Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Axial Spondyloarthritis
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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:

1. 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.
2. To assess Proprioception with VR by joiny position error (JPE) test.
3. 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:

1. Spinal ROM and speed of movement, using a motion capture system (mocap)
2. Questionnaires: BASFI, BASMI, BASDAI, TSK, PCS, VAS, and McGill Pain Questionnaire.
3. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 1. Change in spinal mobility
timeFrame: between baseline and one month follow up
measure: Change in movement velocity
timeFrame: Baseline to one month follow up
measure: Change in kinesiophobia
timeFrame: Baseline to one month follow up
measure: Change in pain intensity
timeFrame: Baseline to one month follow up
measure: Changes in Pain severity and location
timeFrame: Baseline to one month follow up
measure: proprioception impairment
timeFrame: from baseline to one month follow up.
measure: Change in spinal flexibility
timeFrame: Baseline to one month follow up
measure: Change in Disease Activity
timeFrame: Baseline to one month follow up
measure: Change in Functional Limitation
timeFrame: from baseline to one month follow up.
measure: Usability of VR rehabilitation
timeFrame: from baseline to one month follow up.
measure: Motion Sickness Symptoms During VR Use
timeFrame: Baseline to one month follow up
measure: Acceptability of VR Rehabilitation
timeFrame: Baseline to one month follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.
citation: Seerden SFL, Dankaerts W, Swinnen TW, Westhovens R, De Vlam K, Vanwanseele B. Axial Spondyloarthritis is associated with changes in lumbosacral loading during daily activities. Clin Biomech (Bristol). 2021 May;85:105347. doi: 10.1016/j.clinbiomech.2021.105347. Epub 2021 Apr 3.
citation: Seerden SFL, Dankaerts W, Swinnen TW, Westhovens R, De Vlam K, Vanwanseele B. Differences in multi-segmental spine kinematics between patients with different stages of axial spondyloarthritis and healthy controls. Musculoskelet Sci Pract. 2021 Jun;53:102368. doi: 10.1016/j.msksp.2021.102368. Epub 2021 Mar 19.
citation: Mouatt, B., Smith, A.E., Mellow, M.L., Parfitt, G., Smith, R.T. and Stanton, T.R., 2020. The use of virtual reality to influence motivation, affect, enjoyment, and engagement during exercise: A scoping review. Frontiers in Virtual Reality, 1, p. 564664.
citation: Ozen T, Tonga E, Polat MG, Bayraktar D, Akar S. Cervical proprioception accuracy is impaired in patients with axial spondyloarthritis. Musculoskelet Sci Pract. 2021 Feb;51:102304. doi: 10.1016/j.msksp.2020.102304. Epub 2020 Nov 16.
citation: Barnett R, Ng S, Sengupta R. Understanding flare in axial spondyloarthritis: novel insights from daily self-reported flare experience. Rheumatol Adv Pract. 2021 Nov 15;5(3):rkab082. doi: 10.1093/rap/rkab082. eCollection 2021.
citation: Aouad K, Gossec L. Defining and managing flares in axial spondyloarthritis. Curr Opin Rheumatol. 2022 Jul 1;34(4):195-202. doi: 10.1097/BOR.0000000000000883. Epub 2022 Jun 9.