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Clinical Trials/NCT06030960
NCT06030960CompletedNot Applicable

The Effects of Virtual Reality Stabilization Training on Postural Stability and Proprioception in Patients With Low Back Pain

Imam Abdulrahman Bin Faisal University1 site in 1 country44 target enrollmentStarted: October 25, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Postural stability

Study Overview

Brief Summary

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 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 linear mixed model 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 59 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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,
  • •Inability to understand instructions, read or write (Li et al., 2021).

Arms & Interventions

Group 1

Experimental

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

Intervention: Virtual Reality (VR) (Device)

Group 1

Experimental

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

Intervention: Regular Exercises (Other)

Group 1

Experimental

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

Intervention: patient instructions and education (Other)

Group 2

Active Comparator

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

Intervention: Regular Exercises (Other)

Group 2

Active Comparator

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

Intervention: patient instructions and education (Other)

Outcomes

Primary Outcomes

Postural stability

Time Frame: 12 weeks

Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):

Proprioception

Time Frame: 12 weeks

Ankle and Trunk Joint Position Sense (JPS)

Secondary Outcomes

  • Pain Intensity(12 weeks)
  • Pain Self-Efficacy Questionnaire (PSEQ-Ar)(12 weeks)
  • Activities-specific Balance Confidence (ABC)(12 weeks)
  • Pain Catastrophizing Scale(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abrar AlSadiq

Rehabilitation Sciences PhD Student

Imam Abdulrahman Bin Faisal University

Study Sites (1)

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