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

NCT ID: NCT06030960

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2025-05-13

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Virtual Reality (VR)

Intervention Type: DEVICE

Virtual Reality (VR) Stabilization Exercises

Regular Exercises

Intervention Type: OTHER

Regular Stabilization Exercises

patient instructions and education

Intervention Type: OTHER

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

Group 2

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

Group Type: ACTIVE_COMPARATOR

Regular Exercises

Intervention Type: OTHER

Regular Stabilization Exercises

patient instructions and education

Intervention Type: OTHER

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

Interventions

Virtual Reality (VR)

Virtual Reality (VR) Stabilization Exercises

Intervention Type: DEVICE

Regular Exercises

Regular Stabilization Exercises

Intervention Type: OTHER

patient instructions and education

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

Intervention Type: OTHER

Other Intervention Names

Exergames

Eligibility Criteria

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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role: lead

Responsible Party

Abrar AlSadiq

Rehabilitation Sciences PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali AlShami, PhD

Role: STUDY_CHAIR

alshami@iau.edu.sa

Locations

Dammam Medical Complex

Dammam, Eastern Province, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

IRB-PGS-2023-03-097

Identifier Type: -

Identifier Source: org_study_id