Clinical trial NCT06030960: Effects of Virtual Reality Stabilization Training in Patients With Low Back Pain
Official title: The Effects of Virtual Reality Stabilization Training on Postural Stability and Proprioception in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: LBP
Psychological effects
Intervention
Virtual Reality
postural stability
balance
pain
COP
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 44
Sex: ALL
Minimum age (years): 25
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Postural stability
timeFrame: 12 weeks
measure: Proprioception
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain Intensity
timeFrame: 12 weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ-Ar)
timeFrame: 12 weeks
measure: Activities-specific Balance Confidence (ABC)
timeFrame: 12 weeks
measure: Pain Catastrophizing Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: alshami@iau.edu.sa
name: Ali AlShami, PhD
role: STUDY_CHAIR
References: