NCT07577778

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain intensity (VAS)

    1 Month

  • Functional disability (Oswestry Disability Index)

    1 Month

  • Lumbar reposition error (iPhone inclinometer)

    1 Month

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Participants in this group received conventional physiotherapy including TENS, therapeutic ultrasound, and proprioceptive exercises.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)Drug: Therapeutic UltrasoundOther: Proprioceptive Exercises

Group 2

EXPERIMENTAL

Participants in this group received the same conventional physiotherapy program in addition to virtual reality (VR) training.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)Drug: Therapeutic UltrasoundOther: Proprioceptive ExercisesDevice: Virtual Reality (VR) Training

Interventions

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.

Arm 1Group 2

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.

Arm 1Group 2

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.

Group 2

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.

Arm 1Group 2

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with low back pain ≥ 12 weeks Age: 21-45 years Both genders BMI: 18.5-24.9

You may not qualify if:

  • iabetic neuropathy Sciatica Spine deformities Previous lumbar surgery Neurological or vestibular disorders Visual disorders Malignancy or trauma Structural spinal disorders (stenosis, osteoporosis, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve StimulationUltrasonic Therapy

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaDiathermyHyperthermia, Induced

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

September 3, 2025

Primary Completion

April 15, 2026

Study Completion

April 30, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations