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Virtual Reality Rehabilitation in Neck Pain Subjects

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ClinicalTrials.gov Identifier: NCT03987334
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sandro Iannaccone, IRCCS San Raffaele

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.


Condition or disease Intervention/treatment Phase
Neck Pain Chronic Pain Whiplash Other: Virtual Reality Treatment Other: Control Group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Virtual Reality Motor Control Rehabilitation in Neck Pain Subjects
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group (VRT)
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
Experimental Group (VRT) subjects will undergo Virtual Reality Motor Control exercises based on augmented feedback of their performance.
Other Names:
  • Virtual Reality Motor Control Rehabilitation
  • Virtual Reality Augmented Feedback
  • Virtual Reality Rehabilitation System

Active Comparator: Control Group (CT)
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
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 Name: Motor Control Rehabilitation




Primary Outcome Measures :
  1. Change in Neck Disability Index (NDI) [ Time Frame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    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.


Secondary Outcome Measures :
  1. Change in Numeric Rating Scale (NRS) [ Time Frame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    The Numeric Rating Scale is a segmented numeric horizontal bar on which patients select a whole number (from 0 "no pain" to 10 "worst possible pain") that best reflects the intensity of their pain at rest and on movement. It has become a widely used instrument for pain screening and is ubiquitous as a screener in many health care environments.

  2. Change in Neck and Pain Disability Scale (NPAD) [ Time Frame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    The Neck and Pain Disability Scale is made by a 20 items measuring the intensity of pain and its interference with vocational, recreational, social and functional aspects of living and the presence and extent of associated emotional factors. Patients respond to each item by marking along a 10-cm visual analog scale. Item scores range from 0 to 5.

  3. Change in Tampa Scale of Kinesiophobia (TSK) [ Time Frame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    The Tampa Scale of Kinesiophobia is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The original questionnaire was developed to "discriminate between non-excessive fear and phobia among patients with chronic musculoskeletal pain". The scale was then found to be valid and reliable. Initially it was used in order to assess fear of movement related to chronic low back pain, but then it has been used for pain related to different parts of the body, including the cervical spine. The TSK is a self-completed questionnaire and the range of scores are from 17 to 68, where the higher scores indicate an increasing kinesiophobia.

  4. Change in Active Range of Motion [ Time Frame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    The distance and direction to which a bone joint can be extended. Range of motion is a function of the condition of the joints, muscles, and connective tissues involved.

  5. Change in Conjunct Motion [ Time Frame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    Conjunct motion consists in cervical movements in the associated planes relative to the primary movement plane. It may reflect protective postural control strategies.

  6. Change in Jerk Movements [ Time Frame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    Jerk Movements are the rate of changes in acceleration, a way to quantitatively evaluate smoothness of movements.

  7. Changes in Joint Position Error (JPE) [ Time Frame: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    The JPE will be recorded as the difference in head orientation between the start position (positioned vertically by a physiotherapist) and the position after a target catching in a 8 different circle-direction with movements of 20°.

  8. Patient Global Impression of Change (P-GIC) [ Time Frame: Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention) ]
    The Patient Global Impression of Change scale is recommended for use in chronic pain clinical trials as a core outcome measure of global improvement with treatment. The scale measures the change in patient's overall status since the beginning of the study on a scale of: 1 (very much improved); 2 (much improved); 3 (minimally improved); 4 (no change); 5 (minimally worse); 6 (much worse); and 7 (very much worse). This measure is a single-item rating by participants of their improvement with treatment during a clinical trial on a 7-point scale that ranges from 'very much improved' to 'very much worse' with 'no change' as the mid-point. The data provide a responsive and readily interpretable measure of participants' assessments of the clinical importance of their improvement or worsening over the course of a clinical trial.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987334


Contacts
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Contact: Sandro Iannaccone, Dr +39 0226435734 iannaccone.sandro@hsr.it

Locations
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Italy
IRCSS Ospedale San Raffaele Recruiting
Milan, MI, Italy, 20132
Contact: Sandro Iannaccone    0226435734 ext 0039    iannaccone.sandro@hsr.it   
Sponsors and Collaborators
IRCCS San Raffaele

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Responsible Party: Sandro Iannaccone, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03987334     History of Changes
Other Study ID Numbers: VR-NECKPAIN
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandro Iannaccone, IRCCS San Raffaele:
Virtual Reality
Motor Control
Augmented Feedback
Chronic Neck Pain
Whiplash

Additional relevant MeSH terms:
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Chronic Pain
Neck Pain
Whiplash Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Neck Injuries
Wounds and Injuries