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

June 25, 2025 updated by: Abrar AlSadiq, Imam Abdulrahman Bin Faisal University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Eastern
      • Dammam, Eastern, Saudi Arabia
        • Dammam Medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients in Group 1 and Group 2 will be included if they:

  1. Are adults between 25 and 59 years of age.
  2. Have LBP for longer than 3 months.
  3. Are not currently undergoing medication or conservative treatment.

Exclusion Criteria:

Patients in these two groups will be excluded if they have:

  1. Nerve root manifestations (such as referred symptoms of radiating pain below the knee or paresthesia during the straight leg raise test),
  2. Systematic or visceral disease,
  3. Ankylosing spondylitis, Spondylolysis and Spondylolisthesis,
  4. Vestibular dysfunctions,
  5. Body mass index (BMI) ≥ 30 kg/m2,
  6. Lower extremity injury within the past month,
  7. Concussion,
  8. Psychiatric, cardiovascular or musculoskeletal disorders,
  9. Vision problems,
  10. Vertebral fracture,
  11. Spinal Stenosis,
  12. Previous spinal surgery,
  13. Present pregnancy,
  14. Scoliosis,
  15. Inability to understand instructions, read or write (Li et al., 2021).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education
Device: Virtual Reality (VR)
Virtual Reality (VR) Stabilization Exercises
Other Names:
  • Exergames
Other: Regular Exercises
Regular Stabilization Exercises
Other: patient instructions and education
a unified form of patient instructions and education in regards of LBP
Active Comparator: Group 2
Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education
Other: Regular Exercises
Regular Stabilization Exercises
Other: patient instructions and education
a unified form of patient instructions and education in regards of LBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural stability
Time Frame: 12 weeks
Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):
12 weeks
Proprioception
Time Frame: 12 weeks
Ankle and Trunk Joint Position Sense (JPS)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 12 weeks
Visual Analog Scale (VAS)
12 weeks
Pain Self-Efficacy Questionnaire (PSEQ-Ar)
Time Frame: 12 weeks
to examine one's beliefs, level of Pain intensity and actual achievements contributions to performance
12 weeks
Activities-specific Balance Confidence (ABC)
Time Frame: 12 weeks
Active clinical assessment measures of balance and function
12 weeks
Pain Catastrophizing Scale
Time Frame: 12 weeks
Overstressed undesirable perceptions of pain and the ambiance surrounding its involvement
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Investigators

  • Study Chair: Ali AlShami, PhD, alshami@iau.edu.sa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Actual)

August 15, 2024

Study Completion (Actual)

May 13, 2025

Study Registration Dates

First Submitted

September 3, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-PGS-2023-03-097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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