Lumbar Disc HerniationNCT07309627
VR Therapy Effects in Lumbar Disc Herniation
A study testing Conventional Physiotherapy and VR in people with Lumbar Disc Herniation, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of incorporating virtual reality (VR) therapy into routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals diagnosed with lumbar disc herniation (LDH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Conventional Physiotherapy and VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lumbar disc herniation (LDH)
- Sedentary lifestyle
- Presence of low back pain for at least 3 months
- No participation in physiotherapy or structured rehabilitation programs within the previous 6 months
Who cannot join
- History of spinal surgery or spinal trauma
- Presence of vestibular disorders
- Presence of neurological diseases
- Presence of cardiopulmonary diseases
- Presence of other musculoskeletal disorders affecting participation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Üsküdar Üniversitesi
Ümraniye, Istanbul, 34000
About this study
Official title: Effect of Virtual Reality-Based Rehabilitation on Balance, Pain, Kinesiophobia, Depression, and Quality of Life in Individuals With Lumbar Disc Herniation
This study aims to evaluate the effects of incorporating virtual reality (VR) therapy into routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals diagnosed with lumbar disc herniation (LDH).
Read the detailed description
Purpose:
The purpose of this study is to evaluate the effects of adding virtual reality (VR) therapy to routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals with lumbar disc herniation (LDH).
Methods:
A total of 93 patients diagnosed with LDH will be randomly assigned into two groups: an intervention group (n=47) and a control group (n=46). Both groups will undergo a conventional physical therapy program consisting of transcutaneous electrical nerve stimulation (TENS), vacuum interference, heat application, and ultrasound therapy. In addition to the conventional program, the intervention group will receive VR-based therapy.
Participants will be assessed at baseline and at the end of the intervention period using the following outcome measures: balance assessed by the Nintendo Balance Board-based Balance System; activities of daily living assessed by the Oswestry Disability Index; back pain intensity assessed by the Visual Analog Scale; kinesiophobia assessed by the Tampa Kinesiophobia Scale; quality of life assessed by the Short Form-36 questionnaire; and depression assessed by the Beck Depression Inventory.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Conventional Physiotherapy, VR
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
Also called Virtual Reality
TENS, superficial and deep heat therapy, and interferential current + strengthening, stretching, and postural correction exercises Three times per week for six weeks, each session lasting 40 minutes,
VROther
The Virtual Reality (VR) group : conventional treatment in combination with a VR application (Balance System Assessment System and Active Video Games), (consisting of six different games at three difficulty levels (beginner, intermediate, advanced).
Each game lasted for 2 minutes and was repeated twice. Over six weeks, both groups completed a total of 18 sessions (3 sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Arm 1 - Control Group Arm Title: Control Group Arm Type: Active Comparator Description: Participants in this group will receive standard physiotherapy interventions commonly used for the management of lumbar disc herniation.
Intervention Intervention Name: Conventional Physiotherapy Intervention Type: Behavioral Intervention Description: A traditional physiotherapy program including supervised stretching, strengthening, and mobility exercises tailored for individuals with lumbar disc herniation.
Assigned Arm: Control Group Receives: Other: Conventional Physiotherapy |
| Experimental Group | Experimental | Arm 2 - Experimental Group Arm Title: Experimental Group Arm Type: Experimental Description: Participants in this group will receive a virtual reality-based exercise program designed to improve balance, reduce pain, decrease kinesiophobia, and enhance quality of life.
Intervention Intervention Name: Virtual Reality Exercise Program Intervention Type: Behavioral Intervention Description: A structured virtual reality-based exercise protocol including balance, core-strengthening, mobility tasks, and functional training tailored for lumbar disc herniation.
Assigned Arm: Experimental Group Receives: Other: Conventional Physiotherapy; Other: VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
The ODI is a 10-item questionnaire developed to assess functional impairment in individuals with back pain. It evaluates changes in self-care, lifting, walking, sitting, standing, sleeping, social life, travel, and pain. Each item is scored from 0 to 5, with the total score ranging from 0 to 50. The total score is then multiplied by 2 and expressed as a percentage, with higher scores indicating greater disability
Measured: 8 weeks
SF-36 Quality of Life Scale
The SF-36 assesses quality of life across eight domains: physical functioning, bodily pain, general health perception, vitality, mental health, social functioning, and physical and emotional roles. Its validity and reliability in Turkey were established by Pınar et al.
