Virtual Reality Based Physical Therapy for Patients With Lower Back Pain

Sponsor

University of Lahore (Other)

Overall Status

Recruiting

CT.gov ID

NCT05859321

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

41.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to compare chronic low back patients. The main question[s] it aims to answer are:

pain and disability
fear avoidance belief Participants will perform virtual reality exercises
virtual reality based exercises
Routine Physical Therapy To Compare routine physical therapy treatment in addition to virtual reality to see effects on pain, functional disability and fear avoidance belief

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain	Other: Virtual reality Exercises Other: Routine Physiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Virtual Reality on Pain, Functional Disability and Fear Avoidance Belief in Patients With Chronic Low Back Pain

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: virtual reality virtual reality exercises will be administered along with routine physiotherapy	Other: Virtual reality Exercises Virtual reality exercises along with transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises
Active Comparator: Routine Physiotherapy (treatment as usual) transcutaneous electrical nerve stimulation,Heat Therapy, Stretching and strengthening exercises with Cycling will be administered	Other: Routine Physiotherapy transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises Other Names: treatment as usual

Arm

Intervention/Treatment

Experimental: virtual reality

virtual reality exercises will be administered along with routine physiotherapy

Other: Virtual reality Exercises

Virtual reality exercises along with transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises

Active Comparator: Routine Physiotherapy (treatment as usual)

transcutaneous electrical nerve stimulation,Heat Therapy, Stretching and strengthening exercises with Cycling will be administered

Other: Routine Physiotherapy

transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises

Other Names:

treatment as usual

Outcome Measures

Primary Outcome Measures

Pain Intensity [at baseline]
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain
Functional disability [at baseline]
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.
Pain Intensity [at 4th week]
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain
Pain intensity [at 8th week]
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain
Functional Disability [4th week]
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.
Functional Disability [8th week]
Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.

Secondary Outcome Measures

Fear avoidance belief [at baseline]
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Range of motion [Change in range of motion score will be measured at baseline, at 8th week]
Inclinometer
Fear avoidance belief [4th week]
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Fear avoidance belief [8th week]
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Low back pain that persists for more than 12 weeks
Non-radiating low back pain
Mechanical low back pain
Both Gender

Exclusion Criteria:

trauma or fracture of the spine
any cardiac disease
any systematic disease
history of any neurological diseases such as Parkinson's disease, stroke and epilepsy
patient on corticosteroid or anticoagulants
history of any Drug abuse
any Congenital deformity
Virtual reality games phobia
Pregnant female

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Lahore	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

University of Lahore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Waqar Afzal, Assistant Professor, University of Lahore

ClinicalTrials.gov Identifier:

NCT05859321

Other Study ID Numbers:

IRB-UOL-FAHS/696-IV/2020

First Posted:

May 15, 2023

Last Update Posted:

May 15, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Waqar Afzal, Assistant Professor, University of Lahore

low back pain

chronic low back pain

virtual reality

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of May 15, 2023