Non Specific Chronic Low Back PainNCT07577778
Effect of Virtual Reality Training on Pain, Functional Disability, and Lumbar Reposition Error in Patients With Chronic Non-Specific Low Back Pain
A study testing Transcutaneous Electrical Nerve Stimulation (TENS), Therapeutic Ultrasound and Proprioceptive Exercises in people with Non Specific Chronic Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of virtual reality (VR) training on pain intensity, functional disability, and lumbar reposition error in patients with chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Non Specific Chronic Low Back Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS), Therapeutic Ultrasound and Proprioceptive Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2025to 30 Apr 2026
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with low back pain ≥ 12 weeks Age: 21-45 years Both genders BMI: 18.5-24.9
Who cannot join
- iabetic neuropathy Sciatica Spine deformities Previous lumbar surgery Neurological or vestibular disorders Visual disorders Malignancy or trauma Structural spinal disorders (stenosis, osteoporosis, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Training on Pain, Functional Disability, and Lumbar Reposition Error in Patients With Chronic Non-Specific Low Back Pain: A Randomized Control Trial
This study aims to investigate the effect of virtual reality (VR) training on pain intensity, functional disability, and lumbar reposition error in patients with chronic non-specific low back pain.
Read the detailed description
This randomized controlled trial was conducted to evaluate the effectiveness of virtual reality (VR) training in patients with chronic non-specific low back pain (CNSLBP). Chronic low back pain is a highly prevalent condition associated with impaired proprioception, altered motor control, and functional disability.
Fifty participants diagnosed with CNSLBP were randomly assigned into two groups. The intervention group received virtual reality-based training in addition to conventional physiotherapy, while the control group received conventional treatment alone.
Outcome measures included pain intensity assessed by the Visual Analogue Scale (VAS), functional disability assessed by the Oswestry Disability Index (ODI), and lumbar repositioning error measured using an iPhone inclinometer application.
The study aimed to determine whether VR training could significantly improve pain, functional outcomes, and proprioceptive accuracy in this population.
- Conditions
- Non Specific Chronic Low Back Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS), Therapeutic Ultrasound, Proprioceptive Exercises, Virtual Reality (VR) Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
TENS was applied in a prone position with electrodes placed over the painful area. Low-frequency stimulation (2-10 Hz) was used to achieve analgesic effects. Intensity was adjusted to produce a strong but comfortable tingling sensation. Each session lasted 20-60 minutes.
Therapeutic UltrasoundDrug
Ultrasound therapy was applied using appropriate frequency (1 MHz for deep tissues, 3 MHz for superficial tissues) and intensity (0.5-2.0 W/cm²). Continuous or pulsed modes were selected based on the condition. Each session lasted 5-10 minutes.
Proprioceptive ExercisesOther
Participants performed trunk stabilization exercises including supine bridge, supine bridge on Swiss ball, and prone plank. Each exercise was performed for 30 seconds with 30 seconds rest, repeated 5 times, 3 sets per session, 3 times per week.
Virtual Reality (VR) TrainingDevice
Participants underwent VR training using Xbox 360 Kinect system. The setup included a motion sensor and projector, allowing full-body interaction through game-based activities.
Training consisted of interactive games (e.g., rafting, running, ball hitting) designed to improve trunk control and motor function. Sessions were conducted twice weekly for 30 minutes over 12 weeks. Exercises included movements such as jumping, trunk tilting, and arm coordination, with progressive difficulty levels.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Participants in this group received conventional physiotherapy including TENS, therapeutic ultrasound, and proprioceptive exercises. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Drug: Therapeutic Ultrasound; Other: Proprioceptive Exercises |
| Group 2 | Experimental | Participants in this group received the same conventional physiotherapy program in addition to virtual reality (VR) training. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Drug: Therapeutic Ultrasound; Other: Proprioceptive Exercises; Device: Virtual Reality (VR) Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (VAS)
Measured: 1 Month
Functional disability (Oswestry Disability Index)
Measured: 1 Month
Lumbar reposition error (iPhone inclinometer)
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start3 Sep 2025
- Primary completion15 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Osama, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577778
- Sponsor's protocol ID
- P.T.REC/012/00604
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Training on Pain, Functional Disability, and Lumbar Reposition Error in Patients With Chronic Non-Specific Low Back Pain: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07577778
- Acronym / sponsor ID
- P.T.REC/012/00604
- Conditions
- Non Specific Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 11 May 2026 (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.
