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Lumbar Disc HerniationNCT07204197

Effectiveness of Virtual Reality-Assisted Physical Therapy in the Acute Phase After Lumbar Disc Surgery

A study testing Virtual Reality-Assisted Physical Therapy and Conventional Physical Therapy in people with Lumbar Disc Herniation and Lumbar Disc Surgery, run by Hacettepe University at 2 sites in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the effectiveness of virtual reality-assisted physical therapy in the acute postoperative period after lumbar disc surgery. The main questions it aims to answer are: Does virtual reality-assisted physical therapy reduce pain more effectively than conventional physical… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lumbar Disc Herniation, Lumbar Disc Surgery
What is being tested?
Virtual Reality-Assisted Physical Therapy and Conventional Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
2 sitesTurkey (Türkiye)
Study dates
17 Jul 2025to 16 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Adults aged 18-65 years.
  • Undergoing lumbar discectomy surgery (L4-L5 or L5-S1 levels).
  • Able to start postoperative physical therapy on day 1 after surgery.
  • Willing and able to provide informed consent.
  • Sufficient cognitive and physical ability to participate in physical therapy and virtual reality sessions.

Who cannot join

  • History of previous lumbar spine surgery.
  • Severe neurological deficits (e.g., cauda equina syndrome, progressive motor weakness).
  • Diagnosed epilepsy, severe psychiatric illness, or other conditions contraindicate VR use.
  • Significant visual or vestibular impairments preventing safe VR participation.
  • Uncontrolled systemic diseases (e.g., cardiovascular, respiratory, or metabolic instability).
  • Pregnancy.
  • Inability to understand study instructions or complete outcome assessments.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)2 sites
  • Hacettepe University Faculty of Physical Therapy and Rehabilitation

    Ankara, Ankara, 06000

  • Hacettepe University Hospital Neurosurgery Department

    Ankara, Ankara, 06000

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effectiveness of Virtual Reality-Assisted Physical Therapy in the Acute Period After Lumbar Disc Surgery

The goal of this clinical trial is to evaluate the effectiveness of virtual reality-assisted physical therapy in the acute postoperative period after lumbar disc surgery.

The main questions it aims to answer are:

Read more
  • Does virtual reality-assisted physical therapy reduce pain more effectively than conventional physical therapy?
  • Does it improve functional recovery, pain threshold, and blood biomediator levels?
  • Does it reduce anxiety and kinesiophobia in the early rehabilitation period?

Researchers will compare virtual reality-assisted physical therapy with standard physical therapy to determine whether virtual reality provides additional therapeutic benefits.

Participants will:

  • Undergo standard postoperative physical therapy after lumbar disc surgery.
  • Some participants will additionally perform virtual reality-based rehabilitation exercises.
  • Be evaluated for pain severity, functional improvement, blood biomediators, pain threshold, and psychological outcomes.
Read the detailed description

Lumbar disc herniation (LDH) is one of the most common musculoskeletal disorders and a major cause of low back pain worldwide. It occurs when the intervertebral disc extends beyond its anatomical boundaries, compressing neural structures and leading to pain, disability, and reduced quality of life. Although most patients are treated conservatively, approximately 15% require surgical intervention. Postoperative pain is one of the most significant challenges after lumbar disc surgery, reported in up to 70% of patients in the acute period. Insufficient pain management may delay mobilization, prolong hospitalization, increase healthcare costs, and negatively affect both physical and psychological recovery.

Pharmacological treatments, such as NSAIDs, opioids, muscle relaxants, and neuropathic pain agents, are commonly used for postoperative pain control. However, their potential side effects and limited efficacy have raised interest in non-pharmacological interventions. Conventional physical therapy protocols-mobilization, exercise, manual therapy, and patient education-are central to postoperative rehabilitation, improving mobility, functional recovery, and independence. Early mobilization within the first days after surgery has been shown to reduce complications and accelerate healing.

In recent years, technology-based approaches have emerged as complementary or alternative rehabilitation methods. Among them, virtual reality (VR) offers interactive, multisensory, and engaging environments that can contribute to both physical and psychological recovery. VR has shown therapeutic potential in pain management by diverting attention, reducing anxiety and stress, and promoting patient engagement in rehabilitation. Importantly, VR has demonstrated effectiveness in musculoskeletal conditions, neurological rehabilitation, and postoperative care in other surgical populations.

Despite growing evidence, there is a lack of comprehensive studies evaluating VR in the acute postoperative phase after lumbar disc surgery, particularly in comparison with conventional physical therapy protocols. This study aims to address this gap by investigating the effectiveness of VR-assisted physical therapy versus conventional physical therapy in patients undergoing lumbar discectomy.

The primary outcomes include pain intensity, pain threshold, and blood biomediator levels. Secondary outcomes include functional recovery, kinesiophobia, and anxiety. By systematically comparing both interventions, this trial seeks to determine the advantages and limitations of VR-assisted rehabilitation, with the goal of developing innovative, safe, and effective strategies for postoperative care.

