| CTRI Number |
CTRI/2023/11/060058 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical trial to study the Effect of Neural Mobilization With KAATSU Training On Pain, Hip Range Of Motion, Quality Of Life in Subjects With Sciatica |
|
Scientific Title of Study
|
EFFECT OF NEURAL MOBILIZATION WITH KAATSU TRAINING ON PAIN, HIP RANGE OF MOTION, QUALITY OF LIFE IN SUBJECTS WITH SCIATICA-A RANDOMISED CONTROLLED 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 |
AMANULLA TASHILDAR |
| Designation |
PG student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR OPD NO 39 BELGAUM |
| Address |
KAHER Institute of physiotherapy OPD No 39 Orthopaedic physiotherapy Nehru Nagar Belgaum
KAHER Institute of physiotherapy OPD No 39 Orthopaedic physiotherapy Nehru Nagar Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
07406220320 |
| Fax |
|
| Email |
amantashildar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Kage |
| Designation |
Proffessor |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
KLES DR.Prabhakar kores Hospital OPD NO 39 Department of Orthopeadic physiotherapy Nehru Nagar Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Kage |
| Designation |
Proffessor |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
KLES DR.Prabhakar kores Hospital OPD NO 39 Department of Orthopeadic physiotherapy Nehru Nagar Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
|
Source of Monetary or Material Support
|
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
KLES DR.Prabhakar kores Hospital OPD NO 39 Department of Orthopeadic physiotherapy Nehru Nagar Belgaum. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Amanulla Tashildar |
KLES DR.Prabhakar Kores hospital and medical research center |
KLES DR.Prabhakar kores Hospital OPD NO 39 Department of Orthopeadic physiotherapy Nehru Nagar Belgaum.
Belgaum
KARNATAKA |
07406220320
amantashildar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neural Mobilization And conventional treatment |
Neural Mobilization And conventional treatment will be given thrice a week for 2 weeks of intervention |
| Comparator Agent |
Neural Mobilization With KAATSU Training And conventional treatment |
Neural Mobilization With KAATSU Training And conventional treatment will be given thrice a week for 2 weeks of intervention |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects clinically Diagnosed with Sciatica.
All genders with 30 to 50 years of age.
Pain at SLR between 30 – 70 degrees or Lasegue’s sign any one positive.
Subjects with VAS score more >3.
Subjects willing to participate.
Duration of symptoms from four to eight weeks.
|
|
| ExclusionCriteria |
| Details |
Subjects with Lower limb and spinal fractures
Having Uncontrolled Diabetes mellitus.
Who underwent Current Pregnancy.
Subjects with Malignancy.
Subjects having Infection.
Diagnosed with Osteoporosis.
Structural Deformity on spine
People who cannot comprehend or follow command |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Sciatica using VAS(Visual analogue scale) |
Assessment of Sciatica using VAS(Visual analogue scale)
Pre at the baseline and post after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional disability using Modified Oswestry disability questionnaire
Core Strength using Pressure biofeedback |
Functional disability using Modified Oswestry disability questionnaire
Pre at baseline & post after 2 weeks
Core Strength using Pressure biofeedback
Pre at baseline & post after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2023 |
| Date of Study Completion (India) |
03/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim:To determine the effect of neural mobilization with kaatsu training on pain, hip range of motion, quality of life in subjects with sciatica . Inclusion criteria: Subjects clinically Diagnosed with Sciatica. All genders with 30 to 50 years of age. Pain at SLR between 30 – 70 degrees or Lasegue’s sign –any one positive. Subjects with VAS score more >3 Subjects willing to participate. Duration of symptoms from four to eight weeks. Exclusion criteria: Subjects with Lower limb and spinal fractures Having Uncontrolled Diabetes mellitus. Who underwent Current Pregnancy. Subjects with Malignancy. Subjects having Infection. Diagnosed with Osteoporosis. Structural Deformity on spine
|