Neck Movement Training in a Virtual Reality Headset for People with Neck Pain - a Feasibility Study

NCT06832748 | Not Yet Recruiting

• 2 other identifiers: EPM Dnr 2024-07490-01CIV 24-08-048898
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a virtual reality (VR) intervention for people with chronic neck pain is feasible. The main questions it aims to answer are: Is it possible to perform a future full-scale randomized controlled trial (RCT) with a remotely supervised VR-based intervention for people with chronic neck pain? How do people with neck pain experience using VR in a home-based training intervention? Researchers will investigate if aspects of a full-scale RCT is feasible. This includes how well the recruitment of participants worked, retention during the intervention, compliance to training program, adverse events, and experience using the VR during training. The study will also investigate initial indication of benefit of the VR intervention, such as effects on pain and function. Participants will be randomly assigned to either a VR neck training group or an endurance training group. Both groups will perform a training program for 8 weeks with weekly follow ups with their physiotherapist via online meetings.

Conditions

Neck Pain

Keywords

neck pain; virtual reality; VR; sensorimotor training; pilot RCT; endurance training; whiplash injuries; feasibility studies; randomized controlled trial

Outcome Measures

Primary Outcomes (8)

• Feasibility - Recruitment time (weeks)

  Time taken to recruit 20 participants. This will be measured in number of weeks.

  From enrollment to end of treatment (at 8 weeks)

• Feasibility - Recruitment method

  Which recruitment channels were effective to find participants? (physiotherapy clinics, social media channels, newspaper advertisement, other). This will be measured by asking the participants.

  From enrollment to end of treatment (at 8 weeks)

• Feasibility - Adherence

  Adherence rate to interventions. For the VR training group this is evaluated from the VR online portal training log. For the endurance training group this is evaluated from training diaries. This will be measured by number of completed training sessions and presented as percentage of prescribed dosage. A minimum of 70 % completed training sessions is considered acceptable. Adherence feasibility criteria: ≥ 70% Proceed, 60-69% Proceed with changes, \<60% Do not proceed

  Start of intervention to end of intervention at 8 weeks.

• Feasibility - Completion rate (drop out)

  Number of participants completing the intervention. Intervention completion rate feasibility criteria: ≥ 85% proceed, 70-85% proceed with changes, \<70% do not proceed.

  Start of intervention to end of intervention at 8 weeks.

• Feasibility - Outcome measure completion rate

  Obtained outcome measures from participants completing the intervention. Outcome measure completion rate criteria: ≥ 85% Proceed, 70-85% Proceed with changes, \<70% Do not proceed

  At 8 weeks

• Feasibility - Adverse events

  Number of adverse events and what character. Treating physiotherapists will record any adverse events during the intervention period.

  From start of intervention to 8 weeks

• Feasibility - Numeric Rating Scale (NRS) Simulator sickness intensity

  Sickness intensity measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their sickness intensity right after completion of the test protocol, from no sickness (0) to worst imaginable sickness (10).

  Baseline and at end of intervention (at 8 weeks).

• Feasibility - Participants experience using VR in neck training - Qualitative part

  Participants experience using VR in the 8-week intervention. This information will be obtained from semi-structured interviews, e.g., questions about usability, digitally delivered intervention, video consultations with physiotherapists, information and support, pros and cons of intervention.

  After completion of the 8 weeks VR-intervention, approximately within 2 weeks after completion.

Secondary Outcomes (16)

• Cervical joint position sense (JPS) test (performed in the VR headset)

  Baseline and at end of intervention (at 8 weeks)

• Cervical reaction acuity (CRA) test - Reaction time milliseconds (performed in the VR headset)

  Baseline and at end of intervention (at 8 weeks)

• Cervical reaction acuity (CRA) test - Maximum velocity. (performed in the VR headset)

  Baseline and at end of intervention (at 8 weeks)

• Cervical reaction acuity (CRA) test - Time to complete the task. (performed in the VR headset)

  Baseline and at end of intervention (at 8 weeks)

• Cervical movement sense test (performed in the VR headset)

  Baseline and at end of intervention (at 8 weeks)

Study Arms (2)

VR neck training group (10 participants)

EXPERIMENTAL

10 participants will use a VR headsets and perform training targeting the neck sensorimotor function. The patient interacts through head movements, and perform tasks in the VR environment.

