Chronic Nonspecific Low-back PainNCT07876960
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
A study testing Virtual Reality and Spinal manipulation in people with Chronic Nonspecific Low-back Pain and CNSLBP, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the acute effects of virtual reality exergames (VR-EXG) and spinal manipulation on pain, kinesiophobia, mood states, functional disability and lumbar range of motion in individuals with chronic nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chronic Nonspecific Low-back Pain, CNSLBP
- What is being tested?
- Virtual Reality and Spinal manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 20-55 years
- Chronic nonspecific low back pain lasting at least 3 months.
- Pain intensity of ≥3/10 on the VAS at baseline.
- Ability to understand and follow the instructions and complete the VR-EXG and spinal-manipulation procedures.
- Ability to perform the required lumbar movements.
Who cannot join
- Specific spinal pathology, including fracture, spinal infection, malignancy, inflammatory/rheumatologic disease, or severe osteoporosis.
- Previous lumbar or spinal surgery.
- Neurological conditions or progressive neurological deficits, including significant radicular symptoms.
- Serious cardiovascular, systemic, or other medical conditions that contraindicate physical exercise or spinal manipulation.
- Pregnancy.
- Current acute injury or condition that would prevent safe participation in VR-EXG or spinal manipulation.
Show all 11Show fewer
- Previous adverse reaction or contraindication to spinal manipulation.
- Vestibular disorders, severe dizziness, or other conditions that could interfere with safe VR use.
- Significant visual or auditory impairment that prevents participation in the VR intervention.
- Inability to understand or perform the intervention or outcome assessments.
- Use of analgesic medication within 48 hours before assessment/intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Giza, Giza Governorate, 2334
Ahmed ElMelhat, PhD, 01112595022, ahmed.elmelhat@cu.edu.eg
About this study
The goal of this clinical trial is to compare the acute effects of virtual reality exergames (VR-EXG) and spinal manipulation on pain, kinesiophobia, mood states, functional disability and lumbar range of motion in individuals with chronic nonspecific low back pain.
The main questions it aims to answer are:
Read more
- Does a single session of VR-EXG affect pain, kinesiophobia, mood states, functional disability and lumbar range of motion in individuals with chronic nonspecific low back pain?
- Does a single session of spinal manipulation affect pain, kinesiophobia, mood states, functional disability and lumbar range of motion in individuals with chronic nonspecific low back pain?
- Is there a difference between VR-EXG and spinal manipulation in their acute effects on pain, kinesiophobia, mood states, functional disability and lumbar range of motion?
Researchers will compare participants receiving VR-EXG with those receiving spinal manipulation to determine whether one intervention produces greater acute improvements in pain, kinesiophobia, mood states, functional disability and lumbar range of motion.
Participants will be divided into two groups to be compared: the first group will receive virtual reality exergaming (VR-EXG), while the second group will receive spinal manipulation.
Read the detailed description
Virtual reality (VR) is an emerging rehabilitation approach that can reduce pain , Kinesiophobia and functional disability in people with chronic nonspecific low back pain (CNSLBP). Spinal manipulation is a commonly used manual therapy that can provide short-term pain relief and improve physical function in CNSLBP. Both interventions may also influence psychological responses associated with chronic pain, including mood states and kinesiophobia. However, most studies have investigated VR and spinal manipulation separately rather than directly comparing their acute effects. Therefore, it remains unclear which intervention produces greater immediate improvements in pain, lumbar range of motion, mood states, functional disability and kinesiophobia. Comparing these interventions may address this gap and provide evidence on their relative acute effects in individuals with CNSLBP.
- Conditions
- Chronic Nonspecific Low-back Pain, CNSLBP
- Being tested
- Virtual Reality, Spinal manipulation
- Keywords
- Low Back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
The participants will receive a single session of VR Exergames
Spinal manipulationOther
The participants will receive a single session of spinal manipulation
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | The virtual reality group will participate in games designed to enhance strength and range of motion while activating postural muscles. Receives: Other: Virtual Reality |
| Spinal Manipulation | Experimental | The spinal manipulation group will receive lumbar spinal manipulation techniques designed to reduce pain and improve range of motion. Receives: Other: Spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured using the visual analogue Scale (VAS)
To evaluate the acute effect of the intervention on pain intensity. Scores range from 0 (no pain) to 10 ( worst pain).
