Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06967077

Exploring the Feasibility and Acceptability of Virtual Reality Exercise for Pain Management, Fear of Movement, Mobility, and Proprioception Deficit in Axial Spondyloarthritis Patients During Flares: Twics Design

Axial spondyloarthritis (axSpA) is an autoimmune disease that causes inflammatory arthritis of the spine, causing pain, stiffness, and mobility limitations. During flares, when symptoms worsen, people with axSpA often experience increased pain and difficulty moving, making daily activities more challenging. This study aims to explore whether virtual reality (VR) exercise can help manage pain, improve movement, and support rehabilitation for axSpA patients during flares.

Participants will use a VR system to perform gentle exercises designed to encourage movement and reduce discomfort. Their spinal mobility will be measured using motion capture technology, and their experiences with VR will be assessed through questionnaires and interviews.

This research will help determine whether VR can be a practical and beneficial tool for axSpA rehabilitation, potentially offering a new way to manage symptoms and improve quality of life. The findings will guide future studies on using VR in healthcare settings for people with chronic pain conditions.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting the spine and sacroiliac joints, causing pain, stiffness, and reduced mobility. Flares are periods of increased disease activity, which significantly impact patients' ability to move and perform daily tasks, often accompanied by heightened levels of pain and fear of movement, known as kinesiophobia., leading to long-term reductions in mobility and quality of life. Although physical activity is recognized as a valuable self-management tool, some axSpA patients report discomfort or joint injury during exercise, limiting their physical performance.

Additionally, proprioception is often impaired in inflammatory joint diseases, including axSpA. However, proprioception is poorly investigated in axSpA patients. There is a need to better understand mobility and proprioception during and after flares, as this could provide valuable insights for alleviating pain and enhancing functional mobility.

VR systems have shown promise in managing chronic pain and improving physical function through distraction and engaging virtual games. but its feasibility for axSpA patients remains understudied.

Aim:

Evaluate the feasibility of using VR exercises for axSpA patients during flare periods, for pain management, kinesiophobia, mobility improvement, and proprioception impairment.

Objectives:

  • To examine the impact of virtual reality (VR) training on reducing kinesiophobia, managing pain, and improving disease activity by analysing the correlation between range of motion (ROM) and velocity during VR training and the Tampa Scale of Kinesiophobia (TSK), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Visual Analogue Scale (VAS), and McGill Pain Questionnaire.
  • To assess Proprioception with VR by joiny position error (JPE) test.
  • To evaluate the feasibility of using VR for axSpA rehabilitation by assessing usability and acceptability through interviews and questionnaires, including virtual reality sickness questionnaires and technology acceptance models (TAM).

This study will employ the Trials within Cohort (TwiCs), which facilitates running an RCT by recruiting one control group for biomechanical and virtual reality assessments. From this group, eligible patients will be randomly selected to join the intervention arm, which involves a VR exercise intervention.

All cohort participants will provide initial consent for the use of their observational data as controls. If selected for the intervention, additional consent will be obtained. Those allocated as controls will not need further consent and will continue with standard assessments.

Participants chosen for the intervention will receive an updated participant information sheet and will sign an additional consent form specific to the intervention.

All participants will attend four sessions: one at baseline, one during flare, one after flare, and one month post-flare.

Session 1 (Baseline Assessment): Participants will undergo baseline assessments which includes:

  • Spinal ROM and speed of movement, using a motion capture system (mocap)
  • Questionnaires: BASFI, BASMI, BASDAI, TSK, PCS, VAS, and McGill Pain Questionnaire.
  • JPE Testing: Proprioception will be assessed using VR system by targeting specific joint positions 10 times based on each participant's full ROM. participants will be randomly assigned to either the intervention group (VR) or the control group. Those in the intervention group will be informed of their eligibility and provided with an information sheet and consent form specific to the VR intervention. A demonstration of how to use the VR tennis game will be provided to ensure familiarity with the system.

Session 2 (During a Flare): All participants will complete the same assessments as in Session 1, with the intervention group additionally performing the VR tennis game followed by feasibility assessment including usability and acceptability assessment of the VR intervention using both questionnaires and interviews.

If a participant from the intervention group is unable to attend due to a severe flare, a VR headset will be delivered to their home along with a video tutorial to remind them of the previously demonstrated process. Both groups will complete BASDAI questionnaire daily using a link to Microsoft forms platform.

Session 3 (Post-Flare Assessment): Post-flare assessments will be conducted, including a repeat of baseline measures for both groups, and collection of participant feedback on the VR intervention through questionnaires and interviews for the intervention group..

Session 4 (One-Month Follow-up): A one-month follow-up assessment will be conducted repeating the assessment from first session for both groups.

