| CTRI Number |
CTRI/2018/08/015248 [Registered on: 09/08/2018] Trial Registered Prospectively |
| Last Modified On: |
09/03/2019 |
| 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 3 combined manual therapy techniques on low back pain |
|
Scientific Title of Study
|
EFFECT OF INTEGRATED NEUROMUSCULAR INHIBITION TECHNIQUE ON TRIGGER POINTS IN SUBJECTS WITH NON SPECIFIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarana Souza Monteiro |
| Designation |
Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLES Academy Of Higher Education And Research, Institute Of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9916033217 |
| Fax |
|
| Email |
saranasouzamonteiro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh C Metgud |
| Designation |
Associate Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLES Academy Of Higher Education And Research, Institute Of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
metgud_santosh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sarana Souza Monteiro |
| Designation |
Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLES Academy Of Higher Education And Research, Institute Of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9916033217 |
| Fax |
|
| Email |
saranasouzamonteiro@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research, Belagavi, Karnataka |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Education and Research |
| Address |
KLE Academy of Higher Education and Research Institute of Physiotherapy JNMC Campus Nehru Nagar Belagavi |
| 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 |
| Sarana Souza Monteiro |
KLEs Dr. Prabhakar Kore Charitable Hospital |
KLEs Dr. Prabhakar Kore Charitable Hospital Nehru Nagar Belegavi
Belgaum
KARNATAKA |
9916033217
saranasouzamonteiro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIPT Institutional Research and Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Non specific low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hot moist pack,therapeutic ultrasound, stretching and strengthening exercises |
Hot moist pack will be given to for the low back for 15 minutes. Therapeutic Ultrasound of 3MHz will be given on trigger points in the low back region for 6 minutes and power of 0.8-1 watt/cm2. Three sets of passive static stretching will be given to the erector spinae and quadratus lumborum with 30 seconds hold for each stretch. Strenghtening exercises will be given to the abdominals and back extensors with 10 repetitions.Total 5 treatment sessions will be performed |
| Intervention |
Integrated Neuromuscular Inhibition Technique with conventional therapy |
Hot moist pack will be given for 15 minutes to the low back region. Therapeutic Ultrasound of 3 MHz will be given on trigger pints in the low back region for 6 minutes and power of 0.8-1 watt/cm2. Additionally, integrated neuromuscular inhibition technique will be given. PAtient will be in prone position and the trigger points will be identified on erector spinae and quadratus lumborum using the STAR palpation method. A) ISCHEMIC COMPRESSION
The first technique will be the ischemic compression, here the therapist will make a pincer grasp, placing the thumb and index finger on the trigger point.
The pressure applied will be slowly increased till the resistance barrier is identified.
Pressure will be maintained for a 5 seconds followed by a release of 2-3 seconds.
This is repeated until the tenderness has gone or 90 seconds has passed whichever comes first.
B) STRAIN COUNTERSTRAIN
Here the individual is passively positioned in a position of ease with varying degrees of flexion,extension, lateral flexion and rotation such that there is reduction in the tenderness based on the VAS scale
The therapist also feels for the relaxed tissue in the ease position
The individual is maintained at this position for 90 seconds
The individual is then slowly and passively returned to the neutral position
This is repeated 3 times per session.C) MUSCLE ENERGY TECHNIQUE
The individual will be in supine position with the feet crossed
The individual will be positioned in a “banana shape†, where the individual is slightly bend away from the side which is being treated
The affected muscle will be palpated
The individual will place the arm of the side to be treated behind his/her neck
Therapist will stand on the opposite side keeping the cephalad hand below the individuals shoulder and grasp the treated side axilla
The therapists caudad hand is placed firmly but carefully on the ASIS on the side to be treated
The individual is instructed to very lightly side bend towards the treated side
This produces an isometric contraction
After 10 seconds the patient is asked to relax completely for 5 seconds and side bend towards the non treated side
The stretch is maintained for 30 seconds
This will be repeated 3 times per session
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Acute low back pain which is less than 3 months and non specific
Individuals between the age of 18-35 years.
Presence of trigger points in the low back region
Minimum score of 10% on MODQ
Decreased lumbar range of motion
Individuals willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
History of any recent spinal surgeries
History of vertebral fractures
Lumbar radiculopathy
Pregnancy
Any malignancy
Diagnosed cases of any systemic illnesses
•Infections
•Any comorbid conditions
|
|
|
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 |
| Pain Pressure Threshold and Lumbar range of motion |
On the 1st day before the intervention and on the 5th day after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Oswestry Disability Questionnaire (MODQ) |
On the 1st day before the intervention and on the 5th day after the intervention |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/08/2018 |
| Date of Study Completion (India) |
20/02/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study was conducted on the efficacy of Integrated Neuromuscular Inhibition Technique(INIT) on upper trapezius trigger points in subjects with non specific neck pain which concluded that INIT had a potential benefit in deactivating upper trapezius trigger points. Most manual therapy techniques like myofascial release,massage, stretching, work on the muscle fibre and not trigger points specifically. Currently there are various manual and non manual interventions which deactivate trigger points. Trigger points have the potential to restrict functional activities, arouse pain, limit range of motion, and hence should be treated as a part of a comprehensive regime. Although randomized clinical trials are carried out to study the effect of ischemic compression and strain counter strain in neck and chronic myofascial pain syndrome, there is lack of evidence regarding the use of these techniques in subjects with non specific low back pain. Hence additional research has to be carried out in this area. The purpose of the study is to see the effect of Integrated Neuromuscular Inhibition Technique versus conventional physiotherapy exercises on trigger points on individuals with non specific low back pain in terms of pain pressure threshold,lumbar range of motion and functional index. |