Low Back PainVRNCT06030960
Effects of Virtual Reality Stabilization Training in Patients With Low Back Pain
A study testing Virtual Reality (VR), Regular Exercises and patient instructions and education in people with Low Back Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 59 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Virtual Reality (VR), Regular Exercises and patient instructions and education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Oct 2023to 13 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 16Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Virtual Reality Stabilization Training on Postural Stability and Proprioception in Patients With Low Back Pain
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.
Read the 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
- Being tested
- Virtual Reality (VR), Regular Exercises, patient instructions and education
- Keywords
- LBP, Psychological effects, Intervention, Virtual Reality, postural stability, balance, pain, COP
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR)Device
Also called Exergames
Virtual Reality (VR) Stabilization Exercises
Regular ExercisesOther
Regular Stabilization Exercises
patient instructions and educationOther
a unified form of patient instructions and education in regards of LBP
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education Receives: Device: Virtual Reality (VR); Other: Regular Exercises; Other: patient instructions and education |
| Group 2 | Active comparator | Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education Receives: Other: Regular Exercises; Other: patient instructions and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability
Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):
Measured: 12 weeks
Proprioception
Ankle and Trunk Joint Position Sense (JPS)
Measured: 12 weeks
Secondary outcomes (4)
Pain Intensity
Visual Analog Scale (VAS)
Measured: 12 weeks
Pain Self-Efficacy Questionnaire (PSEQ-Ar)
to examine one's beliefs, level of Pain intensity and actual achievements contributions to performance
Measured: 12 weeks
Activities-specific Balance Confidence (ABC)
Active clinical assessment measures of balance and function
Measured: 12 weeks
Pain Catastrophizing Scale
Overstressed undesirable perceptions of pain and the ambiance surrounding its involvement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start25 Oct 2023
- Primary completion15 Aug 2024
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abrar AlSadiq, Imam Abdulrahman Bin Faisal University
- Investigators
- Ali AlShami, PhD, Study chair, alshami@iau.edu.sa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030960
- Sponsor's protocol ID
- IRB-PGS-2023-03-097
- Acronym
- VR
- Status last verified
- Jun 2025
- First submitted
- 3 Sep 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality Stabilization Training on Postural Stability and Proprioception in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT06030960
- Acronym / sponsor ID
- VR / IRB-PGS-2023-03-097
- Conditions
- Low Back Pain
- Keywords
- LBP, Psychological effects, Intervention, Virtual Reality, postural stability, balance, pain, COP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Virtual Reality (VR), Other: Regular Exercises, Other: patient instructions and educationPatients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education |
| Group 2 | Active comparator | Other: Regular Exercises, Other: patient instructions and educationPatients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are adults between 25 and 59 years of age.
- Have LBP for longer than 3 months.
- Are not currently undergoing medication or conservative treatment.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR)Also: ExergamesVirtual Reality (VR) Stabilization Exercises | Device | Group 1 |
| Regular ExercisesRegular Stabilization Exercises | Other | Group 1, Group 2 |
| patient instructions and educationa unified form of patient instructions and education in regards of LBP | Other | Group 1, Group 2 |
Primary outcome
Postural stability
Time frame: 12 weeks
Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):
Proprioception
Time frame: 12 weeks
Ankle and Trunk Joint Position Sense (JPS)
4 secondary outcomes
Pain Intensity
Time frame: 12 weeks
Pain Self-Efficacy Questionnaire (PSEQ-Ar)
Time frame: 12 weeks
Activities-specific Balance Confidence (ABC)
Time frame: 12 weeks
Pain Catastrophizing Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali AlShami, PhD study chair
alshami@iau.edu.sa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR), Regular Exercises and patient instructions and education in people with Low Back Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural stability (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.