Session 2 (During a Flare): All participants will complete the same assessments as in Session 1, with the intervention group additionally performing the VR tennis game. If a participant from the intervention group is unable to attend due to a severe flare, a VR headset will be delivered to their home along with a video tutorial to remind them of the previously demonstrated process. Both groups will complete BASDAI questionnaire daily using a link to Microsoft forms platform.

Session 3 (Post-Flare Assessment): Post-flare assessments will be conducted, including a repeat of baseline measures and the collection of participant feedback on VR usability.

Session 4 (One-Month Follow-up): A one-month follow-up assessment will be conducted to reassess mobility, pain, and proprioception outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of axial spondyloarthritis (axSpA).
  • Experiencing an active flare of axSpA within the last 6 months
  • Over 18 years of age.

Exclusion criteria

  • History of major spinal surgery.
  • Pregnancy.
  • Severe vestibular disorders, visual, balance, neurological, or cardiovascular conditions that may affect mobility.

Treatment and study plan

Virtual reality head set.

Other

Tennis game exercise using virtual reality head set

Primary outcomes

  1. 1. Change in spinal mobility

    Time frame: between baseline and one month follow up

    Spinal mobility will be assessed using range of motion (ROM) measured via motion capture system.

  2. Change in movement velocity

    Time frame: Baseline to one month follow up

    Movement velocity of spinal flexion, extension, and rotation will be measured using a motion capture system. Peak angular velocity (degrees/second) will be recorded during standardised movement tasks and compared between baseline and one-month follow-up.

    Unit of Measure: Degrees/second

  3. Change in kinesiophobia

    Time frame: Baseline to one month follow up

    Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK). The scale ranges from 17 to 68, with higher scores indicating greater fear of movement.

    Unit of Measure: TSK score (17-68; higher = worse)

  4. Change in pain intensity

    Time frame: Baseline to one month follow up

    Pain intensity will be assessed using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, with higher scores indicating greater pain. Change from baseline to follow-up will be analysed.

    Unit of Measure: VAS score (0-10; higher = worse)

  5. Changes in Pain severity and location

    Time frame: Baseline to one month follow up

    Pain severity and location will be assessed using the McGill Pain Questionnaire Short Form (MPQ-SF). The scale ranges from 0 to 78, with higher scores indicating greater pain severity.

    Unit of Measure: MPQ-SF score (0-78; higher = worse)

  6. proprioception impairment

    Time frame: from baseline to one month follow up.

    Changes in JPE scores between flare and non-flare stages to determine proprioception impairments

    Joint Position Error (JPE) will be measured using a spine movement reposition task by asking participants to duplicate angle of movement (for example 45 degree of spine flexion) to assess spine proprioception. Higher JPE scores reflect greater proprioceptive impairment.

    Unit of Measure: Degrees of deviation from target position Scale Range: 0-180 degrees (theoretically depends on direction of movement); lower scores indicate better proprioception

  7. Change in spinal flexibility

    Time frame: Baseline to one month follow up

    Spinal flexibility will be measured using the Bath Ankylosing Spondylitis Metrology Index (BASMI). The scale ranges from 0 to 10, with higher scores indicating worse spinal mobility.

    Unit of Measure: BASMI score (0-10; higher = worse)

  8. Change in Disease Activity

    Time frame: Baseline to one month follow up

    Improvement in disease activity assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  9. Change in Functional Limitation

    Time frame: from baseline to one month follow up.

    Improvement in functional limitation as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) and its correlation with objective movement parameters.

    BASFI (0-10 scale): Higher scores indicate worse functional limitation.

  10. Usability of VR rehabilitation

    Time frame: from baseline to one month follow up.

    Usability will be assessed using the System Usability Scale (SUS).

    SUS: A 10-item scale with scores ranging from 0 to 100. Higher scores indicate better usability.

    Unit of Measure: SUS score (0-100)

  11. Motion Sickness Symptoms During VR Use

    Time frame: Baseline to one month follow up

    motion sickness, will be assessed using the Virtual Reality Sickness Questionnaire (VRSQ).

    VRSQ: Includes multiple subscales measuring symptoms such as oculomotor strain and disorientation.

    Higher scores indicate greater motion sickness symptoms.

    Unit of Measure: VRSQ subscale scores

  12. Acceptability of VR Rehabilitation

    Time frame: Baseline to one month follow up

    Acceptability will be assessed through semi-structured interviews exploring participants' experiences, perceived benefits, barriers to use, and overall views on the intervention.

    Unit of Measure: Qualitative themes derived from participant interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Dario Cazzola, Dr

CONTACT

[email protected]

+44 (0)1225 388388

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.