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Completed

NCT Number: NCT06030960

Effects of Virtual Reality Stabilization Training 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.

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Key information

Age range

25 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dammam Medical Complex

Dammam, Eastern Province, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Virtual reality (VR)

Device

Virtual Reality (VR) Stabilization Exercises

Other names: Exergames

Regular Exercises

Other

Regular Stabilization Exercises

patient instructions and education

Other

a unified form of patient instructions and education in regards of LBP

Primary outcomes

  1. Postural stability

    Time frame: 12 weeks

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

  2. Proprioception

    Time frame: 12 weeks

    Ankle and Trunk Joint Position Sense (JPS)

Secondary outcomes

  1. Pain Intensity

    Time frame: 12 weeks

    Visual Analog Scale (VAS)

  2. 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

  3. Activities-specific Balance Confidence (ABC)

    Time frame: 12 weeks

    Active clinical assessment measures of balance and function

  4. Pain Catastrophizing Scale

    Time frame: 12 weeks

    Overstressed undesirable perceptions of pain and the ambiance surrounding its involvement

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

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

Acronym: VR

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 11, 2023
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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