NCT06750718

Brief Summary

The research aims to treat chronic non-specific neck pain using virtual reality (VR) technologies with sensory-motor training. Chronic neck pain is widespread and highly prevalent in Egyptian society due to many factors, such as sitting for long periods in front of a computer or smartphone, which leads to a decline in productivity at work and a constant feeling of fatigue. This problem is considered one of the widespread health problems that affect individuals of all ages and greatly affect their daily lives. This project was chosen based on the growing awareness of the need to search for innovative solutions to this health problem that hinders productivity and affects the general comfort of individuals. The reserch aims to integrate sensory-motor therapy with virtual reality, which helps patients improve movement and flexibility and reduce pain. It does this by simulating exciting interactive environments that engage their attention and help them relieve pain away from traditional treatment methods.

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 Jul 2024

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

December 16, 2024

Last Update Submit

March 29, 2026

Conditions

Keywords

Virtual Reality (VR)Non specific Neck Pain (NSNP)Neck-based Training Sensorimotor TrainingSensorimotor Training

Outcome Measures

Primary Outcomes (10)

  • Measurement of pain intensity (VAS)

    Asking the patient to put a horizontal mark on a continuous 10 cm line that represents his/her pain intensity, ranging from zero, which indicates no pain, or 29 discomfort to 10, which indicates the worst possible pain he could feel.

    Before Treatment and after 6 weeks of treatment

  • Measurement of disability due to neck pain (NDI)

    The patient will complete a condition-specific functional status questionnaire with 10 items. The NDI consists of 10 domains-pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep, and recreation-designed to assess the level of disability in patients with neck pain. Patients self-report their level of function/disability in each domain, after which a composite score is calculated.

    Before Treatment and after 6 weeks of treatment

  • Cervical proprioception and neck reposition sense

    Cervical joint position error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability.

    Before Treatment and after 6 weeks of treatment

  • Eye Movement Control (Gaze Stability)

    The Dynamic Visual Acuity (DVA) test is used for assessing gaze stability.

    Before Treatment and after 6 weeks of treatment

  • Cervical range of motion (ROM)

    Cervical ROM results were calculated by averaging the three best values from each direction

    Before Treatment and after 6 weeks of treatment

  • Cervical kinematics: Peak velocity (V peak /sec)

    Calculated as the maximal angular velocity, from motion initiation to target hit.

    Before Treatment and after 6 weeks of treatment

  • Cervical kinematics: Mean velocity (V mean /sec)

    The mean angular velocity angular velocity, from motion initiation to target hit

    Before Treatment and after 6 weeks of treatment

  • Cervical kinematics: Time to peak velocity percentage (TTP%)

    The time from motion initiation to peak velocity moment, as a percentage of total movement time, representing the ratio between the acceleration to deceleration phase in the velocity profile

    Before Treatment and after 6 weeks of treatment

  • Cervical kinematics: Static head stability (sway)

    The sway in pitch and yaw from the mid-position and calculated in terms of 3D mean and standard deviation amplitude

    Before Treatment and after 6 weeks of treatment

  • Cervical kinematics: Head movement accuracy

    Motion accuracy was defined as the difference between the target position and the participant's head location. This difference (target position- player's head position)

    Before Treatment and after 6 weeks of treatment

Study Arms (2)

Virtual Reality

EXPERIMENTAL

The virtual reality group will engage in targeted cervical sensorimotor training through VR Oculus Quest 2 (OQ2)

Device: Virtual Reality (VR)

Comprehensive Sensorimotor Training

ACTIVE COMPARATOR

An exercise program consisting of Cervical JPSM, Cervical movement sense, and Oculomotor control exercises.

Other: Comprehensive Sensorimotor Training

Interventions

An exercise program consisting of Cervical JPSM, Cervical movement sense, and Oculomotor control exercises.

Comprehensive Sensorimotor Training

Oculus Quest 2 (OQ2) advanced 256 GB all-in-one virtual reality headset, Wi-Fi will be used.

Also known as: Oculus Quest 2 (OQ2)
Virtual Reality

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fifty patients diagnosed with mechanical neck pain between 18- and 40 years old with mechanical neck pain.
  • Patients with pain intensity scores (\>3) on the visual analog scale (VAS; 0-100mm) for an average of three weeks before the study.
  • Neck Disability Index (NDI) scoring 20%-60% (\>6) (moderate to severe disability).

You may not qualify if:

  • Any history of lower extremity or spine trauma or surgery, recognized and observable spinal deformity, neurological disorders, cervical fracture/dislocation, whiplash injuries, neurological/cardiovascular/respiratory disorders affecting patients' physical performance, or inability to provide informed consent.
  • Benign paroxysmal positional vertigo (BPPV), as confirmed by the Dix Hallpike test.
  • Pregnancy.
  • Patients who had received physical therapy interventions for neck pain within three months preceding the study were also ineligible for participation and were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Cairo, Egypt

Location

Physical Therapy

Cairo, Egypt

Location

Study Officials

  • Hadeer Maghraby, MSc

    Assistant Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A blinded researcher will assess the patients during the trial, blinding will not be feasible for participants or therapists due to the layout of the VR therapy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Fifty patients with mechanical neck pain patients will be randomly allocated into 2 equal groups; group (A) received VR neck-based sensorimotor training only, group (B) received comprehensive sensorimotor training only. (Parallel Group Two-Armed Comparative Randomized Controlled Trial)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Orthopedic Physiotherapy in MTI University

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 27, 2024

Study Start

July 1, 2024

Primary Completion

December 30, 2025

Study Completion

March 30, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations