Low Back PainNCT07527845
Feasibility of an Augmented Reality Novel Approach for the Rehabilitation of Chronic Low Back Pain Patients With Kinesiophobia
An observational study of Low Back Pain and Kinesiophobia (Fear of Movement), run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The goal of this clinical trial is to evaluate the feasibility, safety, and initial effectiveness of a new augmented reality (AR) system in adults over 18 years old suffering from chronic low back pain and kinesiophobia (fear of movement). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Kinesiophobia (Fear of Movement), Healty Volunteers
- What is being tested?
- Augmented Reality (AR) Rehabilitation System
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteChile
- Study dates
- 1 Dec 2022to 12 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of two distinct groups recruited for a proof-of-concept and a feasibility trial. The first group includes healthy adult volunteers used for the initial technical validation of the system. The primary clinical group consists of adult patients suffering from non-specific chronic low back pain and kinesiophobia, specifically characterized by a significant limitation in spinal range of motion. All participants were evaluated in a controlled research environment to assess the safety and performance of the AR technology
Who may be able to join
- Participants must be over 18 years old.
- For the pilot phase: Healthy volunteers with no chronic pathologies or musculoskeletal conditions
- For the clinical phase: Diagnosis of non-specific chronic low back pain (CLBP) lasting longer than three months.
- For the clinical phase: Presence of less than 40 degrees of spinal forward bending movement.
Who cannot join
- History of spine surgery.
- Diagnosis of vestibular disorders.
- Diagnosis of Meniere's syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the feasibility, safety, and initial effectiveness of a new augmented reality (AR) system in adults over 18 years old suffering from chronic low back pain and kinesiophobia (fear of movement).
The main questions it aims to answer are:
Read more
Is the AR system safe to use and well-tolerated by participants without causing significant motion sickness or discomfort?
Can the visual "illusion" provided by the AR technology help patients increase their range of motion and reduce their fear of bending forward?
Participants will:
- Perform 10 to 12 repetitions of spinal bending exercises while wearing an AR headset that shows a video of them moving further than they actually are.
- Complete questionnaires regarding their pain levels, physical disability, and fear of movement.
- Report any symptoms of "cybersickness" (like dizziness or nausea) experienced during the use of the technology.
- Participate in a brief interview to discuss their experience, how they felt using the device, and provide suggestions for improvement.
Read the detailed description
Background and Scientific Rationale Chronic low back pain (CLBP) is frequently associated with kinesiophobia, an irrational and debilitating fear of physical movement rooted in the anticipation of pain. This fear often leads to avoidance behaviors, which further limit functional recovery and perpetuate disability. While traditional physical therapy is the standard of care, it often struggles to bypass these psychological barriers. This study explores the use of "AnReal," a novel rehabilitation system that integrates augmented reality (AR) and computer vision to facilitate movement through sensory recalibration.
The AnReal Technology The intervention utilizes an Android-based mobile application paired with a low-cost virtual reality headset. The system employs computer vision algorithms to track the patient's spinal flexion in real-time. The core technical innovation is a visual feedback loop: as the patient performs a forward bending motion, the AR interface generates a visual illusion-via a synchronized video-showing the patient's body continuing the movement beyond their actual physical limit.
Study Procedures
Healthy participants and low back pain patients undergo a session consisting of 10 to 12 repetitions of spinal forward bending guided by the AnReal system. During each repetition, the technology tracks the peak angle of flexion and provides real-time visual cues to encourage progress. Following the physical task, a mixed-methods approach is used to evaluate the experience:
- Quantitative Assessment: Evaluation of cybersickness symptoms and user experience scores.
- Qualitative Assessment: Semi-structured interviews to capture perceptions of safety, movement harmony, and the convincing nature of the visual illusion.
This pilot trial focuses on establishing the feasibility and safety of this task-specific AR tool as a potential complement to traditional physical therapy
- Being tested
- Augmented Reality (AR) Rehabilitation System
- Keywords
- low back pain, augmented reality, virtual reality, kinesiophobia, proof of concept, pilot study
- Medical subject headings
- Low Back Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality (AR) Rehabilitation SystemDevice
Also called AnReal
System Components: An Android-based mobile application used in conjunction with a low-cost virtual reality (VR) headset.
Technical Core: The system integrates computer vision algorithms and artificial intelligence to track and analyze spinal forward bending in real-time.
Visual Feedback Loop: It creates a visual illusion of continued movement, showing the patient's body performing a greater range of motion than they are actually executing.
Mechanism: This task-specific intervention uses visual cues and graded exposure to reduce fear of movement (kinesiophobia) and encourage a greater range of motion in patients with chronic low back pain
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers (Pilot Phase) | Description: A group of healthy volunteers (n=7) over 18 years old with no chronic pathologies or musculoskeletal conditions Role: This group was used for the initial testing and iterative development of the AnReal system to evaluate user experience and baseline cybersickness. Feedback from this group led to technical modifications of the software before testing it with the clinical population Receives: Device: Augmented Reality (AR) Rehabilitation System | |
| Patients with Chronic Low Back Pain (Feasibility Phase) | Description: A group of patients (n=10) over 18 years old diagnosed with non-specific chronic low back pain for more than three months, presenting with kinesiophobia and limited range of motion (less than 40 degrees of spinal forward bending).
Role: This is the primary clinical cohort used to evaluate the feasibility, safety, and potential impact of the AR-based intervention on pain-related fear and physical movement Receives: Device: Augmented Reality (AR) Rehabilitation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulator Sickness Questionnaire (SSQ)
A standardized questionnaire used to evaluate symptoms of cybersickness (dizziness, nausea, etc.) associated with the use of the AR headset. It measures 16 symptoms across three subscores: Nausea, Oculomotor, and Disorientation. The total score represents the overall severity of the symptoms.
Measured: Immediately after the technology testing session (single assessment)
Secondary outcomes (2)
Peak Angle of Spinal Forward Bending
The maximum angle of spinal flexion (in degrees) achieved by the participant while using the AR device. This measures the physical response to the visual feedback provided by the system.
Measured: During the intervention session (recorded across 10 to 12 repetitions)
Qualitative Feedback on System Experience and Safety
Data collected through semi-structured interviews regarding the participants' perception of safety, the harmony of the movement, and their motivation to move further.
Measured: Immediately following the intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Dec 2022
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
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 Low Back PainStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauricio Campos, MD, Study chair, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527845
- Sponsor's protocol ID
- 220411008
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The small sample size of this pilot study and the qualitative nature of part of the data make it difficult to share de-identified data while fully ensuring participant privacy.
Publications
Vlaeyen JWS, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 2016 Aug;157(8):1588-1589. doi: 10.1097/j.pain.0000000000000574. No abstract available.
PubMed 27428892Berton A, Longo UG, Candela V, Fioravanti S, Giannone L, Arcangeli V, Alciati V, Berton C, Facchinetti G, Marchetti A, Schena E, De Marinis MG, Denaro V. Virtual Reality, Augmented Reality, Gamification, and Telerehabilitation: Psychological Impact on Orthopedic Patients' Rehabilitation. J Clin Med. 2020 Aug 7;9(8):2567. doi: 10.3390/jcm9082567.
PubMed 32784745Li R, Li Y, Kong Y, Li H, Hu D, Fu C, Wei Q. Virtual Reality-Based Training in Chronic Low Back Pain: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2024 Feb 26;26:e45406. doi: 10.2196/45406.
PubMed 38407948Tack C. Virtual reality and chronic low back pain. Disabil Rehabil Assist Technol. 2021 Aug;16(6):637-645. doi: 10.1080/17483107.2019.1688399. Epub 2019 Nov 20.
PubMed 31746250Perrot S, Trouvin AP, Rondeau V, Chartier I, Arnaud R, Milon JY, Pouchain D. Kinesiophobia and physical therapy-related pain in musculoskeletal pain: A national multicenter cohort study on patients and their general physicians. Joint Bone Spine. 2018 Jan;85(1):101-107. doi: 10.1016/j.jbspin.2016.12.014. Epub 2017 Jan 3.
