Skip to main content
OpenTrials
Completed

NCT Number: NCT07492784

Investigation of the Effect of a Virtual Reality-Based Back School Program on Pain, Functionality, and Kinesiophobia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Back and Leg Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yozgat Bozok University

Yozgat, Sarıkaya, 66650, Turkey (Türkiye)

About this study

Background and Aim:

Chronic low back pain (CLBP) is a multidimensional condition associated with functional limitations, fear of movement, and proprioceptive impairments. Contemporary rehabilitation approaches, such as back school programs, are based on a biopsychosocial model and aim to enhance patient engagement. Virtual reality (VR) applications may further support these interventions by increasing motivation and providing enriched sensory feedback. This study aims to investigate the effects of a 4-week VR-based back school program on pain, disability, fear of movement, and joint position sense (JPS) in individuals with CLBP.

Methods:

The study includes 39 participants allocated into an experimental group (n=20) and a control group (n=19). The control group receives back school training through verbal instruction delivered by a physiotherapist, while the experimental group receives the same training integrated with a VR headset. Following the education sessions, both groups perform standard low back exercises under physiotherapist supervision.

Outcome measures include:

Pain intensity assessed using the Visual Analog Scale (VAS)

Disability assessed using the Oswestry Disability Index (ODI)

Lumbar joint position sense measured using a goniometric method

Fear of movement assessed using the Tampa Scale for Kinesiophobia (TSK)

Cognitive function assessed using the Perceived Deficits Questionnaire (PDQ)

All outcomes are evaluated before and after the 4-week intervention period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Back school education integrated with a VR headset

Other

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.

Other names: Low back pain exercises

Primary outcomes

  1. Pain intensity

    Time frame: At baseline and immediately post-intervention (4 weeks)

    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.

  2. Lumbar joint position sense

    Time frame: At baseline and immediately post-intervention (4 weeks)

    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.

  3. Tampa Scale for Kinesiophobia

    Time frame: At baseline and immediately post-intervention (4 weeks)

    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.

  4. Functional disability

    Time frame: At baseline and immediately post-intervention (4 weeks)

    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).

  5. Perceived Deficits Questionnaire

    Time frame: At baseline and immediately post-intervention (4 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.