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

NCT06967077 | Not Yet Recruiting

• 1 other identifier: 5485
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

control group

NO INTERVENTION

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.

Virtual reality group

EXPERIMENTAL

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. 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.

Interventions

Virtual reality head set. OTHER

Tennis game exercise using virtual reality head set

Virtual reality group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bath: lead

Related Publications (7)

• 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.

  PMID: 11587113 BACKGROUND

• 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.

  PMID: 33905963 BACKGROUND

• 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.

  PMID: 33780698 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33227676 BACKGROUND

• 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.

  PMID: 34926981 BACKGROUND

• 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.

  PMID: 35699318 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

Dario Cazzola, Dr

CONTACT

+44 (0)1225 388388; dc547@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PhD student)

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: May 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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
• 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