PubMed 28062380GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.
PubMed 34542639
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Augmented Reality Novel Approach for the Rehabilitation of Chronic Low Back Pain Patients With Kinesiophobia
- ClinicalTrials.gov ID
- NCT07527845
- Acronym / sponsor ID
- 220411008
- Keywords
- low back pain, augmented reality, virtual reality, kinesiophobia, proof of concept, pilot study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 14 Apr 2026 (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.
The goal of this clinical trial is to evaluate the feasibility, safety, and initial effectiveness of a new augmented reality (AR) system in adults over 18 years old suffering from chronic low back pain and kinesiophobia (fear of movement).
The main questions it aims to answer are:
Is the AR system safe to use and well-tolerated by participants without causing significant motion sickness or discomfort?
Can the visual "illusion" provided by the AR technology help patients increase their range of motion and reduce their fear of bending forward?
Participants will:
- Perform 10 to 12 repetitions of spinal bending exercises while wearing an AR headset that shows a video of them moving further than they actually are.
- Complete questionnaires regarding their pain levels, physical disability, and fear of movement.
- Report any symptoms of "cybersickness" (like dizziness or nausea) experienced during the use of the technology.
- Participate in a brief interview to discuss their experience, how they felt using the device, and provide suggestions for improvement.
Detailed description
Background and Scientific Rationale Chronic low back pain (CLBP) is frequently associated with kinesiophobia, an irrational and debilitating fear of physical movement rooted in the anticipation of pain. This fear often leads to avoidance behaviors, which further limit functional recovery and perpetuate disability. While traditional physical therapy is the standard of care, it often struggles to bypass these psychological barriers. This study explores the use of "AnReal," a novel rehabilitation system that integrates augmented reality (AR) and computer vision to facilitate movement through sensory recalibration.
The AnReal Technology The intervention utilizes an Android-based mobile application paired with a low-cost virtual reality headset. The system employs computer vision algorithms to track the patient's spinal flexion in real-time. The core technical innovation is a visual feedback loop: as the patient performs a forward bending motion, the AR interface generates a visual illusion-via a synchronized video-showing the patient's body continuing the movement beyond their actual physical limit.
Study Procedures
Healthy participants and low back pain patients undergo a session consisting of 10 to 12 repetitions of spinal forward bending guided by the AnReal system. During each repetition, the technology tracks the peak angle of flexion and provides real-time visual cues to encourage progress. Following the physical task, a mixed-methods approach is used to evaluate the experience:
- Quantitative Assessment: Evaluation of cybersickness symptoms and user experience scores.
- Qualitative Assessment: Semi-structured interviews to capture perceptions of safety, movement harmony, and the convincing nature of the visual illusion.
This pilot trial focuses on establishing the feasibility and safety of this task-specific AR tool as a potential complement to traditional physical therapy
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers (Pilot Phase) | – | Device: Augmented Reality (AR) Rehabilitation SystemDescription: A group of healthy volunteers (n=7) over 18 years old with no chronic pathologies or musculoskeletal conditions Role: This group was used for the initial testing and iterative development of the AnReal system to evaluate user experience and baseline cybersickness. Feedback from this group led to technical modifications of the software before testing it with the clinical population |
| Patients with Chronic Low Back Pain (Feasibility Phase) | – | Device: Augmented Reality (AR) Rehabilitation SystemDescription: A group of patients (n=10) over 18 years old diagnosed with non-specific chronic low back pain for more than three months, presenting with kinesiophobia and limited range of motion (less than 40 degrees of spinal forward bending). Role: This is the primary clinical cohort used to evaluate the feasibility, safety, and potential impact of the AR-based intervention on pain-related fear and physical movement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of two distinct groups recruited for a proof-of-concept and a feasibility trial. The first group includes healthy adult volunteers used for the initial technical validation of the system. The primary clinical group consists of adult patients suffering from non-specific chronic low back pain and kinesiophobia, specifically characterized by a significant limitation in spinal range of motion. All participants were evaluated in a controlled research environment to assess the safety and performance of the AR technology
Key inclusion criteria (4 listed)
- Participants must be over 18 years old.