Measured: 8 weeks
Tampa Kinesiophobia Scale (TSK)
The TSK is a 17-item self-report questionnaire using a 4-point Likert scale to assess fear of movement and/or reinjury. Total scores are calculated by reverse-scoring items 4, 8, 12, and 16, with possible scores ranging from 17 to 68. Scores of 37 or higher indicate a high level of kinesiophobia
Measured: 8 weeks
Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item self-report Likert-type scale used to determine the frequency of depressive symptoms. Items are scored from 0 to 3, and the scale's validity and reliability in Turkey were established by Ulusoy et al.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Nov 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İzel Akçe, PT,MSc, Study chair, Üsküdar Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309627
- Sponsor's protocol ID
- deniz 1
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arias LFG, Zhang Y, Tijssen M, Wilhelm E. Virtual Reality Supported Neck Stretching Exercises to Improve Cervical Range of Motion. Annu Int Conf IEEE Eng Med Biol Soc. 2025 Jul;2025:1-7. doi: 10.1109/EMBC58623.2025.11253550.
PubMed 41336211Yuenyongchaiwat K, Chitjamnogchai C, Sermsinsaithong N, Tavonudomgit W, Mahawong L, Buranapuntalug S, Songsorn P, Thanawattano C. Benefit of home-based virtual reality aerobic exercise combined with resistance training for reversing sarcopenia and reducing depression in community-dwelling older adults with sarcopenia: a randomized control trial. Arch Gerontol Geriatr. 2026 Mar;142:106108. doi: 10.1016/j.archger.2025.106108. Epub 2025 Nov 29.
PubMed 41338160Dutta A, Hatjipanagioti K, Newsham MA, Leyland L, Rickson L, Buchanan A, Farkhatdinov I, Twamley J, Das A. Extended Reality Biofeedback for Functional Upper Limb Weakness: Mixed Methods Usability Evaluation. JMIR XR Spat Comput. 2025 Jun 3;2:e68580. doi: 10.2196/68580. eCollection 2025.
PubMed 41340847
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-Based Rehabilitation on Balance, Pain, Kinesiophobia, Depression, and Quality of Life in Individuals With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07309627
- Acronym / sponsor ID
- deniz 1
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of incorporating virtual reality (VR) therapy into routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals diagnosed with lumbar disc herniation (LDH).
Detailed description
Purpose:
The purpose of this study is to evaluate the effects of adding virtual reality (VR) therapy to routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals with lumbar disc herniation (LDH).
Methods:
A total of 93 patients diagnosed with LDH will be randomly assigned into two groups: an intervention group (n=47) and a control group (n=46). Both groups will undergo a conventional physical therapy program consisting of transcutaneous electrical nerve stimulation (TENS), vacuum interference, heat application, and ultrasound therapy. In addition to the conventional program, the intervention group will receive VR-based therapy.
