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Effects of Virtual Reality Stabilization Training in Patients With Low Back Pain (VR)

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality (VR)
Regular Exercises
patient instructions and education
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring LBP, Psychological effects, Intervention, Virtual Reality, postural stability, balance, pain, COP

Eligibility Criteria

25 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients in Group 1 and Group 2 will be included if they: Are adults between 25 and 59 years of age. Have LBP for longer than 3 months. Are not currently undergoing medication or conservative treatment. Exclusion Criteria: Patients in these two groups will be excluded if they have: Nerve root manifestations (such as referred symptoms of radiating pain below the knee or paresthesia during the straight leg raise test), Systematic or visceral disease, Ankylosing spondylitis, Spondylolysis and Spondylolisthesis, Vestibular dysfunctions, Body mass index (BMI) ≥ 30 kg/m2, Lower extremity injury within the past month, Concussion, Psychiatric, cardiovascular or musculoskeletal disorders, Vision problems, Vertebral fracture, Spinal Stenosis, Previous spinal surgery, Present pregnancy, Scoliosis, Inability to understand instructions, read or write (Li et al., 2021).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education

    Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education

    Outcomes

    Primary Outcome Measures

    Postural stability
    Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):
    Proprioception
    Ankle and Trunk Joint Position Sense (JPS)

    Secondary Outcome Measures

    Pain Intensity
    Visual Analog Scale (VAS)
    Pain Self-Efficacy Questionnaire (PSEQ-Ar)
    to examine one's beliefs, level of Pain intensity and actual achievements contributions to performance
    Activities-specific Balance Confidence (ABC)
    Active clinical assessment measures of balance and function
    Pain Catastrophizing Scale
    Overstressed undesirable perceptions of pain and the ambiance surrounding its involvement

    Full Information

    First Posted
    September 3, 2023
    Last Updated
    September 3, 2023
    Sponsor
    Imam Abdulrahman Bin Faisal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06030960
    Brief Title
    Effects of Virtual Reality Stabilization Training in Patients With Low Back Pain
    Acronym
    VR
    Official Title
    The Effects of Virtual Reality Stabilization Training on Postural Stability and Proprioception in Patients With Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 10, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2024 (Anticipated)
    Study Completion Date
    December 13, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Imam Abdulrahman Bin Faisal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The reversibility of LBP proprioceptive mechanism effects may give an insight into a treatment approach for postural stability. To our knowledge, no studies have better investigated the effect of Core Stabilization Exercises using VR on ankle and trunk proprioception in patients with CLBP and in turn on postural stability.
    Detailed Description
    Background: Low Back Pain (LBP), one of the most critical disability causatives, has been associated with neuromuscular and biomechanical manifestations related to the deficiency of postural control and stability. Virtual reality (VR) core stabilization exercises (CSE) has proven previously to be effective in improving postural control among conditions with different proprioceptive damage mechanisms other than those affected with LBP. The Aim of this study is to explore the differing effects of this treatment regimen on postural stability in relation to lumbar and ankle proprioception among in a population of participants with LBP. Design and Methods: a randomized clinical trial encompassing 44 participants of both genders. Participants with Chronic Low Back Pain (CLBP) will be randomized to one of two treatment groups: an Experimental group receiving VR stabilization exercises and a Control group receiving CSE only without VR simulations inaddition to patient instructions and education of both groups. Parameters of postural stability, ankle and trunk proprioception, pain intensity, balance interference with activity and psychological aspects of pain interference with activity will be measured by a force plate, iPhone applications, visual analog scale (VAS), the Activities-specific Balance Confidence (ABC) scale, Pain Catastrophizing Scale (PCS) and the Pain Self-Efficacy Questionnaire (PSEQ-Ar) respectively. Outcome measures will be collected at baseline, immediately after 1st treatment and after the last treatment session. Treatment regimens will consist of 12 sessions in 3 weeks using virtual reality glasses. Statistical Analysis: A mixed-model repeated-measures analysis of variance will be used to analyze within- and between-group differences at the baseline, 6th session and twelfth sessions (repeated measures will be set as GROUP with two levels and TIME with three levels). Bonferroni post-hoc procedures will be used for multiple comparisons of the differences over time. Intention-to-treat analysis shall be utilized. Statistical significance was set at P < 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    LBP, Psychological effects, Intervention, Virtual Reality, postural stability, balance, pain, COP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education
    Intervention Type
    Device
    Intervention Name(s)
    Virtual Reality (VR)
    Other Intervention Name(s)
    Exergames
    Intervention Description
    Virtual Reality (VR) Stabilization Exercises
    Intervention Type
    Other
    Intervention Name(s)
    Regular Exercises
    Intervention Description
    Regular Stabilization Exercises
    Intervention Type
    Other
    Intervention Name(s)
    patient instructions and education
    Intervention Description
    a unified form of patient instructions and education in regards of LBP
    Primary Outcome Measure Information:
    Title
    Postural stability
    Description
    Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):
    Time Frame
    12 weeks
    Title
    Proprioception
    Description
    Ankle and Trunk Joint Position Sense (JPS)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    Visual Analog Scale (VAS)
    Time Frame
    12 weeks
    Title
    Pain Self-Efficacy Questionnaire (PSEQ-Ar)
    Description
    to examine one's beliefs, level of Pain intensity and actual achievements contributions to performance
    Time Frame
    12 weeks
    Title
    Activities-specific Balance Confidence (ABC)
    Description
    Active clinical assessment measures of balance and function
    Time Frame
    12 weeks
    Title
    Pain Catastrophizing Scale
    Description
    Overstressed undesirable perceptions of pain and the ambiance surrounding its involvement
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients in Group 1 and Group 2 will be included if they: Are adults between 25 and 59 years of age. Have LBP for longer than 3 months. Are not currently undergoing medication or conservative treatment. Exclusion Criteria: Patients in these two groups will be excluded if they have: Nerve root manifestations (such as referred symptoms of radiating pain below the knee or paresthesia during the straight leg raise test), Systematic or visceral disease, Ankylosing spondylitis, Spondylolysis and Spondylolisthesis, Vestibular dysfunctions, Body mass index (BMI) ≥ 30 kg/m2, Lower extremity injury within the past month, Concussion, Psychiatric, cardiovascular or musculoskeletal disorders, Vision problems, Vertebral fracture, Spinal Stenosis, Previous spinal surgery, Present pregnancy, Scoliosis, Inability to understand instructions, read or write (Li et al., 2021).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abrar AlSadiq, MSC
    Phone
    00966565455689
    Email
    221070000@iau.edu.sa
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali AlShami, PhD
    Organizational Affiliation
    alshami@iau.edu.sa
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Virtual Reality Stabilization Training in Patients With Low Back Pain

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