- For the pilot phase: Healthy volunteers with no chronic pathologies or musculoskeletal conditions
- For the clinical phase: Diagnosis of non-specific chronic low back pain (CLBP) lasting longer than three months.
- For the clinical phase: Presence of less than 40 degrees of spinal forward bending movement.
Key exclusion criteria (3 listed)
- History of spine surgery.
- Diagnosis of vestibular disorders.
- Diagnosis of Meniere's syndrome
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 |
|---|---|---|
| Augmented Reality (AR) Rehabilitation SystemAlso: AnRealSystem Components: An Android-based mobile application used in conjunction with a low-cost virtual reality (VR) headset. Technical Core: The system integrates computer vision algorithms and artificial intelligence to track and analyze spinal forward bending in real-time. Visual Feedback Loop: It creates a visual illusion of continued movement, showing the patient's body performing a greater range of motion than they are actually executing. Mechanism: This task-specific intervention uses visual cues and graded exposure to reduce fear of movement (kinesiophobia) and encourage a greater range of motion in patients with chronic low back pain | Device | Healthy Volunteers (Pilot Phase), Patients with Chronic Low Back Pain (Feasibility Phase) |
Primary outcome
Simulator Sickness Questionnaire (SSQ)
Time frame: Immediately after the technology testing session (single assessment)
A standardized questionnaire used to evaluate symptoms of cybersickness (dizziness, nausea, etc.) associated with the use of the AR headset. It measures 16 symptoms across three subscores: Nausea, Oculomotor, and Disorientation. The total score represents the overall severity of the symptoms.
2 secondary outcomes
Peak Angle of Spinal Forward Bending
Time frame: During the intervention session (recorded across 10 to 12 repetitions)
Qualitative Feedback on System Experience and Safety
Time frame: Immediately following the intervention session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 27428892Vlaeyen JWS, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 2016 Aug;157(8):1588-1589. doi: 10.1097/j.pain.0000000000000574. No abstract available.
- Background: PubMed 32784745Berton A, Longo UG, Candela V, Fioravanti S, Giannone L, Arcangeli V, Alciati V, Berton C, Facchinetti G, Marchetti A, Schena E, De Marinis MG, Denaro V. Virtual Reality, Augmented Reality, Gamification, and Telerehabilitation: Psychological Impact on Orthopedic Patients' Rehabilitation. J Clin Med. 2020 Aug 7;9(8):2567. doi: 10.3390/jcm9082567.
- Background: PubMed 38407948Li R, Li Y, Kong Y, Li H, Hu D, Fu C, Wei Q. Virtual Reality-Based Training in Chronic Low Back Pain: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2024 Feb 26;26:e45406. doi: 10.2196/45406.
- Background: PubMed 31746250Tack C. Virtual reality and chronic low back pain. Disabil Rehabil Assist Technol. 2021 Aug;16(6):637-645. doi: 10.1080/17483107.2019.1688399. Epub 2019 Nov 20.
- Background: PubMed 28062380Perrot S, Trouvin AP, Rondeau V, Chartier I, Arnaud R, Milon JY, Pouchain D. Kinesiophobia and physical therapy-related pain in musculoskeletal pain: A national multicenter cohort study on patients and their general physicians. Joint Bone Spine. 2018 Jan;85(1):101-107. doi: 10.1016/j.jbspin.2016.12.014. Epub 2017 Jan 3.
- Background: PubMed 30496104GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Background: PubMed 34542639Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.
- Individual participant dataSharing planned: Undecided. The small sample size of this pilot study and the qualitative nature of part of the data make it difficult to share de-identified data while fully ensuring participant privacy.
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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. This study is not recruiting at the moment.
Mauricio Campos, MD study chair
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Kinesiophobia (Fear of Movement), run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 4 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: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulator Sickness Questionnaire (SSQ) (time frame: Immediately after the technology testing session (single assessment)). 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 NCT07527845, 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 14 Apr 2026.