| CTRI Number |
CTRI/2024/03/063403 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| 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
|
Neuro kinetic therapy to improve abdominal muscle strength for the treatment of low back pain |
|
Scientific Title of Study
|
Effectiveness of neuro kinetic therapy on core muscles dysfunction on among subjec†s with mechanical low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Theepan Kumar |
| Designation |
Research Scholar |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
room no c5 health science building physiotherapy department saveetha college of physiotherapy saveetha nagar thandalam kancheepuram district
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9884064530 |
| Fax |
|
| Email |
theepank1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumaresan A |
| Designation |
Professor |
| Affiliation |
Saveetha College of Physiotherapy Saveetha Institute of Medical and Technical Sciences |
| Address |
room no c5 health science building physiotherapy department saveetha college of physiotherapy saveetha nagar thandalam kancheepuram district
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7299934070 |
| Fax |
|
| Email |
kresh49@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Theepan Kumar |
| Designation |
Research Scholar |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
room no c5 health science building physiotherapy department saveetha college of physiotherapy saveetha nagar thandalam kancheepuram district
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9884064530 |
| Fax |
|
| Email |
theepank1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
|
|
Primary Sponsor
|
| Name |
Saveetha College of Physiotherapy Saveetha Institute of Medical and TechnicalSciences |
| Address |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and TechnicalSciences,Saveetha Nagar,Thandalam,Chennai-602105 |
| 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 |
| DrKumaresan |
Saveetha College ofPhysiotherapy SaveethaInstitute of Medical andTechnical Sciences |
room no c5 health science building physiotherapy department saveetha college of physiotherapy saveetha nagar thandalam kancheepuram district
Kancheepuram
TAMIL NADU |
7299934070
kresh49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, (2) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lumbar stabilization program |
2weeks,6daysperweek |
| Intervention |
Neuro kinetic therapy and lumbar stabilization program |
2weeks,6daysperweek |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Low back pain with or without leg pain
Acute stage within 6 weeks |
|
| ExclusionCriteria |
| Details |
Ligament laxity in lumbar region
Lumbar spinal stenosis
Lumbar discs prolapse
Subjects with TB spine, Tumors, Severe Osteoporosis, Pregnancy and cardio vascular diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric pain rating scale
Modified schobers test
EMG
Diagnostic ultrasound
Back pain functional scale |
pre test on Zero day before intervention and post test on day 15 immediately after the intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
EMG
Diagnostic ultrasound
|
pre test on Zero day before intervention and post test on day 15 immediately after the intervention
|
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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)
|
01/04/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
The subjects from the physiotherapy OPD and IP will be involved in the study according to inclusion and exclusion criteria. Subjects will be explained about safety and simplicity of Research procedure, purpose and duration. The informed consent and information sheet will be obtained. All the samples assessed by surface EMG, Diagnostic Ultrasound, NPRS scale, ROM, QOL scale. The values will be tabulated and statistically analyzed. Further by the closed envelope method the volunteers will be allocated into two groups, NKT and CONVENTIONAL group. The participants in NKT group will be given NKT and lumbar stabilization program. The participants in the CONVENTIONAL group will be treated with only Lumbar stabilization program for 2weeks,6 days per week. |