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CTRI Number  CTRI/2024/10/075452 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Study on the Effect of Nerve Mobilization in Diabetic Patients. 
Scientific Title of Study   Comparative Interventional Study on the Effect of Tibial Nerve Neural Mobilization on Disability Scores in Subclinical Diabetic Lower Limb Neuropathy 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Denisha Bhuva 
Designation  Post Graduate Student 
Affiliation  School of Physiotherapy, RK University 
Address  Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham, Bhavnagar Highway, Rajkot.
Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham, Bhavnagar Highway, Rajkot.
Rajkot
GUJARAT
360020
India 
Phone  7043235502  
Fax    
Email  dbhuva852@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Chirag Solanki PT 
Designation  Assistant professor, School of Physiotherapy, RK University. 
Affiliation  School of Physiotherapy, RK University 
Address  Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham, Bhavnagar Highway, Rajkot.
Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham, Bhavnagar Highway, Rajkot.
Rajkot
GUJARAT
360020
India 
Phone  9714054600  
Fax    
Email  chirag.solanki@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Chirag Solanki PT 
Designation  Assistant professor, School of Physiotherapy, RK University. 
Affiliation  School of Physiotherapy, RK University 
Address  Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham, Bhavnagar Highway, Rajkot.
Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham, Bhavnagar Highway, Rajkot.

GUJARAT
360020
India 
Phone  9714054600  
Fax    
Email  chirag.solanki@rku.ac.in  
 
Source of Monetary or Material Support  
School of Physiortherapy, RK University kasturbadham, Bhavnagar Highway, Rajkot, Gujarat, India. 360020  
 
Primary Sponsor  
Name  School of Physiotherapy RK University 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India. 360020  
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 Denisha Bhuva  School of Physiotherapy, RK University,  Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham, Bhavnagar Highway, Rajkot, Gujarat, India. 360020
Rajkot
GUJARAT 		 7043235502

dbhuva852@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, School of Physiotherapy, RK University,  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G574||Lesion of medial popliteal nerve,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Neural sliding Techniques for Tibial Nerve  Pre-Revised neuropathy disability score (NDS) will check than Neural sliding Techniques for Tibial Nerve intervention given for 3sets of 30 repetitions (2 minute with 1 minute break in between) for 3 times/week for 4 weeks. 
Comparator Agent  Neural Tensing Techniques for Tibial Nerve  Pre-Revised neuropathy disability score (NDS) will check than Neural Tensing Techniques for Tibial Nerve intervention given for 3sets of 30 repetitions (2 minute with 1 minute break in between) for 3 times/week for 4 weeks. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Diabetes present more than 7 years
Age group 50-75 years
Male and female both patients will include
Minimum Diabetic neuropathy symptom score 1 (DNS) 
 
ExclusionCriteria 
Details  Associated with other Neurological conditions
Severe Pain or Acute Inflammation in lower limb Active Ulcers or Infections in back and lower limb
Severe Peripheral Arterial Disease in lower limb Recent Surgery or Trauma in back and lower limb 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Revised neuropathy disability score
 		 At baseline and after 4 weeks intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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 2 
Date of First Enrollment (India)   21/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/10/2024 
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 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 "Comparative Interventional Study on the Effect of Tibial Nerve Neural Mobilization on Disability Scores in Subclinical Diabetic Lower Limb Neuropathy" investigates the impact of tibial nerve mobilization in patients with diabetic neuropathy. Diabetic peripheral neuropathy (DPN) is a common complication, affecting 35% of patients with diabetes, primarily type 2. The study focuses on early-stage DPN, where sensory impairment occurs without motor dysfunction. Two groups were formed, one receiving neural sliding techniques and the other neural tensing techniques, with disability scores measured before and after intervention. Conducted over six months with 300 participants, the study aims to determine whether tibial nerve mobilization can improve nerve function and reduce disability. The randomized trial highlights the potential for non-invasive treatment to improve quality of life in diabetic patients. 
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