FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077935 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the effectiveness of low-level laser therapy and shortwave diathermy in treating peripheral diabetic neuropathy. 
Scientific Title of Study   Comparitive study of Low Level Laser Therapy and Short Wave Diathermy in the management of Peripheral Diabetic Neuropathy of the Lower Extremity  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Binaifer Xavier Chettiar 
Designation  Intern  
Affiliation  Dr. D. Y. Patil College of Physiotherapy  
Address  Electrotherapy Department, Dr. D.Y. Patil College of Physiotherapy, 190, Dr. D.Y. Patil College Road, Sant Tukaram Nagar, Pimpri, Pune .

Pune
MAHARASHTRA
411018
India 
Phone  9833583501  
Fax    
Email  binaiferxc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumik Basu  
Designation  Associate Professor  
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  Electrotherapy Department, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  9762165015  
Fax    
Email  soumik.physio@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Soumik Basu  
Designation  Associate Professor  
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  Electrotherapy Department, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  9762165015  
Fax    
Email  soumik.physio@dpu.edu.in  
 
Source of Monetary or Material Support  
Binaifer Xavier Chettiar, Electrotherapy Department, 3rd floor, Dr. D.Y.Patil College of Physiotherapy, 190, Dr. D.Y.Patil College Road, Sant Tukaram Nagar, Pimpri, Pune 411018 
 
Primary Sponsor  
Name  Binaifer Xavier Chettiar 
Address  B 503, Pran Bhuvan, LT Road no 2, MG Road, Goregaon West  
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 Soumik Basu  Dr. D.Y. Patil College of Physiotherapy   Electrotherapy Department, 3rd floor, 190, Dr. D.Y. Patil College Road, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune, Maharashtra
Pune
MAHARASHTRA 		 09762165015

soumik.physio@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D.Y. Patil College of Physiotherapy   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 
Intervention  A COMPARATIVE STUDY OF LOW-LEVEL LASER THERAPY VS. SHORT WAVE DIATHERMY IN THE MANAGEMENT OF PERIPHERAL DIABETIC NEUROPATHY OF THE LOWER EXTREMITY.   The study is an experimental study to see the effect of low-level laser therapy and shortwave diathermy in diabetic neuropathy. Patients who complain of pain or numbness in the lower extremity. It is a 3-day interventional study in which patients will be categorized in 2 groups. Group A consists of the patients who will be treated with low-level laser, while Group B consists of patients who will be treated with shortwave diathermy.The study concludes with a data analysis of the difference between day 1 and day 3 of the therapy in a patient treated with low-level laser therapy and shortwave diathermy. 
Comparator Agent  Low-Level Laser Therapy and Shortwave Diathermy  Group A consists of the patients who will be treated with low-level laser, while Group B consists of patients who will be treated with shortwave diathermy. On day 1 of the study, the patients with diabetic neuropathy will be given a questionnaire consisting of their demographic data, according to the intensity of pain they are experiencing by the Numerical Pain Rating Scale (NPRS) and through an outcome measure that is a treatment-induced Neuropathic Assessment Scale (TNAS). After the treatment is continued for 3 days, the same outcome measure will be reassessed, and the pain, strength-duration, and the level of neuropathy will be compared between Group A and Group B. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Type 2 diabetes mellitus and are currently on medications for the same.
2) Men and women who have complaints of neuropathies of the lower extremity occurring due to the presence of Type 2 Diabetes Mellitus  
 
ExclusionCriteria 
Details  1) Men and women under the age of 30 years
2) Men and women having Type 1 diabetes mellitus
3) Men and women having sensory impairments like hyposensitivity or hypersensitivity.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale  3 days 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment-Induced Neuropathic Assessment Scale 3.0  3 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 2 
Date of First Enrollment (India)   24/12/2024 
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="4"
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   Diabetic peripheral neuropathy is characterized by discomfort, reduced sensations, and/or numbness. There have also been reports of painful symptoms like burning, pins and needles, shooting pain, and hyper-aesthesia. Pain is often worst at night and might keep a patient from sleeping through the night.:Nonpharmacologic therapies, such as low-intensity laser therapy (LLLT), is  effective adjunctive or alternative treatments for painful Diabetic Sensory Polyneuropathy with avoidance of systemic drug adverse effects.(3) LILT has been linked to biologic benefits such as quicker trauma recovery.Shortwave diathermy (SWD) is a treatment that uses high-frequency electromagnetic radiation to treat diabetic neuropathy and other conditions. SWD can help with diabetic neuropathy by: Reducing pain: SWD can help with neuropathy pain by modulating pain impulses to the brain. Increasing circulation: SWD can increase vascular circulation and change tissue temperature .Accelerating healing: SWD can help with chronic inflammation by reducing pain, swelling, and accelerating tissue healing.  

 

The study is an experimental study to see the effect of Low Level LASER therapy and Short Wave Diathermy in Diabetic Neuropathy Patients who complaint of pain, numbness in the lower extremity. It is a 3 day interventional study in which patients will be categorized in 2 groups. Group A consist of the patients who will be treated with Low Level LASER, on the other hand Group B consists of patients who will be treated with Short Wave diathermy. On day 1 of the study, the patients with diabetic neuropathy will be given a questionnaire consisting of their demographic data, according to the intensity of pain they are experiencing by Numerical Pain Rating Scale (NPRS), Strength Duration Curve using Electrical stimulator, and through an outcome measure that is a Treatment induced Neuropathic Assessment Scale (TNAS). After the treatment is continued for 3 days, the same outcome measure will be re-assessed and the pain, strength-duration and the level of neuropathy will be compared between Group  and , Group B Group C. The study concludes by a data analysis of the difference between the day 1 and day 3 of the therapy in a patient treated with Low level Laser therapy and Short wave diathermy.

 
Close