| CTRI Number |
CTRI/2025/11/097486 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
16/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A trial to study the effect of virtual reality training on patients with sub-acute low back pain |
|
Scientific Title of Study
|
Effect of Virtual Reality Training on Pain, Range Of Motion and Functions in Subacute Non-specific Low back Pain Patients: A Comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Parab |
| Designation |
Post Graduate Student |
| Affiliation |
D.Y.Patil Deemed to University, School Of Physiotherapy, Nerul, Navi Mumbai |
| Address |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9969265899 |
| Fax |
|
| Email |
aishparab02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riddhi Shroff |
| Designation |
Associate Professor |
| Affiliation |
D.Y.Patil Deemed to University, School Of Physiotherapy, Nerul, Navi Mumbai |
| Address |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9769491687 |
| Fax |
|
| Email |
riddhi.shroff@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Parab |
| Designation |
Post Graduate Student |
| Affiliation |
D.Y.Patil Deemed to University, School Of Physiotherapy, Nerul, Navi Mumbai |
| Address |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9969265899 |
| Fax |
|
| Email |
aishparab02@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil Deemed to be University, School of Physiotherapy, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
D.Y.Patil Deemed to University, School of Physiotherapy, Navi Mumbai |
| Address |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706 |
| 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 |
| Dr Aishwarya Parab |
D Y Patil Hospital |
Department of Musculoskeletal Physiotherapy, opd no. 29, D Y Patil Hospital, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706
Thane
MAHARASHTRA |
9969265899
aishparab02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health Research (IECBH) of Dr D Y Patil Medical College & Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, (2) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercise protocol vs Virtual Reality Training Protocol |
The control and experimental group shall undergo a 4 week treatment protocol, were the control group shall receive an evidence based conventional exercise protocol which includes stretching, range of motion and strength training, while experimental group participant shall undergo a virtual reality based training protocol which includes exercises for forward flexion, rotation, lateral flexion and extension component. These both shall aim to improve range of motion and functional level of patients with subacute non specific low back pain and to evaluate its effect on pain. The total duration of the study is 6 months, where each participant shall undergo a 4-week protocol as per their recruitment, 3 sessions per week (alternate days). |
| Intervention |
Virtual Reality Training |
A virtual reality training- fully immersive VR for the experimental group, which shall place the user in a fully virtual environment due to headset based experience created to perform exercise to improve forward flexion, extension, lateral flexion and rotations in patient with subacute non specific low back pain. The total duration of the study is 6 months, where each participant shall undergo a 4-week protocol as per their recruitment, 3 sessions per week (alternate days). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 18 to 45 years
2.Gender: Male and Female
3.Low Back Pain more than 6 weeks
4.Availability of radiographic data (e.g. X-ray, MRI, CT scans) relevant to patient’s low back pain condition.
5.Patients must have been diagnosed with subacute low back pain (lasting from more than 6 weeks to 12 weeks) and recommended by an orthopedic specialist for further evaluation and rehabilitation.
6.Subacute, unilateral, low back, buttock or thigh pain with symptoms reproduce with end range spinal motions. Symptoms reproduced with provocation of the involved lower thoracic lumbar or sacroiliac segments.
7.Presence of 1 or more of the following:
I. Restricted thoracic range of motion and associated segmental mobility.
II. Restricted lumbar range of motion and associated segmental mobility.
III. Restricted lumbopelvic or hip range of motion and associated accessory mobility.
8.Lumbosacral pain with mid-range motions that worsen with end-range movements or positions
9.Low back and low back–related lower extremity pain reproduced with provocation of the involved lumbar segment(s)
10.Lumbar hypermobility with segmental mobility assessment may be present
11.Mobility deficits of the thorax and, or lumbopelvic or hip regions.
12.Diminished trunk or pelvic-region muscle strength and endurance.
13.Movement coordination impairments while performing self-care or home management activities.
|
|
| ExclusionCriteria |
| Details |
1.Patients with any history of surgery, infection, rheumatologic diseases.
2.Patient with any lumbar compression fractures.
3.Patients with Mid-back, low back, and back-related radiating pain or paraesthesia that are reproduced with mid-range and worsen with end range:
a) Lower limb tension testing/straight leg raising tests, and, or.
b) Slump tests
May have lower extremity sensory, strength, or reflex deficits associated with the involved nerve(s)
4.Pain related to cognitive or affective tendencies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue scale
Modified Schober’s Test |
Baseline (pre treatment) and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Back Performance Scale |
Baseline (pre treatment) and after 4 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)
|
27/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/11/2025 |
| 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 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
|
The study aims to evaluate Effect of Virtual Reality Training along with evidence based exercise on pain, range of motion and functions in sub-acute non specific low back pain patients. With a sample size of 66 participants. As its a comparative study, 66 participants shall be equally divided into two groups: control group and a experimental group consisting of 33 participants in each group. Participants shall be recruited as per the inclusion and the exclusion criteria. On recruiting the participants a consent shall be taken post which, every individual shall undergo a pre assessment which includes evaluation of pain, range of motion and functional level. Further they shall undergo a 4 week treatment session in which the control group shall receive a conventional evident based exercise protocol which includes stretching, range of motion exercises and strength training, while the experimental group shall receive a Virtual reality based training along with the conventional exercises to see its effect on pain, Range of motion and functions in sub acute nonspecific low back pain patients. Post 4 week of rehabilitation session, a post assessment shall be done to evaluate the effect of treatment provided to the participants which shall include the same evaluation as the pre assessment test, which include: pain evaluation using visual analogue scale, assessment of range of motion using modified schober’s test and assessment of function level using back performance scale as the outcome measures |