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Virtual Reality Based Physical Therapy for Patients With Lower Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Virtual reality Exercises
Routine Physiotherapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring low back pain, chronic low back pain, virtual reality

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

virtual reality

Routine Physiotherapy (treatment as usual)

Arm Description

virtual reality exercises will be administered along with routine physiotherapy

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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)
Range of motion
Inclinometer (minimum range of motion zero and maximum 50).
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)
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)

Full Information

First Posted
April 18, 2023
Last Updated
August 6, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05859321
Brief Title
Virtual Reality Based Physical Therapy for Patients With Lower Back Pain
Official Title
Effects of Virtual Reality on Pain, Functional Disability and Fear Avoidance Belief in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
low back pain, chronic low back pain, virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
virtual reality
Arm Type
Experimental
Arm Description
virtual reality exercises will be administered along with routine physiotherapy
Arm Title
Routine Physiotherapy (treatment as usual)
Arm Type
Active Comparator
Arm Description
transcutaneous electrical nerve stimulation,Heat Therapy, Stretching and strengthening exercises with Cycling will be administered
Intervention Type
Other
Intervention Name(s)
Virtual reality Exercises
Intervention Description
Virtual reality exercises along with transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises
Intervention Type
Other
Intervention Name(s)
Routine Physiotherapy
Other Intervention Name(s)
treatment as usual
Intervention Description
transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
at baseline
Title
Functional disability
Description
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.
Time Frame
at baseline
Title
Pain Intensity
Description
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.
Time Frame
at 4th week
Title
Pain intensity
Description
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.
Time Frame
at 8th week
Title
Functional Disability
Description
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.
Time Frame
4th week
Title
Functional Disability
Description
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.
Time Frame
8th week
Secondary Outcome Measure Information:
Title
Fear avoidance belief
Description
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)
Time Frame
at baseline
Title
Range of motion
Description
Inclinometer (minimum range of motion zero and maximum 50).
Time Frame
Change in range of motion score will be measured at baseline, at 8th week
Title
Fear avoidance belief
Description
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)
Time Frame
4th week
Title
Fear avoidance belief
Description
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)
Time Frame
8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Umair Ahmed, PhD
Phone
00924235467358
Ext
5966
Email
umair.ahmed@uipt.uol.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Haider Ullah, MS
Phone
00924235467358
Ext
6115
Email
haiderullah@live.com
Facility Information:
Facility Name
University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Waqar, MPhil Physiotherapy
Phone
03214668377
Email
waqarafzalpt@gmail.com
First Name & Middle Initial & Last Name & Degree
Asim Arif, MS Physiotherapy
Phone
03216597727
Email
asim.pt@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Virtual Reality Based Physical Therapy for Patients With Lower Back Pain

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