Feasibility of an Augmented Reality Novel Approach for the Rehabilitation of Chronic Low Back Pain Patients With Kinesiophobia

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Healty Volunteers; Kinesiophobia (Fear of Movement)
• Intervention / Treatment: Device: Augmented Reality (AR) Rehabilitation System

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Pontificia Universidad Católica de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• History of spine surgery.
• Diagnosis of vestibular disorders.
• Diagnosis of Meniere's syndrome

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Augmented Reality (AR) Rehabilitation System; 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; Other Names: AnReal
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	Device: Augmented Reality (AR) Rehabilitation System; 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; Other Names: AnReal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the technology testing session (single assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Immediately following the intervention session

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Investigators: Study Chair: Mauricio Campos, MD, Pontificia Universidad Católica de Chile

Publications and helpful links

General 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.
• Berton 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.
• Tack 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.
• Arjomandi 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.
• GBD 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.
• Li 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.
• Perrot 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: low back pain; augmented reality; pilot study; virtual reality; kinesiophobia; proof of concept
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Back Pain; Phobic Disorders; Anxiety Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Kinesiophobia; Low Back Pain
• Other Study ID Numbers: 220411008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No