| CTRI Number |
CTRI/2025/08/092436 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Which Treatment Works Best for Long-Term Low Back Pain? Comparing Virtual Reality, Pain Neuroscience Education, and Regular Physiotherapy |
|
Scientific Title of Study
|
The Short-Term Effects of Virtual Reality Versus Pain Neuroscience Education Versus Conventional Physiotherapy on Pain, Kinesiophobia, Catastrophizing, and Disability in Patients With Chronic 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 |
Anjumanisha C Engineer |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of physiotherapy |
| Address |
OPD number 5 Orthopedic Physiotherapy Department, SDM College of Physiotherapy, SDM College of Medical Sciences and Hospital, Manjushree Nagar, Sattur, Dharwad Karnataka, India 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7892709736 |
| Fax |
|
| Email |
anjumanisha2610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjumanisha C Engineer |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of physiotherapy |
| Address |
OPD number 5 Orthopedic Physiotherapy Department, SDM College of Physiotherapy, SDM College of Medical Sciences and Hospital, Manjushree Nagar, Sattur, Dharwad Karnataka, India 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7892709736 |
| Fax |
|
| Email |
anjumanisha2610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sweta Kulkarni |
| Designation |
Professor and PG guide |
| Affiliation |
SDM College of physiotherapy |
| Address |
OPD number 5 Orthopedic Physiotherapy Department, SDM College of Physiotherapy, SDM College of Medical Sciences and Hospital, Manjushree Nagar Sattur, Dharwad, Karnataka, India 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9886276543 |
| Fax |
|
| Email |
dr.shweta07@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Medical sciences and hospital, SDM College of Physiotherapy Manjushreee Nagar, Sattur Dharwad karnataka 580009 India |
|
|
Primary Sponsor
|
| Name |
Anjumanisha C Engineer |
| Address |
OPD number 5 Orthopedic Physiotherapy Department, SDM College of Physiotherapy, SDM College of Medical Sciences and Hospital, Manjushree Nagar, Sattur, Dharwad KARNATAKA 580009 |
| 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 Anjumanisha C Engineer |
Shri Dharmasthala Manjunatheshwar hospital, Dharwad |
OPD number 5 Orthopedic Physiotherapy Department, SDM College of Physiotherapy, SDM College of Medical Sciences and Hospital, Manjushree Nagar, Sattur, Dharwad Karnataka, India 580009
Dharwad
KARNATAKA |
7892709736
anjumanisha2610@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Medical Sciences and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M990||Segmental and somatic dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Virtual Reality |
Participants in this group will receive a combination of immersive VR-based training and targeted exercise therapy. The VR component involves interactive games such as roller coaster or racing simulations, which are controlled through trunk movements while the individual is seated without back support, thereby challenging balance and promoting core muscle engagement. Each VR session lasts for 10 to 15 minutes and is intended to serve as a distraction, helping to reduce the conscious perception of pain by stimulating cortical and subcortical areas in the brain and altering pain modulation pathways. Alongside VR exposure, participants perform specific exercises such as abdominal drawing and bracing, various forms of trunk rotation, and bridging, all of which are aimed at enhancing trunk stability and functional movement. The intervention is administered twice weekly for four weeks, with each session lasting approximately 45 to 60 minutes. |
| Intervention |
Group B - Pain Neuroscience Education |
This group will receive a combination of educational sessions and structured exercise therapy. The PNE component involves teaching patients about the neurophysiological and neurobiological mechanisms underlying pain to reduce fear-avoidance behavior and pain catastrophizing. Patients are educated about pain as a brain-generated experience influenced by psychological and social factors, aiming to shift their beliefs away from a purely biomedical model. Interactive methods such as tactile localization, two-point discrimination training using an aesthesiometer, and graphesthesia training on the lower back are employed to enhance body awareness and sensory perception. Graded motor imagery techniques, including left-right discrimination and explicit motor imagery exercises using the Recognize™ app, are also integrated to improve cortical representation of movement and reduce fear. In addition to the educational strategies, participants engage in exercises like abdominal drawing, abdominal bracing, various trunk rotations, and bridging to improve physical function. Each session lasts 45 to 60 minutes and is conducted twice weekly for four weeks. |
