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CTRI Number  CTRI/2024/07/069974 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 29/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of Nerve Flossing on Nerve Conduction Velocity and Pain in patients with Diabetic Neuropathy 
Scientific Title of Study   Effect of Nerve Flossing on Nerve Conduction Velocity and Pain in patients with Diabetic Neuropathy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushil Kumar Mahanta 
Designation  PG student 
Affiliation  Dolphin PG Institute of Biomedical and Natural Sciences 
Address  Department of Physiotherapy, Dolphin PG institute of biomedical and natural sciences, dehradun
Department of Physiotherapy, Dolphin PG institute of biomedical and natural sciences, dehradun
Dehradun
UTTARANCHAL
248007
India 
Phone  9938633270  
Fax    
Email  sushilkumarmahanta324@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deptee Warikoo 
Designation  HOD 
Affiliation  Dolphin PG Institute of Biomedical and Natural Sciences 
Address  Department of Physiotherapy, Dolphin PG institute of biomedical and natural sciences, dehradun
Department of Physiotherapy, Dolphin PG institute of biomedical and natural sciences, dehradun
Dehradun
UTTARANCHAL
248007
India 
Phone  9897741500  
Fax    
Email  deptee.pt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sushil Kumar Mahanta 
Designation  PG student 
Affiliation  Dolphin PG Institute of Biomedical and Natural Sciences 
Address  Department of Physiotherapy, Dolphin PG institute of biomedical and natural sciences, dehradun
Department of Physiotherapy, Dolphin PG institute of biomedical and natural sciences, dehradun
Dehradun
UTTARANCHAL
248007
India 
Phone  09938633270  
Fax    
Email  sushilkumarmahanta324@gmail.com  
 
Source of Monetary or Material Support  
Dolphin (PG) Institute of Biomedical & Natural Sciences Manduwala, Near Suddowala, Chakarata Rd, Dehradun, Uttarakhand 248007 
 
Primary Sponsor  
Name  Dolphin PG Institute of Biomedical and Natural Sciences 
Address  Manduwala, Near Suddowala, Chakarata Rd, Dehradun, Uttarakhand 248007 
Type of Sponsor  Other [NIL] 
 
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 Deptee Warikoo  Dolphin PG Institute of Biomedical and Natural Sciences  Department of Physiotherapy, Dolphin PG institute of biomedical and natural sciences, dehradun
Dehradun
UTTARANCHAL 
9897741500

deptee.pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethical Committee, RAC, DIBNS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G600||Hereditary motor and sensory neuropathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NEURAL MOBILIZATION  Neural mobilization (NM) is an intervention aimed at restoring the homeostasis in and around the nervous system, by mobilization of the nervous system itself or the structures that surround the nervous system. Neural mobilization eases movement between neural structures and their surroundings (interface) through manual techniques or exercise. The total duration of the intervention was 3 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age group 40 to 70 Years
Both gender male and female

 
 
ExclusionCriteria 
Details 
Patient with a cardiac pacemaker.
Amputation
Subject having sensory issues or deficit senses.
Varicose vein.
Relevant psychiatric disorder
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
nerve conduction velocity and pain  3 and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The pain will be assessed as the Secondary outcome by using VAS scale  The course of the study is about 3 weeks 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   25/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="3" 
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 purpose of this study was to find out the effect of Nerve Flossing in reducing pain and improving Nerve Conduction Velocity in Diabetic Neuropathy populations. It was found that Nerve Flossing was effective to improvement in nerve conduction velocity and pain in Diabetic Neuropathy patients.

          The current study comprised 25 participants who had been diagnosed with diabetic peripheral neuropathy for more than ten years, including 14 males and 11 females. When comparing pre-test and post-test data, the research found significant improvements in all parameters. These findings demonstrate that Sural nerve flossing techniques improve nerve function in nerve pathways. The sensory nerve conduction investigation found a greater improvement in nerve conduction velocity.

         The reason for the greater pain relief, improvement in sensory symptoms, and improvement in spinal mobility may be related to the nerve flossing technique, which is large amplitude movements performed actively in an attempt to take the nerve throughout its available range of motion, potentially affecting the nerve both mechanically and physiologically sufficient to disperse oedema and alleviate hypoxia and its associated symptoms. Furthermore, NFT induces the lumbar nerve roots to slide proximally with neck and knee flexion and distally with neck and knee extension. It also increases the sciatic nerve’s actual excursion.14

         With a dynamic variation in pressure (by stretching at one end and relaxing at the other end by neck and knee flexion, and vice versa), evacuation of intraneural oedema can be facilitated, as well as a decrease in adhesions and symptoms by allowing the nerve to move freely with minimal increase in tension. This approach may also aid in oxygenating the nerve, so alleviating ischemia discomfort. NFT lowers pressure generated by intraneural and extraneural fibrosis, hence increasing blood circulation and axonal transport, both of which are required for a neuron’s structural and functional integrity. It’s also possible that movement helps manage pain at the central nervous system level. The gate control theory states that stimulating mechanoreceptors in the joint capsule and surrounding tissues inhibits pain in the spinal cord. It might be directly related to the immobilization decrease in neurogenic inflammation.43

          Furthermore, it is theorized that moving the nerve in pain-free variants can aid in minimizing nerve compression, tension, and friction, hence diminishing its mechanosensitivity. McCracking conducted a study on LBP with radiculopathy and suggested that neurodynamic treatment techniques have some long-term effects in treating patients with non-specific low back pain and lower extremity pain with neural tension dysfunction. Similar results were found in favor of neural mobilization.44 45

          Pirart J et al. reported an overall 12% prevalence rate of diabetic neuropathy in patients with newly diagnosed diabetes. The incidence of neuropathy increased with the duration of diabetes, and after 25 years of diabetes, over 50% of patients had DN.46 The study was a prospective investigation involving over 4400 diabetic outpatients. According to data from another study, the prevalence of neuropathy rose with age, peaking at 44.2% in patients between the ages of 70 and 79. It was found to be 5% in the group of people aged 20 to 29.

          Muscle strength can also be enhanced by increasing the flexibility of shortened nerves and tissues near the joints. In such cases, improving sciatic nerve flexibility primarily tries to promote nerve tissue compliance by reducing the nervous system’s mechanosensitivity.47 This is accomplished by static and dynamic stretching therapies that move the afflicted nerve through its entire range of motion.

          The nerve flossing technique involves moving the nerve as far proximally and distally as possible through the tissues, covering every joint and body component that the nerve passes. This approach is akin to extending a cord from one end while leaving the other slack and then reversing direction. When the sciatic nerve becomes trapped, scar tissue forms along the nerve fibre, causing it to grind against muscles and bones.48 Patients may simply practice neural mobilization exercises at home, which require no special equipment and take little time to complete as part of a daily maintenance routine.49

          When the Nerve Flossing Technique is performed dynamically, the pumping impact promotes venous return, oedema distribution, and pressure reduction inside the perineurium. It diminishes sensitivity while restoring function, lowering the threat value of an injury. This would diminish the possibility of ion channel upgradation in the dorsal root ganglia and central nervous system, as well as the potential for dorsal and brain alterations. 35

          After examining the statistical data, this study found that nerve flossing activities are a useful therapy for diabetic peripheral neuropathy. These exercises not only increase nerve conduction velocity and sensory function but also help to relieve pain.

 

 
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