| CTRI Number |
CTRI/2024/06/068475 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of Plantar Vibration Therapy on Plantar Nerve Sensation and Nerve Transmission Velocity in Diabetic Neuropathy Patients |
|
Scientific Title of Study
|
Effect of Plantar Vibration Therapy On Sensation and Nerve Conduction Velocity Of Plantar Nerve In Diabetic 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 |
Kratika Dubey |
| Designation |
M.P.Th |
| Affiliation |
DR. D.Y. Patil College of Physiotherapy |
| Address |
DR. D. Y. Patil College of Physiotherapy,3rd floor, Department of Neurophysiotherapy, Sant Tukaram Nagar,Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9755293627 |
| Fax |
|
| Email |
kratikadubey47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Khandare |
| Designation |
Proffesor |
| Affiliation |
DR. D.Y. Patil College of Physiotherapy |
| Address |
DR. D. Y. Patil College of Physiotherapy,3rd floor, Department of Neurophysiotherapy, Sant Tukaram Nagar,Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
8149853651 |
| Fax |
|
| Email |
shilpa.khandare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Khandare |
| Designation |
Proffesor |
| Affiliation |
DR. D.Y. Patil College of Physiotherapy |
| Address |
DR. D. Y. Patil College of Physiotherapy,3rd floor, Department of Neurophysiotherapy, Sant Tukaram Nagar,Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
8149853651 |
| Fax |
|
| Email |
shilpa.khandare@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy,third floor, Sant tukaram nagar,Pimpri.Pune.411018 |
|
|
Primary Sponsor
|
| Name |
Kratika Dubey |
| Address |
Dr. D. Y. Patil College of Physiotherapy,3rd floor, Department of Neurophysiotherapy, sant tukaram nagar,Pimpri.Pune. |
| Type of Sponsor |
Other [self] |
|
|
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 shilpa khandare |
Dr. D. Y. Patil College Of Physiotherapy |
Dr. D. Y. Patil College Of Physiotherapy,3rd floor, department of neurophysiotherapy,sant tukaram nagar,pimpri
Pune
MAHARASHTRA |
9755293627
kratikadubey47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Dr. D. Y. Patil College Of Physiotherapy,Pune, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Novel protocol consisting of vibration therapy. |
this is a three weeks protocol.patient will be given localised vibration therapy of 30 - 50 hz over the sole of the foot,for 12 mins, three sessions per week will be given. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cut off of cut-off of Plantar nerve -SNAP amplitude of 4.55 lV and 2.65 lV
Type 2 diabetes mellitus of minimum 8 years
Diagnosed DPN for more than 1 year,
Age between 35 yr and above.
More than 2.5 score in Michigan neuropathy screening instrument.
|
|
| ExclusionCriteria |
| Details |
Patient diagnosed with mental disease.
Patients having impaired vibration sensation
orthopedic, neurological disorders related to balance disturbances,skin lesions. Bone deformities in the feet.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nerve conduction velocity.
Monofilament for sensation
Tuning fork and pin for sensation.
• Michigan Neuropathy Screening Instrument
|
1) At the biginning of the study
2) at the end of the study ( after 3 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 1 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Diabetes is a very common condition affecting 101 million
population of India in 2021 (1). Chronic diabetes leads to several
complications.
Diabetic peripheral neuropathy (DPN) is one of the most common
complications of patients with Type 2 diabetes mellitus (T2DM), which affects sensation, proprioception and somatosensory information.
The symptoms of diabetic neuropathy include reduced sensation,
numbness, burning sensation, and pain, especially in the lower extremities due
to nerve damage .Tactile sensations mostly affected in this condition.Chronic neuropathy when not managed leads to further
complication like diabetic foot. Currently, diagnosis of diabetic PN is mostly clinical, further
confirmed by nerve conduction study (NCS) of peripheral sensory nerves.Plantar nerve is the major nerve supply of the
distal lower limb. vibration therapy improves reduces the pain intensity, improves
the glycemic control, skin blood flow, muscle strength, which makes it
applicable for DPN prevention or for delaying its progression.Localised plantar vibration has shown to improve proprioception and balance in diabetic
patients There are studies which indicates that nerve conduction
velocity of plantar nerve is a predictor for diabetic foot which can be caused
by chronic peripheral neuropathy. Predicting diabetic foot in pre-symtomatic stage would aid in foot
care and prevent further complications. Vibration therapy has shown effects on blood flow, strength and
flexibility. So there was a need to study if the vibration therapy affects
nerve conduction velocity of plantar nerve.
|