetic care with exercises   General diabetic care with exercises like aerobic exercises such as walking, cycling,(20–30 mins, 3–5 times/week), resistance training (2–3 times/week), flexibility exercises such as stretching of leg muscles (3-5 times/week), along with foot care advice will be given which the patient can perform in home setup  
Intervention  Specific foot exercises for group A and transcutaneous electrical nerve stimulation for group B along with genereal diabetic care   Group A will receive general diabetic rehab and foot-specific exercises such as toe curls, ankle mobility, and calf stretches, performed thrice weekly for 4 weeks. Group B will receive general diabetic rehab and Transcutaneous electrical nerve stimulation, which is an electrical modality which provides pain relief and works on certain parameters like frequency, pulse duration and intensity according to Patients tolerance, given for 20 minutes, three times weekly to manage neuropathic pain. The intervention will take place for the duration of 4 weeks.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Medically stable type 2 diabetes mellitus RBS greater than 200 mg per dl
2. Sharp Pain like tingling or burning sensation in the feet or legs especially at night
3. Pain intensity is more than 3 on VAS and more than 4 on DN4.
4. Participants diagnosed with peripheral polyneuropathy by the physician
5. Participants willing to sign the informed consent. 
 
ExclusionCriteria 
Details  1. Severe musculoskeletal disorders that impair their participation in exercise.
2. Complete loss of sensation in the feet, especially in the TENS group.
3. patients with frequent severe hypoglycemia (less than 54 mg per dL)
4. Any other neurological disease other than PDN
5. Ulcers, amputation, vascular insufficiency.
6. Presence of severe cardiovascular and respiratory diseases
7. Participants with cognitive disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) VAS score
2) The DN4 (Douleur Neuropathique 4) scale
3) PSQI (Pittsburgh Sleep Quality Index)
4) SLS (single leg stance) test
 
The outcome measures will be assessed at two timepoints: initially at baseline before the start of the intervention and then re-evaluated after four weeks of intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL  
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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)   16/09/2025 
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="1"
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  

The study titled Comparing the Effects of Foot Exercise vs Electrical Stimulation on Pain, Quality of Sleep, and Community Participation in Individuals with Diabetic Peripheral Neuropathy is a randomized controlled trial conducted by Ashmita Ashok Vernekar at SDM College of Physiotherapy, Dharwad, under the guidance of Dr. Salima Mulla Bijapuri. Diabetic Peripheral Neuropathy (DPN) is a common and debilitating complication of type 2 diabetes, leading to pain, sleep disturbances, and reduced functional mobility. The study aims to assess the effectiveness of foot exercises and transcutaneous electrical nerve stimulation (TENS) in reducing pain and improving sleep quality compared to standard diabetic care. Sixty-three participants aged 40 and above, diagnosed with painful DPN, will be randomly assigned to three groups: foot exercises, TENS therapy, and control. Each intervention will be administered three times per week for four weeks. Outcomes will be measured using standardized tools such as the Visual Analogue Scale (VAS), DN4, Pittsburgh Sleep Quality Index (PSQI), Single Leg Stance (SLS) test, and Michigan Neuropathy Screening Instrument (MNSI). The novelty of the study lies in its shorter intervention duration aimed at better adherence and its holistic approach addressing both pain and sleep—two critical yet often neglected aspects of DPN management. The findings are expected to support the use of non-pharmacological interventions like TENS and foot exercises as effective, affordable, and accessible treatment strategies for DPN, potentially improving patient quality of life and setting the foundation for future research in physiotherapy-based diabetic care.

 
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