Neck PainNCT03987334
Virtual Reality Rehabilitation in Neck Pain Subjects
A study testing Virtual Reality Treatment in people with Neck Pain and Chronic Pain, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Chronic Pain, Whiplash
- What is being tested?
- Virtual Reality Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2019to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult individuals (18-70 years old);
- Neck Pain (Chronic Neck Pain or Whiplash);
- Normal vision or corrected vision.
Who cannot join
- Informed Consent negation;
- System infection or metabolic/neurological/muscular degenerative disorder;
- Cervical spinal pathology, fracture or surgery;
- Radiculopathy;
- Vestibular impairments;
- Epilepsy;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCSS Ospedale San Raffaele
Milan, MI, 20132
Sandro Iannaccone, 0226435734 ext. 0039, iannaccone.sandro@hsr.it
About this study
Official title: Effects of Virtual Reality Motor Control Rehabilitation in Neck Pain Subjects
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.
Read more
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.
Read the 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.
- Conditions
- Neck Pain, Chronic Pain, Whiplash
- Being tested
- Virtual Reality Treatment, Control Group
- Keywords
- Virtual Reality, Motor Control, Augmented Feedback, Chronic Neck Pain, Whiplash
- Medical subject headings
- Neck Pain, Chronic Pain, Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TreatmentOther
Also called Virtual Reality Motor Control Rehabilitation, Virtual Reality Augmented Feedback, Virtual Reality Rehabilitation System
Experimental Group (VRT) subjects will undergo Virtual Reality Motor Control exercises based on augmented feedback of their performance.
Control GroupOther
Also called Motor Control Rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
Change in Conjunct Motion
Conjunct motion consists in cervical movements in the associated planes relative to the primary movement plane. It may reflect protective postural control strategies.
Measured: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
Change in Jerk Movements
Jerk Movements are the rate of changes in acceleration, a way to quantitatively evaluate smoothness of movements.
Measured: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
Changes in Joint Position Error (JPE)
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°.
Measured: Baseline (at recruitment/before intervention), Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
Patient Global Impression of Change (P-GIC)
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.
Measured: Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start9 May 2019
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Iannaccone, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987334
- Sponsor's protocol ID
- VR-NECKPAIN
- Status last verified
- Feb 2026
- First submitted
- 23 May 2019
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Motor Control Rehabilitation in Neck Pain Subjects
- ClinicalTrials.gov ID
- NCT03987334
- Acronym / sponsor ID
- VR-NECKPAIN
- Conditions
- Neck Pain, Chronic Pain, Whiplash
- Keywords
- Virtual Reality, Motor Control, Augmented Feedback, Chronic Neck Pain, Whiplash
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (VRT) | Experimental | Other: Virtual Reality TreatmentSubjects 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) | Active comparator | Other: Control GroupControl group (CT) subjects will undergo the same treatment of VRT subjects in terms of intensity, time and type, but with the VR turned off. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult individuals (18-70 years old);
- Neck Pain (Chronic Neck Pain or Whiplash);
- Normal vision or corrected vision.
Key exclusion criteria (7 listed)
- Informed Consent negation;
- System infection or metabolic/neurological/muscular degenerative disorder;
- Cervical spinal pathology, fracture or surgery;
- Radiculopathy;
- Vestibular impairments;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality TreatmentAlso: Virtual Reality Motor Control Rehabilitation, Virtual Reality Augmented Feedback, Virtual Reality Rehabilitation SystemExperimental Group (VRT) subjects will undergo Virtual Reality Motor Control exercises based on augmented feedback of their performance. | Other | Experimental Group (VRT) |
| Control GroupAlso: Motor Control RehabilitationControl 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 (CT) |
Primary outcome
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.
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Patient Global Impression of Change (P-GIC)
Time frame: Post-Intervention (after 6 weeks rehabilitation), Follow-Up (after 3 months from completion of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Treatment in people with Neck Pain and Chronic Pain, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandro Iannaccone, Dr (+39 0226435734, iannaccone.sandro@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.