- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07492784
Investigation of the Effect of a Virtual Reality-Based Back School Program on Pain, Functionality, and Kinesiophobia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sarıkaya
-
Yozgat, Sarıkaya, Turkey (Türkiye), 66650
- Yozgat Bozok University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain intensity
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.
|
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:
|
|
Experimental: Lumbar joint position sense
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.
|
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:
|
|
Experimental: Tampa Scale for Kinesiophobia
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.
|
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:
|
|
Experimental: Functional disability
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).
|
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:
|
|
Experimental: Perceived Deficits Questionnaire
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline and immediately post-intervention (4 weeks)
|
|
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.
|
At baseline and immediately post-intervention (4 weeks)
|
|
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.
|
At baseline and immediately post-intervention (4 weeks)
|
|
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).
|
At baseline and immediately post-intervention (4 weeks)
|
|
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.
|
At baseline and immediately post-intervention (4 weeks)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Back School
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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