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.

Study Overview

• Status: Not yet recruiting
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Other: Virtual reality head set.

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dario Cazzola, Dr; Phone Number: +44 (0)1225 388388; Email: dc547@bath.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; 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.
Experimental: Virtual reality group; 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. additionally they will be performing the VR tennis game for 10 minutes daily during flare stage. followed by feasibility assessment including usability and acceptability assessment of the VR intervention using both questionnaires and interviews during second and third sessions.	Other: Virtual reality head set.; Tennis game exercise using virtual reality head set

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Change in spinal mobility	Spinal mobility will be assessed using range of motion (ROM) measured via motion capture system.	between baseline and one month follow up
Change in movement velocity	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	Baseline to one month follow up
Change in kinesiophobia	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)	Baseline to one month follow up
Change in pain intensity	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)	Baseline to one month follow up
Changes in Pain severity and location	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)	Baseline to one month follow up
proprioception impairment	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	from baseline to one month follow up.
Change in spinal flexibility	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)	Baseline to one month follow up
Change in Disease Activity	Improvement in disease activity assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Baseline to one month follow up
Change in Functional Limitation	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.	from baseline to one month follow up.
Usability of VR rehabilitation	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)	from baseline to one month follow up.
Motion Sickness Symptoms During VR Use	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	Baseline to one month follow up
Acceptability of VR Rehabilitation	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	Baseline to one month follow up

Collaborators and Investigators

• Sponsor: University of Bath

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 10, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: May 7, 2025
• First Posted (Actual): May 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis
• Other Study ID Numbers: 5485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD), including movement analysis, pain scores, and patient-reported outcomes, will be shared exclusively with my PhD supervisors for internal review and guidance. No public access or external data requests will be permitted. Personal identifiers will be removed to maintain confidentiality
• IPD Sharing Time Frame: Data will be made available to supervisors during the study period and up to one year after completion for internal review and analysis
• IPD Sharing Access Criteria: Access is restricted to my PhD supervisors for internal study review. No external sharing will be permitted. The data will be handled in accordance with institutional and ethical guidelines
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No