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RecruitingNCT07876960Updated Oct 15, 2026

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

An interventional study of Virtual Reality and Spinal manipulation in Chronic Nonspecific Low-back Pain and CNSLBP, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Chronic Nonspecific Low-back Pain
  • CNSLBP

Keywords

  • Chronic Nonspecific Low Back pain
  • CNSLBP
  • Virtual Reality
  • VR
  • Spinal manipulation
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Virtual Reality

    The virtual reality group will participate in games designed to enhance strength and range of motion while activating postural muscles.

    Other: Virtual Reality

  • Experimental
    Spinal Manipulation

    The spinal manipulation group will receive lumbar spinal manipulation techniques designed to reduce pain and improve range of motion.

    Other: Spinal manipulation

Interventions

  • OtherVirtual Reality

    The participants will receive a single session of VR Exergames

  • OtherSpinal manipulation

    The participants will receive a single session of spinal manipulation

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).

Secondary outcomes

  1. 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.

    Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).

  2. Lumbar Range of Motion using a digital inclinometer

    This device measures range of motion including lumbar flexion, lumbar extension and side bending.

    Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).

  3. 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.

    Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).

  4. 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.

    Time frame: Pre-intervention, immediately post-intervention and follow up (1 week post-intervention).

07

Study locations

1 of 1 sites recruiting
  • Cairo University Hospitals
    Giza, Giza Governorate 2334, Egypt
    Recruiting
08

References and documents

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 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. PubMed 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. PubMed 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. PubMed 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. PubMed 39607680 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876960
Lead sponsor
Cairo University
Responsible party
Ahmed ElMelhat (Associate Professor of MSK Physiotherapy,BAU, Cairo University) — Principal investigator
First posted
Oct 15, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Ahmed El Melhat Associate Professor of MSK,BAU, PhD
Contact
ahmed.elmelhat@cau.edu.lb
+20 11 12595022
Ahmed El Melhat
study director · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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