This study aims to investigate the effect of virtual reality (VR) training on pain intensity, functional disability, and lumbar reposition error in patients with chronic non-specific low back pain.
Detailed description
This randomized controlled trial was conducted to evaluate the effectiveness of virtual reality (VR) training in patients with chronic non-specific low back pain (CNSLBP). Chronic low back pain is a highly prevalent condition associated with impaired proprioception, altered motor control, and functional disability.
Fifty participants diagnosed with CNSLBP were randomly assigned into two groups. The intervention group received virtual reality-based training in addition to conventional physiotherapy, while the control group received conventional treatment alone.
Outcome measures included pain intensity assessed by the Visual Analogue Scale (VAS), functional disability assessed by the Oswestry Disability Index (ODI), and lumbar repositioning error measured using an iPhone inclinometer application.
The study aimed to determine whether VR training could significantly improve pain, functional outcomes, and proprioceptive accuracy in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS), Drug: Therapeutic Ultrasound, Other: Proprioceptive ExercisesParticipants in this group received conventional physiotherapy including TENS, therapeutic ultrasound, and proprioceptive exercises. |
| Group 2 | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS), Drug: Therapeutic Ultrasound, Other: Proprioceptive Exercises, Device: Virtual Reality (VR) TrainingParticipants in this group received the same conventional physiotherapy program in addition to virtual reality (VR) training. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with low back pain ≥ 12 weeks Age: 21-45 years Both genders BMI: 18.5-24.9
Key exclusion criteria (1 listed)
- iabetic neuropathy Sciatica Spine deformities Previous lumbar surgery Neurological or vestibular disorders Visual disorders Malignancy or trauma Structural spinal disorders (stenosis, osteoporosis, etc.)
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)TENS was applied in a prone position with electrodes placed over the painful area. Low-frequency stimulation (2-10 Hz) was used to achieve analgesic effects. Intensity was adjusted to produce a strong but comfortable tingling sensation. Each session lasted 20-60 minutes. | Device | Arm 1, Group 2 |
| Therapeutic UltrasoundUltrasound therapy was applied using appropriate frequency (1 MHz for deep tissues, 3 MHz for superficial tissues) and intensity (0.5-2.0 W/cm²). Continuous or pulsed modes were selected based on the condition. Each session lasted 5-10 minutes. | Drug | Arm 1, Group 2 |
| Proprioceptive ExercisesParticipants performed trunk stabilization exercises including supine bridge, supine bridge on Swiss ball, and prone plank. Each exercise was performed for 30 seconds with 30 seconds rest, repeated 5 times, 3 sets per session, 3 times per week. | Other | Arm 1, Group 2 |
| Virtual Reality (VR) TrainingParticipants underwent VR training using Xbox 360 Kinect system. The setup included a motion sensor and projector, allowing full-body interaction through game-based activities. Training consisted of interactive games (e.g., rafting, running, ball hitting) designed to improve trunk control and motor function. Sessions were conducted twice weekly for 30 minutes over 12 weeks. Exercises included movements such as jumping, trunk tilting, and arm coordination, with progressive difficulty levels. | Device | Group 2 |
Primary outcome
Pain intensity (VAS)
Time frame: 1 Month
Functional disability (Oswestry Disability Index)
Time frame: 1 Month
Lumbar reposition error (iPhone inclinometer)
Time frame: 1 Month
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 11 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS), Therapeutic Ultrasound and Proprioceptive Exercises in people with Non Specific Chronic Low Back Pain, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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 11 May 2026. 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 Egypt. 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?
Pain intensity (VAS) (time frame: 1 Month). The study lists 3 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 11 May 2026.