NCT07876960

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Oct 2026Jan 2027

Study Start

First participant enrolled

October 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

2 months

First QC Date

October 9, 2026

Last Update Submit

October 9, 2026

Conditions

Keywords

Chronic Nonspecific Low Back painCNSLBPVirtual RealityVRSpinal manipulation

Outcome Measures

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).

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

Secondary Outcomes (4)

  • Kinesiophobia measured by the Tampa Scale of Kinesiophobia (TSK)

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

  • Lumbar Range of Motion using a digital inclinometer

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

  • Mood states measured using the Arabic Brunel Mood Scale (BRUMS-AR)

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

  • Functional disability measured using the Oswestry Disability Index (ODI)

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

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

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.

Other: Spinal manipulation

Interventions

The participants will receive a single session of VR Exergames

Virtual Reality

The participants will receive a single session of spinal manipulation

Spinal Manipulation

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Giza, Giza Governorate, 2334, Egypt

RECRUITING

Related Publications (5)

  • 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: 38822395BACKGROUND
  • 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: 39973277BACKGROUND
  • 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: 40724744BACKGROUND
  • 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: 39746279BACKGROUND
  • 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: 39607680BACKGROUND

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Ahmed El Melhat

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ahmed El Melhat Associate Professor of MSK,BAU, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of MSK Physiotherapy,BAU

Study Record Dates

First Submitted

October 9, 2026

First Posted

October 15, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

October 15, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations