Virtual Reality Based Physical Therapy for Patients With Lower Back Pain

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859321
• Other study ID #: IRB-UOL-FAHS/696-IV/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: August 5, 2023

Study information

• Verified date: August 2023
• Source: University of Lahore
• Contact: Umair Ahmed, PhD
• Phone: 00924235467358
• Email: umair.ahmed[@]uipt.uol.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 5, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Virtual reality Exercises
Virtual reality exercises along with transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises
• Routine Physiotherapy
transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises

Locations

Country	Name	City	State
Pakistan	University of Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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