NCT06159413

Brief Summary

Abstract: Background: The multifidus muscle, the most medially located back muscle and the largest muscle that spans the lumbosacral junction serves to provide dynamic stability to the spinal column. Virtual reality and core stabilization exercises are commonly used for balance training in musculoskeletal conditions. The knowledge regarding the effective implementation of these training protocols in patients suffering from chronic low back pain (LBP) is insufficient. Objective: The purpose of the present study is to investigate the efficacy of virtual reality versus stabilization exercises on lumbar multifidus muscle function among patients with low back pain. Design: Randomized, double-blinded controlled study. Participants: Sixty LBP participants will be divided into three groups in a 1:1:1 ratio, 20 in each group (control group, stabilizing exercises, and virtual reality rehabilitation system). All three groups received training three days per week throughout the Six-week treatment session. Outcome measures: Evaluation of pain by the visual analog scale (VAS), Level of functional impairments by Oswestry Disability Index and Accuracy of lumbar repositioning measurement by Biodex system will be measured at baseline and after Six weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 28, 2023

Last Update Submit

November 28, 2023

Conditions

Keywords

Pain

Outcome Measures

Primary Outcomes (3)

  • Evaluation of pain

    The visual analog scale (VAS) is a 10 cm line with 0 representing no pain and 10 representing the worst pain. It will be used to ask patients to rate how much pain they perceived. They will be told to draw a mark on the line where their level of pain will be.

    6 weeks

  • Level of functional impairments

    To assess functional disability, we employed the Oswestry Disability Index. Ten multiple-choice questions about back discomfort and everyday activities are included. Each question has six potential answers and a maximum score of 5. Based on a few chosen statements, the ultimate score is determined.

    6 weeks

  • Accuracy of lumbar repositioning measurement

    Knee blocks, leg pads, thigh straps, pelvic brace, lumbar pad, and force application straps will be used to position the person in the Biodex system. The head will be supported on a flexible rest while straps restrained the torso. The spinal range of motion created a neutral spinal posture at 30 degrees lumbar flexion. We asked participants to bend their backs as far as possible to determine the range of motion. For consistency, the dynamometer will be adjusted at zero degrees. Participants will be instructed to recall and replicate a 30° position in a practice trial. We ran this test thrice and calculated the mean deviation each time.

    6 weeks

Interventions

LUMBAR MULTIFIDUS MUSCLES FUNCTION AMONG PATIENTS WITH LOW BACK PAIN: VIRTUAL REALITY VERSUS STABILIZATION EXERCISES.

Also known as: STABILIZATION EXERCISES

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with low back pain.

You may not qualify if:

  • Patients with pain more than 8 according to VAS.
  • Any joint problems.
  • Any surgical intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed raafat Atteya

Ha'il, Ha'il Region, 2375, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sixty LBP participants will be divided into three groups in a 1:1:1 ratio, 20 in each group (control group, stabilizing exercises, and virtual reality rehabilitation system). All three groups received training three days per week throughout the Six-week treatment session.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blinded controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 6, 2023

Study Start

March 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations