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CTRI Number  CTRI/2025/07/090996 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the effectiveness of Intraneural Facilitation and Buerger-Allen exercises on Pain and Quality of Life Among Patients with Diabetic Peripheral Neuropathy 
Scientific Title of Study   Effectiveness of Intraneural Facilitation and Buerger-Allen exercises on Pain and Quality of Life Among Patients with Diabetic Peripheral 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  Hebsiba P 
Designation  PhD Scholar 
Affiliation  NITTE Usha Institute of Nursing Sciences 
Address  NITTE USHA Institute of Nursing Sciences NITTE Deemed to be University Deralakatte Mangalore
Professor Sree Gokulam Nursing College Sree Gokulam Medical College Campus Venjaramoodu Trivandrum PIN: 695607
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9496304570  
Fax    
Email  hebsiba.23pnns104@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nalini M 
Designation  Professor 
Affiliation  NITTE Usha Institute of Nursing Sciences 
Address  Department of Psychiatric Nursing Nitte Usha Institute of Nursing Sciences Nitte Deemed to be University Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8095679510  
Fax    
Email  nalini@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Lija R Nath 
Designation  Professor 
Affiliation  Sree Gokulam Nursing College 
Address  Vice Principal Sree Gokulam Nursing College Venjaramoodu Trivandrum

Thiruvananthapuram
KERALA
695607
India 
Phone  9947367686  
Fax    
Email  lija475nc@sgnc.edu.in  
 
Source of Monetary or Material Support  
NITTE Usha Institute of Nursing Sciences NITTE Deemed to be University Karnataka, India PIN:575018 
 
Primary Sponsor  
Name  Hebsiba P 
Address  PhD Scholar NITTE Usha Institute of Nursing Sciences Deralakatte Mangalore, India PIN:575018 
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 
Hebsiba P  Sree Gokulam Medical College and Research Foundation  OPDs of Endocrinology and Department of Physiotherapy, Venjaramoodu Thiruvananthapuram PIN:695607
Thiruvananthapuram
KERALA 		 9496304570

hebsiba.23pnns104@student.nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE - SREE GOKULAM MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Buerger-Allen exercises  Buerger-Allen exercise: Buerger-Allen exercises are a sequence of positional and movement exercises designed to improve circulation in the lower extremities by promoting vascular and muscular function. In this study, Buerger-Allen exercises consist of three distinct phases performed under supervision: (1) Elevation Phase, where the legs are elevated above heart level (45 to 60 degree) for 2-3 minutes to encourage venous drainage; (2) Dependency Phase, where the legs are lowered below heart level and performs dorsiflexion and plantar flexion and moves legs in and out for 5-10 minutes to increase arterial blood flow; and (3) Horizontal Rest Phase, where the legs are placed in a neutral horizontal position for 2-5 minutes to stabilize circulation Therapy will be provided 3 times a week for 5 weeks and each session is for 50-60 mts. 
Intervention  Intraneural Facilitation   Intraneural Facilitation: Intraneural facilitation refers to manual stretch and pressure hold of specific nerve areas of lower extremity to bring pressurized blood flow to damaged nerves. In this study, INF is structured intervention plan which comprised of 50-60 minutes administered by the researcher after training who performs specific, controlled positioning and gentle stretching of the affected limb to target and increase microvascular blood flow within nerve tissues. The procedure involves holding the limb in particular positions to decompress the blood vessels supplying the nerve, thereby facilitating increased oxygenation and nutrient delivery to nerve cells. Therapy will be provided 3 times a week for 5 weeks and each session is for 50-60 mts. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Type 2 Diabetes mellitus patients with below-ankle diabetic peripheral neuropathy symptoms
Patients with moderate to severe diabetic peripheral neuropathy 
 
ExclusionCriteria 
Details  Patients with other chronic illness like cancer, renal failure, CLD, COPD
Patients with diabetic foot
Patients with active inflammation
Patients with other neuropathies not associated with DM 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain and quality of life  post-test at the end of 3rd week and 5th week. That is, primary outcome will be assessed at baseline (pretest), end of 3rd week (posttest 1) and end of 5th week (posttest 2). 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
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)   01/08/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  hebsiba.23pnns104@student.nitte.edu.in

  6. For how long will this data be available start date provided 01-08-2027 and end date provided 01-08-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Diabetic peripheral neuropathy (DPN), a major diabetes complication, is now a leading cause of global disability. DPN causes damage to the nerves in the hands, arms, legs and feet, and it can eventually lead to ulcers, amputation and other long-term disability. "More than 50% of individuals with type 2 diabetes develop DPN symptoms". DPN complications can negatively affect the patient’s quality of life (QOL), with impaired balance, altered gait, and increased pain. Therefore, this study study is to compare the effectiveness of Intraneural Facilitation and Buerger-Allen exercise on Pain and Quality of Life Among Patients with Diabetic Peripheral Neuropathy. A True Experimental design will be used for the study. The study will be carried out in selected OPDs and Physiotherapy unit of Sree Gokulam Medical College & Research Foundation in Thiruvananthapuram district of Kerala. Concealed block sampling will be used to assign the sample in both groups. Study will be conducted by; Step 1: all patients diagnosed with Diabetic Peripheral Neuropathy (DPN) who meets inclusion criteria will be screened for intensity of diabetic peripheral neuropathy by using QOL-DN questionnaire. Those fall under moderate to severe diabetic peripheral neuropathy will be allotted in each block and further randomly assigned in both groups. Step 2: all study participants will be assessed for level of pain, quality of life and clinical parameters at pre-test. Followed by, group 1 will be given 5 weeks intraneural facilitation therapy and group 2 will be given Buerger-Allen exercise. Following therapy, assess the level of pain and quality of life at end of 3rd week of intervention (post-test 1) and level of pain, quality of life,at the end of 5th week of intervention (post-test 2). The collected data will be entered and analysed by using SPSSV.22. 

 
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