| CTRI Number |
CTRI/2024/08/072848 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect on quality of life in
non specific low back ache patients on performing intervention Integrated Neuromuscular Inhibition Technique and Strain counter Strain Technique |
|
Scientific Title of Study
|
Effect of Integrated Neuromuscular Inhibition Technique and Strain counter Strain Technique on Quality of Life in Patients with Non-Specific 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 |
ANTIMA JAIN |
| Designation |
MPT musculoskeletal student |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal physiotherapy department,
Chandiwala Estate Maa Anandmai Marg New Delhi Delhi 110019
South
DELHI
110019
India |
| Phone |
|
| Fax |
|
| Email |
jainantima004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CHANCHAL JAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal physiotherapy department
Chandiwala Estate Maa Anandmai Marg New Delhi Delhi 110019
South
DELHI
110019
India |
| Phone |
9810648719 |
| Fax |
|
| Email |
chanchal@bcip.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHANCHAL JAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal physiotherapy department
Chandiwala Estate Maa Anandmai Marg New Delhi Delhi 110019
South
DELHI
110019
India |
| Phone |
9810648719 |
| Fax |
|
| Email |
chanchal@bcip.ac.in |
|
|
Source of Monetary or Material Support
|
| Banarsidas Chandiwala Institution of PHYSIOTHERAPY,Chandiwala Estate, Metro Station, Ma Anandmayee Marg, near govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi 110019,India |
|
|
Primary Sponsor
|
| Name |
ANTIMA JAIN |
| Address |
Chandiwala Estate, Maa Anandmai Marg, New Delhi, Delhi 110019 |
| 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 Ankit Sharma |
Sri Balaji Action Medical Institute |
Spine and rehabilitation department,Fc34 Baba Ram Dev Marg Janta Flats Paschim Vihar Delhi 110063
West
DELHI |
8800564684
dr.ankit4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BCIC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
integrated neuromuscular inhibition technique
|
intervention will be given for 2 weeks which will be 2 sessions per week |
| Comparator Agent |
Strain counter strain technique |
intervention will be given for 2 weeks which will be 2 sessions per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Young individuals of age 18-35 years
Both male and female
Participants with NSLBP since 3 months,
Reduced ROM and minimum of 10 percent score in modified Oswestry scale
Trigger points on paraspinal muscles
• BMI 20-30 kg/m2
|
|
| ExclusionCriteria |
| Details |
Acute Spinal injuries
Vertebral fractures, lumber radiculopathy, pregnancy
Acute Systemic illness of infections
Any other comorbid conditions related to spine such as prolapsed intervertebral disc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Oswestry scale for quality of life |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Modified Schober’s test for range of motion
Numeric rating scale for pain |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/09/2024 |
| 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="6"
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
|
• Integrated neuromuscular inhibition technique: it is comprising of three technique including ischemic compression, strain counter-strain and muscle energy technique. • Strain counter-strain technique is a passive technique used to decrease musculoskeletal pain by positing the muscle into maximum relaxing position thereby reducing trigger point sensitivity. sample size:66 site of study : New Delhi
|