Participants will be assessed at baseline and at the end of the intervention period using the following outcome measures: balance assessed by the Nintendo Balance Board-based Balance System; activities of daily living assessed by the Oswestry Disability Index; back pain intensity assessed by the Visual Analog Scale; kinesiophobia assessed by the Tampa Kinesiophobia Scale; quality of life assessed by the Short Form-36 questionnaire; and depression assessed by the Beck Depression Inventory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional PhysiotherapyArm 1 - Control Group Arm Title: Control Group Arm Type: Active Comparator Description: Participants in this group will receive standard physiotherapy interventions commonly used for the management of lumbar disc herniation. Intervention Intervention Name: Conventional Physiotherapy Intervention Type: Behavioral Intervention Description: A traditional physiotherapy program including supervised stretching, strengthening, and mobility exercises tailored for individuals with lumbar disc herniation. Assigned Arm: Control Group |
| Experimental Group | Experimental | Other: Conventional Physiotherapy, Other: VRArm 2 - Experimental Group Arm Title: Experimental Group Arm Type: Experimental Description: Participants in this group will receive a virtual reality-based exercise program designed to improve balance, reduce pain, decrease kinesiophobia, and enhance quality of life. Intervention Intervention Name: Virtual Reality Exercise Program Intervention Type: Behavioral Intervention Description: A structured virtual reality-based exercise protocol including balance, core-strengthening, mobility tasks, and functional training tailored for lumbar disc herniation. Assigned Arm: Experimental Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of lumbar disc herniation (LDH)
- Sedentary lifestyle
- Presence of low back pain for at least 3 months
- No participation in physiotherapy or structured rehabilitation programs within the previous 6 months
Key exclusion criteria (6 listed)
- History of spinal surgery or spinal trauma
- Presence of vestibular disorders
- Presence of neurological diseases
- Presence of cardiopulmonary diseases
- Presence of other musculoskeletal disorders affecting participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PhysiotherapyAlso: Virtual RealityTENS, superficial and deep heat therapy, and interferential current + strengthening, stretching, and postural correction exercises Three times per week for six weeks, each session lasting 40 minutes, | Other | Control Group, Experimental Group |
| VRThe Virtual Reality (VR) group : conventional treatment in combination with a VR application (Balance System Assessment System and Active Video Games), (consisting of six different games at three difficulty levels (beginner, intermediate, advanced). Each game lasted for 2 minutes and was repeated twice. Over six weeks, both groups completed a total of 18 sessions (3 sessions per week) | Other | Experimental Group |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 8 weeks
The ODI is a 10-item questionnaire developed to assess functional impairment in individuals with back pain. It evaluates changes in self-care, lifting, walking, sitting, standing, sleeping, social life, travel, and pain. Each item is scored from 0 to 5, with the total score ranging from 0 to 50. The total score is then multiplied by 2 and expressed as a percentage, with higher scores indicating greater disability
SF-36 Quality of Life Scale
Time frame: 8 weeks
The SF-36 assesses quality of life across eight domains: physical functioning, bodily pain, general health perception, vitality, mental health, social functioning, and physical and emotional roles. Its validity and reliability in Turkey were established by Pınar et al.
Tampa Kinesiophobia Scale (TSK)
Time frame: 8 weeks
The TSK is a 17-item self-report questionnaire using a 4-point Likert scale to assess fear of movement and/or reinjury. Total scores are calculated by reverse-scoring items 4, 8, 12, and 16, with possible scores ranging from 17 to 68. Scores of 37 or higher indicate a high level of kinesiophobia
Beck Depression Inventory (BDI)
Time frame: 8 weeks
The Beck Depression Inventory (BDI) is a 21-item self-report Likert-type scale used to determine the frequency of depressive symptoms. Items are scored from 0 to 3, and the scale's validity and reliability in Turkey were established by Ulusoy et al.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 41336211Arias LFG, Zhang Y, Tijssen M, Wilhelm E. Virtual Reality Supported Neck Stretching Exercises to Improve Cervical Range of Motion. Annu Int Conf IEEE Eng Med Biol Soc. 2025 Jul;2025:1-7. doi: 10.1109/EMBC58623.2025.11253550.
- Background: PubMed 41338160Yuenyongchaiwat K, Chitjamnogchai C, Sermsinsaithong N, Tavonudomgit W, Mahawong L, Buranapuntalug S, Songsorn P, Thanawattano C. Benefit of home-based virtual reality aerobic exercise combined with resistance training for reversing sarcopenia and reducing depression in community-dwelling older adults with sarcopenia: a randomized control trial. Arch Gerontol Geriatr. 2026 Mar;142:106108. doi: 10.1016/j.archger.2025.106108. Epub 2025 Nov 29.
- Background: PubMed 41340847Dutta A, Hatjipanagioti K, Newsham MA, Leyland L, Rickson L, Buchanan A, Farkhatdinov I, Twamley J, Das A. Extended Reality Biofeedback for Functional Upper Limb Weakness: Mixed Methods Usability Evaluation. JMIR XR Spat Comput. 2025 Jun 3;2:e68580. doi: 10.2196/68580. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İzel Akçe, PT,MSc study chair
Üsküdar Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and VR in people with Lumbar Disc Herniation, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07309627, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.