Virtual Reality Rehabilitation in Neck Pain Subjects

NCT03987334 | Recruiting DMC

• 1 other identifier: VR-NECKPAIN
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

VR-NECKPAIN is a two-arm, monocentric, single-blind, randomized controlled trial in Neck Pain patients. The entire treatment consist in 12 sessions, each during 45 minutes, twice a week for 6 consecutive weeks. Subjects will be evaluated ad baseline (T0) and after six weeks of rehabilitation (T1). There will also be a 3 months Follow-Up assessment (T2). The total duration of study participation for each subject will be approximately 19 weeks, including evaluation at T0, treatment and evaluation at T1 and T2. Individuals in the experimental group (VRT) will undergo a virtual reality-based sensorimotor rehabilitation. Control group (CT) subjects will undergo the same rehabilitation of VR subjects, in terms of intensity, time and type, but with the virtual reality turned off.

Conditions

Neck Pain; Chronic Pain; Whiplash

Keywords

Virtual Reality; Motor Control; Augmented Feedback; Chronic Neck Pain; Whiplash

Outcome Measures

Primary Outcomes (1)

• Change in Neck Disability Index (NDI)

  The NDI is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The NDI consists of 10 questions in various domains: Pain Intensity, Personal care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping and Recreation. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). Total score is reported on a 0-50 scale.

  Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)

Secondary Outcomes (8)

• Change in Numeric Rating Scale (NRS)

  Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)

• Change in Neck and Pain Disability Scale (NPAD)

  Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)

• Change in Tampa Scale of Kinesiophobia (TSK)

  Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)

• Change in Active Range of Motion

  Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)

• Change in Conjunct Motion

  Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)

Study Arms (2)

Experimental Group (VRT)

EXPERIMENTAL

Subjects in the experimental group (VRT) will undergo 30 minutes of motor control exercises using a virtual reality-based sensorimotor rehabilitation provided using the Virtual Reality Rehabilitation System (VRRS) of Khymeia Group. The equipment includes a computer workstation connected to a 6 degrees of freedom (DOF) motion-tracking system (Polhemus G4, Vermont, US), a high-resolution LCD displaying the virtual scenarios on a large screen and a software processing the motion data coming: from the receiver of the sensors end-effectors placed on the sternum and on the head through a helmet. The system has been found to reliably record head position and cervical range of motion among asymptomatic people as well as persistent neck pain patients. The VRRS allows the participant to perform the requested motor tasks, while the movement of the system's end-effector is simultaneously represented in a virtual scenario.

Other: Virtual Reality Treatment

Control Group (CT)

ACTIVE COMPARATOR

Control group (CT) subjects will undergo the same treatment of VRT subjects in terms of intensity, time and type, but with the VR turned off.

Other: Control Group

Interventions

Control Group OTHER

Control Group (CT) subjects will undergo the same treatment of VRT subjects in terms of intensity, time and type, but with the VR turned off.

Also known as: Motor Control Rehabilitation

Control Group (CT)

Virtual Reality Treatment OTHER

Experimental Group (VRT) subjects will undergo Virtual Reality Motor Control exercises based on augmented feedback of their performance.

Also known as: Virtual Reality Motor Control Rehabilitation, Virtual Reality Augmented Feedback, Virtual Reality Rehabilitation System

Experimental Group (VRT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult individuals (18-70 years old);
• Neck Pain (Chronic Neck Pain or Whiplash);
• Normal vision or corrected vision.

You may not qualify if:

• Informed Consent negation;
• System infection or metabolic/neurological/muscular degenerative disorder;
• Cervical spinal pathology, fracture or surgery;
• Radiculopathy;
• Vestibular impairments;
• Epilepsy;
• Pregnancy.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCSS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Neck Pain; Chronic Pain; Whiplash Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neck Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Sandro Iannaccone, Dr

CONTACT

+39 0226435734; iannaccone.sandro@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 17, 2019
• Study Start: May 9, 2019
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)