Other: VR neck training

Endurance neck training group (10 participants)

ACTIVE COMPARATOR

10 participants will perform endurance training for the neck and shoulder region, with body weight, rubber bands, and free weights.

Other: Endurance neck training

Interventions

VR neck training OTHER

VR intervention 8 weeks. A VR headset is used for assessment and training of sensorimotor functions of the neck. The VR headset has a built-in sensor which can measure movements and give objective test and training results. The results serve as a guide for tailored home-based training programs, also performed with the VR headset in the experimental group. The participant performs the training at home, 15-20 minutes/day 5 days/week, initiallay divided into 3 sessions of 5 minutes each, while progression may lead to longer but fewer sessions. The program is individually tailored to target specific sensorimotor disturbances, and progressed during the intervention to increase the challenge. Participants will have video consultations with their physiotherapist once a week for the first 4 weeks, and every second week for the final 4 weeks. This can be adjusted to fit the participants needs. The VR is a novel technology, and this particular VR based training is not yet evaluated in research.

VR neck training group (10 participants)

Endurance neck training OTHER

An 8-week traditional endurance neck training intervention. The training program consists of neck and shoulder exercises performed with body weight, rubber bands, and free weights. The training is carried out at home, 15-20 minutes per day, 5 days a week. The training is individualized and progressed during the intervention. Participants will have video consultations with their physiotherapist once a week for the first 4 weeks, and then every second week for the final 4 weeks. This can be adjusted to fit the participants needs. This intervention is often used in the clinic and has been evaluated in several research studies with good results to reduce neck pain. However, its effects on sensorimotor functions have been less evaluated. Also, its effects compared to novel VR-training still needs to be evaluated.

Endurance neck training group (10 participants)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand verbal and written Swedish
• Persistent neck pain (\>3 months)
• Neck pain onset (or acute worsening) in relation to trauma to the head or neck
• Neck disability index 20-60% or Numeric Rating Scale neck pain ≥ 3/10
• Impaired sensorimotor function of the neck (at least one of the sensorimotor tests must be impaired, i.e. below the norm values for the test in question). The following cut-off values are used:
• Joint position sense test: \> 4.5° absolute error in any of the four directions right rotation, left rotation, extension or flexion.
• Movement sense test: \>28 seconds to complete the zigzag pattern, or \<2,5 norm value (i.e., accuracy in percentage divided by time in seconds).
• Maximum velocity from the cervical reaction acuity test: \< 100°/s. Range of motion in right rotation, left rotation, extension and flexion (added together): \< 300°.

You may not qualify if:

• Cervical radiculopathy
• Neck surgery
• Fracture of the neck
• Neurological disease
• Vestibular disease
• Rheumatic disease
• Concussion where the person lost consciousness
• Uncorrected visual impairment
• Epilepsy
• Previous experience of severe symptoms (nausea/dizziness) when using VR headsets

Sponsors & Collaborators

• Luleå Tekniska Universitet: lead

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MeSH Terms

Conditions

Neck Pain; Whiplash Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Ulrik Röijezon, Professor

  Luleå University of Technology. Department of Health, Education and Technology

  STUDY CHAIR

Central Study Contacts

Karin Forsberg, PhD student

CONTACT

+46 920 491358; karin.forsberg@ltu.se

Ulrik Röijezon, Professor

CONTACT

+46 920 492987; ulrik.roijezon@ltu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a feasibility study and pilot randomized controlled trial (RCT). The study will gain knowledge of feasibility of the intervention before a future full scale RCT. The study has a quantitative part to assess the feasibility of the VR-intervention, and to obtain initial measures of possible intervention effects for future sample size calculation when compared to a more traditional rehab intervention. It has also a qualitative part including interviews with the participants in the VR-group.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 18, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share