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

Not Applicable

Not yet recruiting

• Conditions: Low Back Pain
• Interventions: Other: Regular Exercises; Device: Virtual Reality (VR); Other: patient instructions and education

• Registration Number: NCT06030960
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

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.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-09-03
• Last Update Submitted: 2023-09-03
• Study Start: 2023-09-10
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-07-30
• Study Completion: 2025-12-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Regular Exercises	Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education
Group 1	Virtual Reality (VR)	Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education
Group 2	patient instructions and education	Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education
Group 1	patient instructions and education	Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education
Group 1	Regular Exercises	Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education

Primary Outcome Measures

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

Secondary Outcome Measures

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