Axial SpondyloarthritisNCT06967077
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
A study testing Virtual reality head set. in people with Axial Spondyloarthritis, run by University of Bath.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Virtual reality head set.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 10 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of axial spondyloarthritis (axSpA).
- Experiencing an active flare of axSpA within the last 6 months
- Over 18 years of age.
Who cannot join
- History of major spinal surgery.
- Pregnancy.
- Severe vestibular disorders, visual, balance, neurological, or cardiovascular conditions that may affect mobility.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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:
- 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.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Virtual reality head set.
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality head set.Other
Tennis game exercise using virtual reality head set
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual reality head set. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in spinal mobility
Spinal mobility will be assessed using range of motion (ROM) measured via motion capture system.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline to one month follow up
Change in Disease Activity
Improvement in disease activity assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline to one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Jamil Kattan, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967077
- Sponsor's protocol ID
- 5485
- Status last verified
- May 2025
- First submitted
- 26 Mar 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 11587113Seerden 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.
PubMed 33905963Seerden 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.
PubMed 33780698Mouatt, 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.
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.
PubMed 33227676Barnett 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.
PubMed 34926981Aouad 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.
PubMed 35699318
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06967077
- Acronym / sponsor ID
- 5485
- Conditions
- Axial Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Virtual reality head set.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of axial spondyloarthritis (axSpA).
- Experiencing an active flare of axSpA within the last 6 months
- Over 18 years of age.
Key exclusion criteria (3 listed)
- History of major spinal surgery.
- Pregnancy.
- Severe vestibular disorders, visual, balance, neurological, or cardiovascular conditions that may affect mobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality head set.Tennis game exercise using virtual reality head set | Other | Virtual reality group |
Primary outcome
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.
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
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)
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)
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)
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
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)
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)
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.
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)
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 11587113Hoffman 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.
- Background: PubMed 33905963Seerden 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.
- Background: PubMed 33780698Seerden 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.
- BackgroundMouatt, 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: PubMed 33227676Ozen 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.
- Background: PubMed 34926981Barnett 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.
- Background: PubMed 35699318Aouad 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.
- Individual participant dataSharing planned: Yes. 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
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Recruiting
RENEW Intervention for Axial Spondyloarthritis
Axial Spondyloarthritis
RecruitingObservational study
Natural History and Development of Spondyloarthritis
Arthritis, Spondylitis, Ankylosing
Not yet recruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality head set. in people with Axial Spondyloarthritis, run by University of Bath.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dario Cazzola, Dr (+44 (0)1225 388388, dc547@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Change in spinal mobility (time frame: between baseline and one month follow up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06967077, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.