Clinical trial NCT03987334: Virtual Reality Rehabilitation in Neck Pain Subjects
Official title: Effects of Virtual Reality Motor Control Rehabilitation in Neck Pain Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Chronic Pain
Whiplash
Keywords: Virtual Reality
Motor Control
Augmented Feedback
Chronic Neck Pain
Whiplash
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: VR-NECKPAIN is a monocentric, single-blind, randomized controlled trial in Neck Pain patients.

Subjects will receive rehabilitation treatment twice a week, for six consecutive weeks. Subjects will be evaluated ad baseline (T0) and after six weeks of rehabilitation (T1). Also there will 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.

The study is conducted from March 2019 and the conclusion is planned to March 2023.

Patients with Neck Pain will be enrolled at the Department of Rehabilitation and Functional Recovery of San Raffaele Hospital, via Olgettina 60, Milan.

The treatment will last 45 minutes, 2 sessions per week for a total of 6 weeks. The first 15 minutes of treatment will consist, for each group, in manual therapy treatment, such as mobilization, manipulation, trigger-points treatment, tailored on the individual.

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.

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.

In addition, all subjects will be educated in emphasizing self-management and return to normal function.

A blind assessor will be present in our study. In order to maintain him/her blind, treatments on patients will never take place in presence of the assessor.

Forty healthy subjects, matched for age and sex to the studied population, will also be enrolled in order to obtain normative data to compare with neck pain subjects.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Neck Disability Index (NDI)
timeFrame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
Secondary outcomes:
measure: Change in Numeric Rating Scale (NRS)
timeFrame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
measure: Change in Neck and Pain Disability Scale (NPAD)
timeFrame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
measure: Change in Tampa Scale of Kinesiophobia (TSK)
timeFrame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
measure: Change in Active Range of Motion
timeFrame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
measure: Change in Conjunct Motion
timeFrame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
measure: Change in Jerk Movements
timeFrame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
measure: Changes in Joint Position Error (JPE)
timeFrame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
measure: Patient Global Impression of Change (P-GIC)
timeFrame: Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCSS Ospedale San Raffaele
state: MI
Study officials:
References: