NCT07492784

Brief Summary

This study investigates the effects of a 4-week virtual reality (VR)-based back school program on pain, disability, fear of movement, and lumbar joint position sense (JPS) in individuals with chronic low back pain. Thirty-nine participants are allocated to either a VR-based back school group or a conventional back school group. Both groups perform supervised low back exercises. Pain, disability, proprioception, kinesiophobia, and perceived cognitive deficits are assessed before and after the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 14, 2026

Last Update Submit

March 19, 2026

Conditions

Chronic Back and Leg Pain

Keywords

Back schoolexercisepainphysiotherapyvirtual reality

Outcome Measures

Primary Outcomes (5)

  • Pain intensity

    Pain intensity was evaluated using a 10-cm VAS developed by Price et al. In this scale, the starting point is defined as "0 = no pain" and the end point as "10 = unbearable pain." Participants were asked to mark their current pain levels on this line. Pain levels were assessed separately at rest, during activity, and at night.

    At baseline and immediately post-intervention (4 weeks)

  • Lumbar joint position sense

    Lumbar joint position sense (JPS) was evaluated using a goniometric measurement method. Participants were comfortably positioned, and the assessor passively moved their lumbar spine into a specific angle of flexion or extension. After holding the target angle for 3 seconds to allow proprioceptive encoding, participants were asked to actively replicate the position. The absolute error between the passively given angle and the actively replicated angle was recorded in degrees.

    At baseline and immediately post-intervention (4 weeks)

  • Tampa Scale for Kinesiophobia

    Fear of movement was assessed using the Turkish version of the Tampa Scale for Kinesiophobia (TSK). This 17-item questionnaire utilizes a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree) to evaluate kinesiophobia and movement avoidance following an injury. After reverse-scoring items 4, 8, 12, and 16, a total score ranging from 17 to 68 is calculated, with higher scores indicating greater kinesiophobia.

    At baseline and immediately post-intervention (4 weeks)

  • Functional disability

    Functional disability was measured with the Oswestry Disability Index (ODI). The ODI consists of 10 sections related to daily living activities such as personal care, lifting, walking, sitting, standing, and sleeping. Each section is scored from 0 to 5. The total score ranges from 0 to 50, categorized as no disability (0-4), mild (5-14), moderate (15-24), severe (25-34), and complete disability (35-50).

    At baseline and immediately post-intervention (4 weeks)

  • Perceived Deficits Questionnaire

    Subjective cognitive function was evaluated using the Perceived Deficits Questionnaire (PDQ) developed by Sullivan et al. This 20-item scale assesses different domains of cognitive function, including attention/concentration, retrospective memory, prospective memory, and planning/organization. It is scored on a 5-point Likert-type scale (0 = never, 4 = almost always). Total scores range from 0 to 80, with higher scores reflecting greater perceived cognitive impairment over the past four weeks.

    At baseline and immediately post-intervention (4 weeks)

Study Arms (5)

Pain intensity

EXPERIMENTAL

In this scale, the starting point is defined as "0 = no pain" and the end point as "10 = unbearable pain." Participants were asked to mark their current pain levels on this line. Pain levels were assessed separately at rest, during activity, and at night.

Other: Back school education integrated with a VR headset

Lumbar joint position sense

EXPERIMENTAL

Participants were comfortably positioned, and the assessor passively moved their lumbar spine into a specific angle of flexion or extension. After holding the target angle for 3 seconds to allow proprioceptive encoding, participants were asked to actively replicate the position. The absolute error between the passively given angle and the actively replicated angle was recorded in degrees.

Other: Back school education integrated with a VR headset

Tampa Scale for Kinesiophobia

EXPERIMENTAL

This 17-item questionnaire utilizes a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree) to evaluate kinesiophobia and movement avoidance following an injury. After reverse-scoring items 4, 8, 12, and 16, a total score ranging from 17 to 68 is calculated, with higher scores indicating greater kinesiophobia.