Measured: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Secondary outcomes (4)
Kinesiophobia measured by the Tampa Scale of Kinesiophobia (TSK)
To assess the acute effect of the intervention on Kinesiophobia . The Total score ranges from 17 to 68 , with higher scores indicating greater Kinesiophobia and Scores above 37 indicating clinically relevant Kinesiophobia.
Measured: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Lumbar Range of Motion using a digital inclinometer
This device measures range of motion including lumbar flexion, lumbar extension and side bending.
Measured: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Mood states measured using the Arabic Brunel Mood Scale (BRUMS-AR)
To evaluate the acute effect of the intervention on mood states. Scores range from 0 to 64, with higher scores indicating greater mood disturbance.
Measured: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Functional disability measured using the Oswestry Disability Index (ODI)
To assess disability related to low back pain. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start20 Oct 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonspecific 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmed El Melhat, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876960
- Sponsor's protocol ID
- VR vs manipulation in CNSLBP
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freitas JP, Correa LA, Bittencourt JV, Armstrong KM, Meziat-Filho N, Nogueira LAC. One spinal manipulation session reduces local pain sensitivity but does not affect postural stability in individuals with chronic low back pain: a randomised, placebo-controlled trial. Chiropr Man Therap. 2024 May 31;32(1):20. doi: 10.1186/s12998-024-00541-4.
PubMed 38822395Erol E, Burak M, Elbasan B. Effects of instrument-assisted manipulation and mobilization with movement in chronic non-specific low back pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2025 May;38(3):640-650. doi: 10.1177/10538127241309343. Epub 2025 Feb 11.
PubMed 39973277Sampsonis T, Karanasios S, Gioftsos G. The Immediate Hypoalgesic Effects of Mobilization and Manipulation in Patients with Non-Specific Chronic Low Back Pain: A Cross-Over Randomized Controlled Trial. Healthcare (Basel). 2025 Jul 17;13(14):1719. doi: 10.3390/healthcare13141719.
PubMed 40724744Hsieh RL, Chen YR, Lee WC. Short-term effects of exergaming on patients with chronic low back pain: A single-blind randomized controlled trial. Musculoskelet Sci Pract. 2025 Feb;75:103248. doi: 10.1016/j.msksp.2024.103248. Epub 2024 Dec 22.
PubMed 39746279Massah N, Kahrizi S, Neblett R. Comparison of the Acute Effects of Virtual Reality Exergames and Core Stability Exercises on Cognitive Factors, Pain, and Fear Avoidance Beliefs in People with Chronic Nonspecific Low Back Pain. Games Health J. 2025 Jun;14(3):233-241. doi: 10.1089/g4h.2024.0003. Epub 2024 Nov 28.
PubMed 39607680
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT07876960
- Acronym / sponsor ID
- VR vs manipulation in CNSLBP
- Conditions
- Chronic Nonspecific Low-back Pain, CNSLBP
- Keywords
- Low Back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 15 Oct 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.
The goal of this clinical trial is to compare the acute effects of virtual reality exergames (VR-EXG) and spinal manipulation on pain, kinesiophobia, mood states, functional disability and lumbar range of motion in individuals with chronic nonspecific low back pain.
The main questions it aims to answer are:
- Does a single session of VR-EXG affect pain, kinesiophobia, mood states, functional disability and lumbar range of motion in individuals with chronic nonspecific low back pain?
- Does a single session of spinal manipulation affect pain, kinesiophobia, mood states, functional disability and lumbar range of motion in individuals with chronic nonspecific low back pain?
- Is there a difference between VR-EXG and spinal manipulation in their acute effects on pain, kinesiophobia, mood states, functional disability and lumbar range of motion?
Researchers will compare participants receiving VR-EXG with those receiving spinal manipulation to determine whether one intervention produces greater acute improvements in pain, kinesiophobia, mood states, functional disability and lumbar range of motion.
Participants will be divided into two groups to be compared: the first group will receive virtual reality exergaming (VR-EXG), while the second group will receive spinal manipulation.
