| 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
|
|
|
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
|
|
|
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. |