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CTRI Number  CTRI/2022/10/046116 [Registered on: 03/10/2022] Trial Registered Prospectively
Last Modified On: 06/04/2023
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   Effect of lower limb Neurodynamic exercises on pain, flexibility, balance, and quality of life in diabetic neuropathy 
Scientific Title of Study   Effect of lower limb Neurodynamic exercises on pain, flexibility, balance, and quality of life in diabetic neuropathy– A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Minal Karani 
Designation  Post graduate physiotherapy student 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital, Belgaum KARNATAKA 590010 India
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital, Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
400080
India 
Phone  09082926556  
Fax    
Email  karaniminal99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Muragod 
Designation  HOD AND PROFESSOR OF GERIATRIC DEPARTMENT 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital, Belgaum KARNATAKA 590010 India
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital, Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
400080
India 
Phone    
Fax    
Email  anilmurgod@klekipt.edu.in  
 
Details of Contact Person
Public Query
 
Name  Minal Karani 
Designation  Post graduate physiotherapy student 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital Belgaum KARNATAKA 590010 India
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
400080
India 
Phone  09082926556  
Fax    
Email  karaniminal99@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr. Prabhakar Kore hospital and MRC, Belagavi  
 
Primary Sponsor  
Name  Minal Karani 
Address  Shivbasava nagar Belagavi 59001 
Type of Sponsor  Other [self sponsored] 
 
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 
Minal Karani  KLE Dr. Prabhakar Kore hospital   Sagar floor, advanced physiotherapy center, room no. 39, KLE Dr. Prabhakar Kore hospital and MRC Belgaum KARNATAKA
Belgaum
KARNATAKA 
09082926556

karaniminal99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee of KAHER Institute of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G64||Other disorders of peripheral nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional therapy   Total duration 60 mins 4 times a week for 3 weeks.  
Intervention  Neurodynamics along with conventional therapy   Each movement – 60 sec Interval of 60 sec from 1 movement to another. Total 5 movements. conventional therapy for 60 mins. Total duration – 80 mins. 4 times a week for 3 weeks.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Both male and female of age 50 – 70yrs diagnosed with type-II DM for atleast five
years duration who are willing to participate.
> 12 score on LANSS scale indicating neuropathic pain.
HbA1c < 7
Participant able to understand and cooperate.
 
 
ExclusionCriteria 
Details  Musculoskeletal disorders such as fracture, dislocation, rheumatoid arthritis, knee
joint flexion contracture, etc.
Neurological conditions like PNI, SCI, stroke, etc.
Foot ulcer or diagnosed retinopathy or nephropathy.
Diagnosed myopathy.
Diagnosed vestibular impairments. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
DN4 questionnaire
Straight leg raising test
Tinetti Performance Oriented Mobility Assessment (POMA)
 
Baseline, immediately after intervention, 1 week after intervention, 2 week after intervention and 3 week after intervention  
 
Secondary Outcome  
Outcome  TimePoints 
FACIT Fatigue Scale  Baseline, immediately after intervention, 1 week after intervention, 2 week after intervention and 3 week after intervantion  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/10/2022 
Date of Study Completion (India) 20/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/03/2023 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Diabetic Neuropathy is defined by the symmetrical distal degeneration of peripheral nerves. Patients typically feels pain caused by an insult to the neural tissue, which leads to neurovascular insufficiency and the collection of toxins, that further causes neuronal damage. Patients may also experience muscle weakness due to motor nerve degeneration and balance impairment. Decrease in joint position sense and delayed reaction time to sudden change in center of mass leads to postural instability. This further increased risk of falls and affect activities of daily living. Thereby, affecting the quality of life. So, aim of this study was to determine the effect of lower limb neurodynamic exercises on pain, flexibility, balance, and quality of life in diabetic neuropathy. Study was approved from Institutional Ethical Committee and registered in CTRI/2022/10/046116. 30 participants of both genders within age group of 50 to 70 years with diabetes for > or = 5 years and LANSS score >12 were included and randomly allocated into 2 groups. Group A was treated by conventional therapy which lasted for 60 minutes. Group B was treated by bilateral sciatic Neurodynamics lasting for 12 minutes along with conventional therapy. Intervention was given for four times a week for 3 weeks. Pre and post (immediately after therapy, after 1st week, after 2nd week, after 3rd week of therapy) readings of DN4 questionnaire, SLR, POMA, FACIT Fatigue Scale were taken. Data collected was entered in excel spreadsheet and analyzed by SPSS software version 28.1. In within group analysis done by paired t test Group A showed pain reduction and balance improvement post 2nd week of intervention, improvement in hamstring flexibility and improvement in quality-of-life post 1st session, post 1st week   of intervention respectively.  Group B within group analysis suggested pain reduction and improvement in hamstring flexibility post 1st session of intervention whereas improvement in balance and quality-of-life post was seen post 1st week of intervention.  Between group analysis done by independent sample t test resulted in more improvement in Group B than Group A for pain reduction, balance, and quality-of-life improvement. Hence, study concluded that both groups were effective in improving pain, flexibility, balance and quality of life in patients with Diabetic Neuropathy, but Neurodynamics group showed more improvements in DN4, POMA, FAICT Fatigue scale rather than the conventional physiotherapy group.

 
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