Other: Back school education integrated with a VR headset

Functional disability

EXPERIMENTAL

Functional disability was measured with the Oswestry Disability Index (ODI) (17, 18). The ODI consists of 10 sections related to daily living activities such as personal care, lifting, walking, sitting, standing, and sleeping. Each section is scored from 0 to 5. The total score ranges from 0 to 50, categorized as no disability (0-4), mild (5-14), moderate (15-24), severe (25-34), and complete disability (35-50).

Other: Back school education integrated with a VR headset

Perceived Deficits Questionnaire

EXPERIMENTAL

Subjective cognitive function was evaluated using the Perceived Deficits Questionnaire (PDQ) developed by Sullivan et al. (19). This 20-item scale assesses different domains of cognitive function, including attention/concentration, retrospective memory, prospective memory, and planning/organization. It is scored on a 5-point Likert-type scale (0 = never, 4 = almost always). Total scores range from 0 to 80, with higher scores reflecting greater perceived cognitive impairment over the past four weeks.

Other: Back school education integrated with a VR headset

Interventions

Back school education integrated with a VR headsetOTHER

The intervention lasted for 4 weeks, comprising 2 sessions per week (8 sessions in total). Following baseline assessments, participants were randomly allocated to either the experimental or control group based on their resting pain levels. The experimental group received back school education integrated with a VR headset, whereas the control group received the standard back school education via verbal instruction from a physiotherapist. Following the education sessions, both groups performed supervised conventional low back exercises. The intervention was progressively structured over the 4-week period. Exercises were individualized according to each patient's clinical status and tolerance, following the principle of progressive overload, while strictly avoiding pain provocation.

Also known as: Low back pain exercises
Functional disabilityLumbar joint position sensePain intensityPerceived Deficits QuestionnaireTampa Scale for Kinesiophobia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • Presence of chronic low back pain for at least three months
  • A resting pain intensity of 3 to 7 on the Visual Analog Scale (VAS)
  • The cognitive ability to follow physiotherapy instructions
  • Any physical therapy program within the previous 6 months

You may not qualify if:

  • Neurological deficits
  • Vestibular pathologies
  • Major trauma
  • Active infections
  • Tumors,
  • Inflammatory diseases
  • They declined to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat Bozok University

Yozgat, Sarıkaya, 66650, Turkey (Türkiye)

Location

Related Publications (23)

  • Alvani E, Shirvani H, Shamsoddini A. Neuromuscular exercises on pain intensity, functional disability, proprioception, and balance of military personnel with chronic low back pain. The Journal of the Canadian Chiropractic Association. 2021;65(2):193.

    RESULT

  • Ibsen C, Schiøttz-Christensen B, Vinther Nielsen C, Hørder M, Schmidt AM, Maribo T. Assessment of functioning and disability in patients with low back pain-the low back pain assessment tool. Part 1: development. Disability and rehabilitation. 2022;44(17):4841-52.

    RESULT

  • de Souza IMB, Merini LR, Rodrigues RdSP, do Espírito Santo AdS, Marques AP. Association of functional disability and biopsychosocial factors in older adults with low back pain who live in the Amazonas state Brazil: a cross-sectional study. Journal of manipulative and physiological therapeutics. 2022;45(1):45-56.

    RESULT

  • Shokri P, Zahmatyar M, Falah Tafti M, Fathy M, Rezaei Tolzali M, Ghaffari Jolfayi A, et al. Non-spinal low back pain: Global epidemiology, trends, and risk factors. Health science reports. 2023;6(9):e1533.

    RESULT

  • Harris JE, Boushey C, Bruemmer B, Archer SL. Publishing Nutrition Research: A Review of Nonparametric Methods, Part 3. Journal of the American Dietetic Association. 2008;108(9):1488-96.

    RESULT

  • Sullivan MJ, Hall E, Bartolacci R, Sullivan ME, Adams H. Perceived cognitive deficits, emotional distress and disability following whiplash injury. Pain Research and Management. 2002;7(3):120-6.

    RESULT

  • Fisher K, Johnston M. Validation of the Oswestry low back pain disability questionnaire, its sensitivity as a measure of change following treatment and its relationship with other aspects of the chronic pain experience. Physiotherapy theory and practice. 1997;13(1):67-80.

    RESULT

  • Bayar K, Bayar B, Yakut E, Yakut Y. Reliability and construct validity of the Oswestry low back pain disability questionnaire in the elderly with low back pain. The Pain Clinic. 2003;15(1):55-9.

    RESULT

  • Lundberg MKE, Styf J, Carlsson SG. A psychometric evaluation of the Tampa Scale for Kinesiophobia - from a physiotherapeutic perspective. Physiotherapy Theory and Practice. 2004;20(2):121-33.

    RESULT

  • Yang Q-H, Wang X-Q. Lumbar joint position sense measurement of patients with low back pain. EFORT open reviews. 2023;8(8):639-50.

    RESULT

  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983;17(1):45-56.

    RESULT

  • Poquet N, Lin CWC, Heymans MW, van Tulder MW, Esmail R, Koes BW, et al. Back schools for acute and subacute non-specific low-back pain. The Cochrane database of systematic reviews. 2016;2016(4):CD008325.

    RESULT

  • Ahern MM, Dean LV, Stoddard CC, Agrawal A, Kim K, Cook CE, et al. The effectiveness of virtual reality in patients with spinal pain: A systematic review and meta-analysis. Pain Practice. 2020;20(6):656-75.

    RESULT

  • Li R, Li Y, Kong Y, Li H, Hu D, Fu C, et al. Virtual reality-based training in chronic low back pain: systematic review and meta-analysis of randomized controlled trials. Journal of Medical Internet Research. 2024;26:e45406.

    RESULT

  • Guo Q, Zhang L, Han LL, Gui C, Chen G, Ling C, et al. Effects of virtual reality therapy combined with conventional rehabilitation on pain, kinematic function, and disability in patients with chronic neck pain: randomized controlled trial. JMIR Serious Games. 2024;12:e42829.

    RESULT

  • Conen R, Mueller S, Tibubos AN. Integration of conventional and virtual reality approaches in augmented reality for theory-based psychoeducational intervention design for chronic low back pain: scoping review. Interactive journal of medical research. 2025;14(1):e59611.

    RESULT

  • Parreira P, Heymans MW, van Tulder MW, Esmail R, Koes BW, Poquet N, et al. Back schools for chronic non-specific low back pain. Cochrane Database of Systematic Reviews. 2017(8).

    RESULT

  • Brea-Gómez B, Torres-Sánchez I, Ortiz-Rubio A, Calvache-Mateo A, Cabrera-Martos I, López-López L, et al. Virtual Reality in the Treatment of Adults with Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. International Journal of Environmental Research and Public Health. 2021;18(22):11806.

    RESULT

  • Skidmore N, Ryan CG, Mankelow J, Martin D. Acceptability and feasibility of virtual reality to promote health literacy in primary care from the health professional's view: A qualitative study. Patient Educ Couns. 2024;123:108179.

    RESULT

  • Brown L, DiCenso-Fleming T, Ensign T, Boyd AJ, Monaghan G, Binder DS. Chronic pain education delivered with a virtual reality headset in outpatient physical therapy clinics: a multi-site exploratory trial. Am J Transl Res. 2023;15(5):3500-10.

    RESULT

  • Hernandez-Lucas P, Leirós-Rodríguez R, Mota J, García-Soidán JL. Effects of a back school-based intervention on non-specific low back pain in adults: a randomized controlled trial. BMC complementary medicine and therapies. 2023;23(1):229.

    RESULT

  • Alaca N, Acar AÖ, Öztürk S. Low back pain and sitting time, posture and behavior in office workers: A scoping review. Journal of back and musculoskeletal rehabilitation. 2025;38(5):919-43.

    RESULT

  • Anselmo A, Pagano M, Cappadona I, Cardile D, Russo F, Laudisio A, et al. A Systematic Review on the Neuropsychological Assessment of Patients with LBP: The Impact of Chronic Pain on Quality of Life. Journal of Clinical Medicine. 2024;13(20):6149.

    RESULT

MeSH Terms

Conditions

Motor ActivityPain

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisst Prof

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 25, 2026

Study Start

March 1, 2024

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly available in order to protect participant confidentiality and in accordance with institutional and ethical data protection regulations.

Locations

TU(1)