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

Sponsor

Imam Abdulrahman Bin Faisal University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06030960

Collaborator

(none)

Enrollment

Arms

27.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Device: Virtual Reality (VR) Other: Regular Exercises Other: patient instructions and education	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 10, 2023

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Dec 13, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).