| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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.
|