| CTRI Number |
CTRI/2022/10/046116 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of lower limb Neurodynamic exercises on pain,
flexibility, balance, and quality of life in diabetic neuropathy |
|
Scientific Title of Study
|
Effect of lower limb Neurodynamic exercises on pain,
flexibility, balance, and quality of life in diabetic neuropathy–
A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Minal Karani |
| Designation |
Post graduate physiotherapy student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr
prabhakar kore hospital,
Belgaum
KARNATAKA
590010
India Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr
prabhakar kore hospital,
Belgaum
KARNATAKA
590010
India Belgaum KARNATAKA 400080 India |
| Phone |
09082926556 |
| Fax |
|
| Email |
karaniminal99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anil Muragod |
| Designation |
HOD AND PROFESSOR OF GERIATRIC DEPARTMENT |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr
prabhakar kore hospital,
Belgaum
KARNATAKA
590010
India Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr
prabhakar kore hospital,
Belgaum
KARNATAKA
590010
India Belgaum KARNATAKA 400080 India |
| Phone |
|
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Minal Karani |
| Designation |
Post graduate physiotherapy student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr
prabhakar kore hospital
Belgaum
KARNATAKA
590010
India Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr
prabhakar kore hospital
Belgaum
KARNATAKA
590010
India Belgaum KARNATAKA 400080 India |
| Phone |
09082926556 |
| Fax |
|
| Email |
karaniminal99@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore hospital and MRC, Belagavi
|
|
|
Primary Sponsor
|
| Name |
Minal Karani |
| Address |
Shivbasava nagar Belagavi 59001 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| Minal Karani |
KLE Dr. Prabhakar Kore hospital |
Sagar floor, advanced
physiotherapy center,
room no. 39, KLE Dr.
Prabhakar Kore
hospital and MRC
Belgaum
KARNATAKA Belgaum KARNATAKA |
09082926556
karaniminal99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee of KAHER Institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Total duration 60 mins
4 times a week for 3 weeks.
|
| Intervention |
Neurodynamics along with conventional therapy |
Each movement – 60 sec
Interval of 60 sec from 1 movement to another.
Total 5 movements.
conventional therapy for 60 mins.
Total duration – 80 mins.
4 times a week for 3 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female of age 50 – 70yrs diagnosed with type-II DM for atleast five
years duration who are willing to participate.
> 12 score on LANSS scale indicating neuropathic pain.
HbA1c < 7
Participant able to understand and cooperate.
|
|
| ExclusionCriteria |
| Details |
Musculoskeletal disorders such as fracture, dislocation, rheumatoid arthritis, knee
joint flexion contracture, etc.
Neurological conditions like PNI, SCI, stroke, etc.
Foot ulcer or diagnosed retinopathy or nephropathy.
Diagnosed myopathy.
Diagnosed vestibular impairments. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
DN4 questionnaire
Straight leg raising test
Tinetti Performance Oriented Mobility Assessment (POMA)
|
Baseline, immediately after intervention, 1 week after intervention, 2 week after intervention and 3 week after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FACIT Fatigue Scale |
Baseline, immediately after intervention, 1 week after intervention, 2 week after intervention and 3 week after intervantion |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2022 |
| Date of Study Completion (India) |
20/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/03/2023 |
|
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Diabetic Neuropathy is defined by the symmetrical distal degeneration of peripheral nerves. Patients typically feels pain caused by an insult to the neural tissue, which leads to neurovascular insufficiency and the collection of toxins, that further causes neuronal damage. Patients may also experience muscle weakness due to motor nerve degeneration and balance impairment. Decrease in joint position sense and delayed reaction time to sudden change in center of mass leads to postural instability. This further increased risk of falls and affect activities of daily living. Thereby, affecting the quality of life. So, aim of this study was to determine the effect of lower limb neurodynamic exercises on pain, flexibility, balance, and quality of life in diabetic neuropathy. Study was approved from Institutional Ethical Committee and registered in CTRI/2022/10/046116. 30 participants of both genders within age group of 50 to 70 years with diabetes for > or = 5 years and LANSS score >12 were included and randomly allocated into 2 groups. Group A was treated by conventional therapy which lasted for 60 minutes. Group B was treated by bilateral sciatic Neurodynamics lasting for 12 minutes along with conventional therapy. Intervention was given for four times a week for 3 weeks. Pre and post (immediately after therapy, after 1st week, after 2nd week, after 3rd week of therapy) readings of DN4 questionnaire, SLR, POMA, FACIT Fatigue Scale were taken. Data collected was entered in excel spreadsheet and analyzed by SPSS software version 28.1. In within group analysis done by paired t test Group A showed pain reduction and balance improvement post 2nd week of intervention, improvement in hamstring flexibility and improvement in quality-of-life post 1st session, post 1st week of intervention respectively. Group B within group analysis suggested pain reduction and improvement in hamstring flexibility post 1st session of intervention whereas improvement in balance and quality-of-life post was seen post 1st week of intervention. Between group analysis done by independent sample t test resulted in more improvement in Group B than Group A for pain reduction, balance, and quality-of-life improvement. Hence, study concluded that both groups were effective in improving pain, flexibility, balance and quality of life in patients with Diabetic Neuropathy, but Neurodynamics group showed more improvements in DN4, POMA, FAICT Fatigue scale rather than the conventional physiotherapy group. |