| CTRI Number |
CTRI/2022/01/039608 [Registered on: 20/01/2022] Trial Registered Prospectively |
| Last Modified On: |
10/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pain Education and Physiotherapy Exercises on Pain, Disability and Fear of Movement in Patients with Low Back Pain : A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Pain Education and Conventional Physiotherapy exercises on Pain, Disability and Kinesiophobia in Patients with Chronic Non-Specific Low Back Pain : 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 |
Deeba Shaikh |
| Designation |
junior resident |
| Affiliation |
MGM INSTITUTE OF PHYSIOTHERAPY |
| Address |
OPD NO 1 ,MUSCULOSKELETAL DEPARTMENT, MGM REHABILITATION AND FITNESS CENTRE , AURANGABAD
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8149497832 |
| Fax |
|
| Email |
deeba.zilch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kapil garg |
| Designation |
Associate professor |
| Affiliation |
MGM INSTITUTE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF MUSCULOSKELETAL SCIENCES, MGM INSTITUTE OF PHYSIOTHERAPY
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9027612715 |
| Fax |
|
| Email |
gargkapil9855@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deeba Shaikh |
| Designation |
junior resident |
| Affiliation |
MGM INSTITUTE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF MUSCULOSKELETAL SCIENCES, MGM INSTITUTE OF PHYSIOTHERAPY
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8149497832 |
| Fax |
|
| Email |
deeba.zilch@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM INSTITUTE OF PHYSIOTHERAPY |
|
|
Primary Sponsor
|
| Name |
MGM Institute of PHYSIOTHERAPY |
| Address |
N6 CIDCO AURANGABAD |
| 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 |
| DEEBA SHAIKH |
MGM REHABILITATION AND FITNESS CENTRE |
OPD NO 1 ,MUSCULOSKELETAL DEPARTMENT, MGM REHABILITATION AND FITNESS CENTRE,C building ,MGM CAMPUS,N6,AURANGABAD 431001
Aurangabad
MAHARASHTRA |
8149497832
deeba.zilch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGMIOPInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
core stability exercises and pain neurosciences education 45 to 50 minutes,3 sessions per week FOR 4 WEEKS. |
This will be a 45 to 50 minutes session and will be given for 3 sessions per week. The first week patient will be treated in the Opd and the rest three weeks, home protocol will be taken via video conference.
1.Heat i.e hot pack will be given for 10 minutes per day and 3 sessions per week.
2.stretching
3.core stability exercise
|
| Comparator Agent |
Pain neurosciences education – 20 to 30 minutes TWICE IN ONE MONTH |
Pain neurosciences education – this will be 20 to 30 minutes session given on
the 1st and 13th day of intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Low back pain of non-specific origin for 3 months or more.
2. VAS score ranges from 2 to 7.
3. PCS score from 18-30(25-75% affection)
4. Willingness to participate. |
|
| ExclusionCriteria |
| Details |
1.Patients on pain medication
2.Presence of congenital or acquired deformities of the spine and lower limb.
3.Recent surgeries, fracture or injuries to the spine in the past 1 year.
4.Neurological deficits
5.Spondylolisthesis , spondylosis , spondylitis , stenosis , degenerative
disease, sciatica.
6.Potts spine
7.Systemic illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain Catastrophization
2.Disability
3.Kinesiophobia |
At Baseline and at 4 weeks i.e at the end of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Pain |
At Baseline and at 4 weeks i.e at the end of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2022 |
| Date of Study Completion (India) |
13/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Background: The prevalence of low back pain in todays world is quite high among young adults due to prolonged sedentary sitting work and abnormal posturing. There are many pharmaceutical and therapeutic management present for managing the pain but very few literature is present on improving the psychosocial factors that are affected due to this pain suffering. Thus with this background , this study will be helpful in finding the effect of psychosocial counselling on pain perception and quality of life in general. AIM - To determine the effect of pain neuro physiological education along with therapeutic exercises on pain, disability and kinesiophobia in patients with non specific low back pain.Methodology : Interventional study will be conducted with 60 participants randomly allocated to experimental group (n=30) and control group (n=30). Experimental group will receive 4 weeks of exercise session(1 week in opd and rest home program) and 2 pain neurosciences education sessions one at the initiation of protocol and one on the 12th day. Control group will receive 4 weeks of exercise program with one week in opd and rest 3 at home. |