| CTRI Number |
CTRI/2025/01/079801 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| 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
|
Physiotherapy in diabetes |
|
Scientific Title of Study
|
Effectiveness of Neurodynamic Approach in Lower Limb for
Diabetic Peripheral Neuropathy: A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ambika Kormoker |
| Designation |
Undergraduate student |
| Affiliation |
Jashore University of Science & Technology |
| Address |
Room no: 304, Department of Physiotherapy and Rehabilitation, jashore University of Science & Technology, Jashore-7408, Bangladesh
7408
Other |
| Phone |
8801779448587 |
| Fax |
|
| Email |
ambikakormokar56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ambika Kormoker |
| Designation |
Undergraduate student |
| Affiliation |
Jashore University of Science & Technology |
| Address |
Room no: 304, Department of Physiotherapy and Rehabilitation, jashore University of Science & Technology, Jashore-7408, Bangladesh
7408
Other |
| Phone |
8801779448587 |
| Fax |
|
| Email |
ambikakormokar56@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kazi Md. Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science & Technology |
| Address |
Room no: 302, Department of Physiotherapy and Rehabilitation, jashore University of Science & Technology, Jashore-7408, Bangladesh
7408
Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
kma.hossain@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, 7408 Jashore Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr. Ehsanur Rahman |
| Address |
Room: 401, Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Md Jahid Hasan |
Nurul Islam Diabetes Centre |
Room no: 201, Nurul Islam diabetes centre, Jashore, bangladesh
|
8801744129353
jahidhasantony@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy & Rehabilitation, JUST |
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 |
Neurodynamics |
neural mobilization, 10 rep. (10-15 second hold) for 4 weeks |
| Comparator Agent |
Sham neurodynamics |
Sham approach 10 rep (10-15 second hold) for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults between 40 70 years old
2. Who have been diagnosed with T2DPN & T1DPN
3. To be eligible, Individuals with unilateral or bilateral DPN
4. Individuals who will give the informed consent.
5. THE MICHIGAN DIABETIC NEUROPATHY SCORE (MDNS) more than 6.
6. symmetrical or asymmetric peripheral neuropathy accompanied by lower extremities discomfort lasting more than six months.
7. Patients who can stand or walk with aids |
|
| ExclusionCriteria |
| Details |
1. Persistent low back pain radiculopathy, and sciatalgia (for at least three days) in the previous six months.
2. Evidence of musculoskeletal dysfunctions like scoliosis, lumbar disc prolapse and lumbar spine associated radiculopathy
3. Chemical, drug, or alcohol dependency.
4. Medical diagnosis of a herniated disk in the back
5. History of lumbar surgery & trauma to the nerves of the lower
extremity.
6. Chemotherapy use within the past year.
7. Lower extremity amputations.
8. Open wounds & Infection in the lower limbs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Michigan Diabetic Neuropathy Score (MDNS) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain by VAS scale
Quality of life by Neuro QoL |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
11/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kma.hossain@just.edu.bd].
- For how long will this data be available start date provided 01-06-2025 and end date provided 01-06-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Effectiveness of Neurodynamic approach in lower limb for Diabetic Peripheral
Neuropathy
The objectives are To find out how the neurodynamic technique is beneficial for patients suffering from lower limb
diabetic peripheral neuropathy (DPN). To evaluate the impact of neurodynamic on neuropathy severity, pain, and quality of life (QoL) in
individuals with diabetic peripheral neuropathy (DPN)
Neuropathy specific quality of life questionnaire (Neuro QoL) will used patient’s assessment and follows
up after treatment intervention. To evaluate how neurodynamic mobilization and foot exercises affect patients with PDPN’s pain,
sensory complaints, and functional abilities. |