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

NCT07527845 | Completed

• 1 other identifier: 220411008
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Low Back Pain; Kinesiophobia (Fear of Movement); Healty Volunteers

Keywords

low back pain; augmented reality; virtual reality; kinesiophobia; proof of concept; pilot study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Peak Angle of Spinal Forward Bending

  During the intervention session (recorded across 10 to 12 repetitions)

• Qualitative Feedback on System Experience and Safety

  Immediately following the intervention session

Study Arms (2)

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

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

Interventions

Augmented Reality (AR) Rehabilitation System DEVICE

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

Also known as: AnReal

Healthy Volunteers (Pilot Phase); Patients with Chronic Low Back Pain (Feasibility Phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Related Publications (7)

• 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.

  PMID: 27428892 BACKGROUND

• 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.

  PMID: 32784745 BACKGROUND

• 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.

  PMID: 38407948 BACKGROUND

• 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.

  PMID: 31746250 BACKGROUND

• 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.

  PMID: 28062380 BACKGROUND

• 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.

  PMID: 30496104 BACKGROUND

• 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.

  PMID: 34542639 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Mauricio Campos, MD

  Pontificia Universidad Catolica de Chile

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: December 1, 2022
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CL (1)