Detailed description
Virtual reality (VR) is an emerging rehabilitation approach that can reduce pain , Kinesiophobia and functional disability in people with chronic nonspecific low back pain (CNSLBP). Spinal manipulation is a commonly used manual therapy that can provide short-term pain relief and improve physical function in CNSLBP. Both interventions may also influence psychological responses associated with chronic pain, including mood states and kinesiophobia. However, most studies have investigated VR and spinal manipulation separately rather than directly comparing their acute effects. Therefore, it remains unclear which intervention produces greater immediate improvements in pain, lumbar range of motion, mood states, functional disability and kinesiophobia. Comparing these interventions may address this gap and provide evidence on their relative acute effects in individuals with CNSLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual RealityThe virtual reality group will participate in games designed to enhance strength and range of motion while activating postural muscles. |
| Spinal Manipulation | Experimental | Other: Spinal manipulationThe spinal manipulation group will receive lumbar spinal manipulation techniques designed to reduce pain and improve range of motion. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 20-55 years
- Chronic nonspecific low back pain lasting at least 3 months.
- Pain intensity of ≥3/10 on the VAS at baseline.
- Ability to understand and follow the instructions and complete the VR-EXG and spinal-manipulation procedures.
- Ability to perform the required lumbar movements.
Key exclusion criteria (11 listed)
- Specific spinal pathology, including fracture, spinal infection, malignancy, inflammatory/rheumatologic disease, or severe osteoporosis.
- Previous lumbar or spinal surgery.
- Neurological conditions or progressive neurological deficits, including significant radicular symptoms.
- Serious cardiovascular, systemic, or other medical conditions that contraindicate physical exercise or spinal manipulation.
- Pregnancy.
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 RealityThe participants will receive a single session of VR Exergames | Other | Virtual Reality |
| Spinal manipulationThe participants will receive a single session of spinal manipulation | Other | Spinal Manipulation |
Primary outcome
Pain intensity measured using the visual analogue Scale (VAS)
Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
To evaluate the acute effect of the intervention on pain intensity. Scores range from 0 (no pain) to 10 ( worst pain).
4 secondary outcomes
Kinesiophobia measured by the Tampa Scale of Kinesiophobia (TSK)
Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Lumbar Range of Motion using a digital inclinometer
Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Mood states measured using the Arabic Brunel Mood Scale (BRUMS-AR)
Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Functional disability measured using the Oswestry Disability Index (ODI)
Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 38822395Freitas JP, Correa LA, Bittencourt JV, Armstrong KM, Meziat-Filho N, Nogueira LAC. One spinal manipulation session reduces local pain sensitivity but does not affect postural stability in individuals with chronic low back pain: a randomised, placebo-controlled trial. Chiropr Man Therap. 2024 May 31;32(1):20. doi: 10.1186/s12998-024-00541-4.
- Background: PubMed 39973277Erol E, Burak M, Elbasan B. Effects of instrument-assisted manipulation and mobilization with movement in chronic non-specific low back pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2025 May;38(3):640-650. doi: 10.1177/10538127241309343. Epub 2025 Feb 11.
- Background: PubMed 40724744Sampsonis T, Karanasios S, Gioftsos G. The Immediate Hypoalgesic Effects of Mobilization and Manipulation in Patients with Non-Specific Chronic Low Back Pain: A Cross-Over Randomized Controlled Trial. Healthcare (Basel). 2025 Jul 17;13(14):1719. doi: 10.3390/healthcare13141719.
- Background: PubMed 39746279Hsieh RL, Chen YR, Lee WC. Short-term effects of exergaming on patients with chronic low back pain: A single-blind randomized controlled trial. Musculoskelet Sci Pract. 2025 Feb;75:103248. doi: 10.1016/j.msksp.2024.103248. Epub 2024 Dec 22.
- Background: PubMed 39607680Massah N, Kahrizi S, Neblett R. Comparison of the Acute Effects of Virtual Reality Exergames and Core Stability Exercises on Cognitive Factors, Pain, and Fear Avoidance Beliefs in People with Chronic Nonspecific Low Back Pain. Games Health J. 2025 Jun;14(3):233-241. doi: 10.1089/g4h.2024.0003. Epub 2024 Nov 28.
- Individual participant dataSharing planned: No
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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.
Ahmed El Melhat study director
Cairo University
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 and Spinal manipulation in people with Chronic Nonspecific Low-back Pain and CNSLBP, 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El Melhat Associate Professor of MSK,BAU, PhD (+20 11 12595022, ahmed.elmelhat@cau.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured using the visual analogue Scale (VAS) (time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07876960, which also lists 5 linked publications.
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 30 Oct 2026.