Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain

NCT07876960 — Not applicable, Recruiting, 80 participants, Cairo University

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RegistryNCT07876960
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment80 (Estimated)
SponsorCairo University (Other)
ConditionsChronic Nonspecific Low-back Pain, CNSLBP
InterventionsVirtual Reality, Spinal manipulation (Other)
Datesstart 2026-10-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-10-15, last updated 2026-10-15
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Nonspecific Low-back Pain All trials for CNSLBP All trials of Virtual Reality All trials of Spinal manipulation

-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.

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Virtual RealityExperimentalOther: Virtual RealityThe virtual reality group will participate in games designed to enhance strength and range of motion while activating postural muscles.
Spinal ManipulationExperimentalOther: Spinal manipulationThe spinal manipulation group will receive lumbar spinal manipulation techniques designed to reduce pain and improve range of motion.
  • Virtual Reality (Other): The participants will receive a single session of VR Exergames
  • Spinal manipulation (Other): The participants will receive a single session of spinal manipulation

+Outcome measures

Primary outcomes

  • Pain intensity measured using the visual analogue Scale (VAS) [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).

Secondary outcomes

  • Kinesiophobia measured by the Tampa Scale of Kinesiophobia (TSK) [Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).]: 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.
  • Lumbar Range of Motion using a digital inclinometer [Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).]: This device measures range of motion including lumbar flexion, lumbar extension and side bending.
  • Mood states measured using the Arabic Brunel Mood Scale (BRUMS-AR) [Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).]: To evaluate the acute effect of the intervention on mood states. Scores range from 0 to 64, with higher scores indicating greater mood disturbance.
  • Functional disability measured using the Oswestry Disability Index (ODI) [Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).]: To assess disability related to low back pain. Scores range from 0 to 100, with higher scores indicating greater disability.

+Eligibility

Sex: All, ages: 20 Years to 55 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

+Locations (1)

FacilityCityCountryStatus
Cairo University HospitalsGiza, Giza GovernorateEgyptRecruiting

+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. PMID 38822395
  • Erol 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. PMID 39973277
  • Sampsonis 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. PMID 40724744
  • Hsieh 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. PMID 39746279
  • Massah 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. PMID 39607680

+Investigators