| CTRI Number |
CTRI/2025/07/091722 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Can online pain education improve function and reduce fear in people with lumbar radiculopathy? |
|
Scientific Title of Study
|
Effects of pain neuroscience education through telerehabilitation on functional disability and pain catastrophizing in patients with lumbar radiculopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Garg |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Medical Road
Rohtak
HARYANA
124001
India |
| Phone |
8708573106 |
| Fax |
|
| Email |
bhawnagarg124@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Gakhar |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy
Medical Road
Rohtak
HARYANA
124001
India |
| Phone |
9896232146 |
| Fax |
|
| Email |
meghs80@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Gakhar |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy
Medical Road
Rohtak
HARYANA
124001
India |
| Phone |
9896232146 |
| Fax |
|
| Email |
meghs80@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, Medical Road, Rohtak, Haryana 124001 India |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, Medical Road, Rohtak, Haryana 124001 India |
| Type of Sponsor |
Government 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 |
| Bhawna Garg |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
Room no 42 Orthopedics OPD Chaudhary Ranbir Singh OPD and E Block College of Physiotherapy, PGIMS Rohtak
Rohtak
HARYANA |
8708573106
bhawnagarg124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee , Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M544||Lumbago with sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Week 1:
1. Pain management
8-10 repetitions to each side
Relaxation ex.
Hot water fermentation
Gentle range of motion ex.
2.Mobility-exercise
8-10 repetitions to each side
Pelvic rolling
3.Stretching- exercises 8-10 repetitions to each side
Piriformis stretch
Hamstring stretch
4.Stabilization and strengthening exercise
8-10 repetitions to each side
Isometric core ex.
Back press
Prone on elbow
Week 2:
1. Pain management
8-10 repetitions to each side
Relaxation ex.
Hot water fermentation
Isometric exercises
2. Mobility-exercise
8-10 repetitions to each side
Cat- camel ex.
3.Stretching- exercises 8-10 repetitions to each side
Piriformis stretch
Hamstring stretch
4.Stabilization and strengthening exercise
8-10 repetitions to each side
Bridging ex.
Gluteal strengthening ex.
The outcomes will be measured after week 2 and week 4. |
| Intervention |
Pain Neuroscience Education with conventional therapy |
Day 0: Taking Demographic details
Week 1 Day 1: Explanation of central sensitization along with the use of pictures, visual metaphors and neurology pain questionnaires etc. Patients are encouraged to go through the content given through telerehabilitation.
Day 2-7:
1. Pain management
8-10 repetitions to each side
Relaxation ex.
Hot water fermentation
Gentle range of motion ex.
2.Mobility-exercise
8-10 repetitions to each side
Pelvic rolling
3.Stretching- exercises 8-10 repetitions to each side
Piriformis stretch
Hamstring stretch
4.Stabilization and strengthening exercise
8-10 repetitions to each side
Isometric core ex.
Back press
Prone on elbow
Week 2 Day 1 : Explanation of central sensitization along with the use of pictures, visual metaphors and neurology pain questionnaires etc. Patients are encouraged to go through the content given through telerehabilitation. The patient is encouraged to ask questions and receive clarification for any questions. Then addressing of the psychosocial aspects of the patient’s pain during any visit.
Day 2-7:
1. Pain management
8-10 repetitions to each side
Relaxation ex.
Hot water fermentation
Isometric exercises
2. Mobility-exercise
8-10 repetitions to each side
Cat- camel ex.
3.Stretching- exercises 8-10 repetitions to each side
Piriformis stretch
Hamstring stretch
4.Stabilization and strengthening exercise
8-10 repetitions to each side
Bridging ex.
Gluteal strengthening ex.
The outcomes will be measured after week 2 and week 4. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients must have a smartphone.
Pain duration- more than 3 months.
Individual diagnosed with radiating lower back pain due to PIVD and sciatica
Pain catastrophizing scale – Moderate to High level of Pain
|
|
| ExclusionCriteria |
| Details |
Recent trauma or injury.
Severe cognitive impairment.
Recent spinal surgery and plans for upcoming surgery.
Presence of red flag signs [cancer, infection, fracture].
Pregnant females.
Use of strong opioids.
|
|
|
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 |
Pain Catastrophizing Scale
Oswestry Disability Index
Numeric Pain Rating Scale |
Week 0
Week 2
Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Tampa scale of Kinesiophobia |
Week 0
Week 2
Week 4 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/08/2025 |
| 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="0"
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
|
This randomized controlled trial aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) combined with conventional therapy compared to conventional therapy alone in patients with radiating lower back pain. After screening and informed consent, participants will be randomly assigned to two groups. The experimental group will receive PNE via telerehabilitation along with conventional physiotherapy; the control group will receive only conventional therapy.
Outcome measures will include pain intensity (NPRS), pain catastrophizing (PCS), functional disability (ODI), and fear of movement (TSK), assessed at baseline and after two treatment sessions over one week. |