Virtual Reality Based Physical Therapy for Patients With Lower Back Pain

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Virtual reality Exercises; Other: Routine Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Umair Ahmed, PhD; Phone Number: 5966 00924235467358; Email: umair.ahmed@uipt.uol.edu.pk
• Study Contact Backup: Name: Haider Ullah, MS; Phone Number: 6115 00924235467358; Email: haiderullah@live.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Recruiting
      • University of Lahore
      • Contact: Muhammad Waqar, MPhil Physiotherapy; Phone Number: 03214668377; Email: waqarafzalpt@gmail.com
      • Contact: Asim Arif, MS Physiotherapy; Phone Number: 03216597727; Email: asim.pt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.	at baseline
Functional disability	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.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.	at baseline
Pain Intensity	The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.	at 4th week
Pain intensity	The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.	at 8th week
Functional Disability	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.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.	4th week
Functional Disability	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.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.	8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear avoidance belief	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)	at baseline
Fear avoidance belief	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)	4th week
Fear avoidance belief	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)	8th week
Range of motion	Inclinometer (minimum range of motion zero and maximum 50).	Change in range of motion score will be measured at baseline, at 8th week

Collaborators and Investigators

• Sponsor: University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Estimated): August 5, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 13, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; chronic low back pain; virtual reality
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB-UOL-FAHS/696-IV/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No