| Comparator Agent |
Group C- Conventional physiotherapy |
Participants in this group will receive integrated electrotherapy with a structured, progressive exercise program aimed at improving core strength, posture, and functional mobility. Electrotherapy is administered through Interferential Therapy (IFT) with specific parameters including a pulse duration of 100 µs, base frequency of 4000 Hz, alternating frequency of 50–100 Hz, and a treatment duration of 20 minutes. The exercise protocol is delivered over four weeks, with two sessions per week, each lasting 45–60 minutes. Exercises are tailored weekly, beginning with abdominal drawing, bracing, trunk rotations, and bridging in the first week, and gradually progressing to include more challenging movements like unilateral bridging with weights, diagonal curl-ups using resistance bands, and prone hip extensions by the fourth week. Each exercise is performed with a 10-second hold and 10 repetitions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects having low back pain more than 12 weeks or 3months ( Non specific)
2) Age group of 18 to 50 years
3) TSK-17 score equal or greater than 17
4) PCS equal or greater than 30
5) VAS equal or greater than 3 |
|
| ExclusionCriteria |
| Details |
1) Suspected spinal pathology like malignancies, Unhealed vertebral fractures, ankylosing spondylitis, Inflammatory arthritis, Cauda equina syndrome, Spondylolisthesis.
2) Pregnancy.
3) Patients with vision, speech and auditory disorders.
4) Involvement of other systems or multiple systems issues.
5) Unwilling to participate voluntarily. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.VAS
2.TAMPA Scale
3.Pain Catastrophizing scale
4.Pain Pressure Threshold
5.Oswestry Disability Index |
1.VAS (baseline and 4th week)
2.TAMPA Scale (baseline and 4th week)
3.Pain Catastrophizing scale (baseline and 4th week)
4.Pain Pressure Threshold (baseline and 4th week)
5.Oswestry Disability Index (baseline and 4th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lumbar Range of Motion |
baseline and 4th week |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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 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
|
This study addresses the prevailing issue of chronic low back pain (CLBP), which is a leading cause of disability worldwide. Non-specific chronic low back pain (NSCLBP), which lacks a clearly identifiable structural or pathological origin, is particularly challenging due to its multifactorial nature involving both physical and psychological components. Psychological aspects such as kinesiophobia (fear of movement) and pain catastrophizing significantly affect recovery and quality of life. The study aims to compare the short-term effectiveness of three distinct interventions like Virtual Reality (VR), Pain Neuroscience Education (PNE), and Conventional Physiotherapy (CP) in reducing pain intensity, fear of movement, catastrophizing, and disability among NSCLBP patients. This randomized controlled trial involves 81 participants aged between 18 and 50 years who meet specific inclusion criteria. They will be randomly divided into three equal groups: Group A will receives VR-based rehabilitation along with exercises, Group B will receives PNE combined with exercise therapy, and Group C will receives conventional physiotherapy. Outcome measures include the Visual Analog Scale (VAS), Tampa Scale of Kinesiophobia (TSK-17), Pain Catastrophizing Scale (PCS), Oswestry Disability Index (ODI), Pain Pressure Threshold, and lumbar range of motion assessments. Interventions are administered over four weeks, with pre- and post-assessments to evaluate effectiveness at baseline and 4th week. Virtual Reality is used to provide immersive, task-oriented activities that distract attention from pain and promote movement. PNE focuses on educating patients about the neurophysiological basis of pain to reduce fear and maladaptive beliefs. The conventional physiotherapy group follows standard treatments involving strengthening, stretching, and electrotherapy. The expected outcome is that both VR and PNE may yield superior psychological and functional benefits compared to CP. The study also explores the feasibility and acceptability of VR-based therapy in Indian clinical settings. By comparing these three approaches, this research aims to identify the most effective method for managing NSCLBP and contribute to evidence-based clinical decision-making. |