Being tested
Virtual Reality-Assisted Physical Therapy, Conventional Physical Therapy
Keywords
lumbar disc herniation, lumbar disc surgery, physiotherapy and rehabilitation, virtual reality, pain, functional capacity, psychosomatic status
Medical subject headings
Intervertebral Disc Displacement, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality-Assisted Physical TherapyOther

    Also called Conventional Physical Therapy

    VR Assisted PT intervention, combines a standardized postoperative physical therapy program with an additional 20-minute immersive VR session. The VR component is relaxation-focused and interactive, making the total session length 60 minutes. The distinguishing feature is the integration of VR technology into early rehabilitation after lumbar disc surgery, which is not part of conventional therapy.

  • Conventional Physical TherapyOther

    This intervention consists of the same standardized physical therapy program as the VR group, delivered for 60 minutes daily by increasing exercise repetitions and intensity. The distinguishing feature is that it does not include any VR component, allowing direct comparison of physical therapy alone versus VR-assisted therapy.

Study groups in NCT07204197
Study groupRoleWhat they receive
Virtual-Reality-Assisted Physical Therapy GroupExperimentalParticipants assigned to this group will receive a standardized 40-minute physical therapy program starting on postoperative day 1, followed by a 20-minute immersive virtual reality (VR) session. The VR application provides a relaxation-focused, interactive environment designed to reduce pain perception, anxiety, and stress while supporting engagement in rehabilitation. Sessions are delivered once daily during hospitalization. Patients are monitored for comfort and potential side effects such as dizziness or nausea, and all procedures are supervised by a physiotherapist to ensure safety and adherence.
Receives: Other: Virtual Reality-Assisted Physical Therapy
Conventional Physical Therapy GroupActive comparatorParticipants in this group will receive the same standardized physical therapy program as the VR group, beginning on postoperative day 1. To match the 60-minute session length, exercise repetitions and intensity are increased instead of adding virtual reality. Thus, both groups complete identical physical therapy content, with the only difference being the addition of a VR session in the intervention group. All sessions are delivered once daily during hospitalization and supervised by a physiotherapist.
Receives: Other: Conventional Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity (VAS)

    Pain severity will be assessed using a 10 cm Visual Analog Scale (VAS), where participants mark their perceived pain level ranging from 0 (no pain) to 10 (worst imaginable pain). Both resting pain and pain during the most difficult daily activity will be recorded.

    Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).

  2. Pain Pressure Threshold (Algometry)

    Pressure pain thresholds will be measured using an algometer applied to quadratus lumborum, tibialis anterior, and iliopsoas muscles. This method provides an objective evaluation of pain sensitivity in targeted muscle groups.

    Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).

  3. Blood Biomediators (CRP, Cortisol, Leukocyte Count)

    Blood samples will be collected to analyze inflammatory and stress-related biomarkers associated with postoperative pain. Routine venous blood collection (8-10 cc) will be performed, and analyses will be conducted in a central laboratory.

    Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).

Secondary outcomes (6)
  1. Functional Capacity (Timed Up and Go Test)

    Participants will be asked to rise from a chair, walk 3 meters, turn around, walk back, and sit down. The total time will be recorded in seconds as an indicator of mobility and functional performance.

    Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).

  2. Functional Capacity (10-Meter Walk Test)

    Participants will walk a 10-meter distance at a comfortable but fast pace. The time will be recorded, and gait speed will be calculated.

    Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).

  3. Kinesiophobia (Tampa Scale of Kinesiophobia)

    Fear of movement and reinjury will be measured using the validated Turkish version of the 17-item Tampa Scale of Kinesiophobia. Higher scores indicate greater movement-related fear.

    Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).

  4. Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS)

    Psychological status will be evaluated with the Hospital Anxiety and Depression Scale, which includes separate subscales for anxiety (HADS-A) and depression (HADS-D).

    Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).

  5. Treatment Satisfaction (Global Perceived Effect, GPE Scale)

    Participants will rate their overall improvement after the intervention compared to their pre-treatment condition on a 7-point Likert scale, ranging from "completely recovered" to "worse than ever."

    Measured: Post-operative day 2 (after intervention completion).

  6. Virtual Reality Sickness Questionnaire (VRSQ) (VR group only)

    Presence and severity of VR-related symptoms such as dizziness, nausea, or visual discomfort will be assessed using the validated Turkish version of the Virtual Reality Sickness Questionnaire.

    Measured: Immediately before and after each VR session, approximately 30 minutes apart.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start17 Jul 2025
  3. Primary completion16 Sep 2027 (estimated)
  4. Study completion16 Sep 2027 (estimated)

Resources

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
Model description
This study uses a randomized, controlled, parallel-group design. Participants undergoing lumbar disc surgery will be randomly assigned to one of two groups: (1) Virtual Reality-Assisted Physical Therapy or (2) Conventional Physical Therapy. Both groups will receive interventions starting from postoperative day 1, until the day of discharge and outcomes will be compared between the two groups.
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07204197
Sponsor's protocol ID
VRLDHS1D
Status last verified
Sep 2025
First submitted
16 Sep 2025
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because of patient privacy and confidentiality concerns.

Publications

  • Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, Meziat-Filho N. Effectiveness of Cognitive Functional Therapy Versus Core Exercises and Manual Therapy in Patients With Chronic Low Back Pain After Spinal Surgery: Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105.

    PubMed 37548608
  • He W, Wang Q, Hu J, Lin S, Zhang K, Wang F, Xu C, Li F, Xiao J, Li X, Tang F. A randomized trial on the application of a nurse-led early rehabilitation program after minimally invasive lumbar internal fixation. Ann Palliat Med. 2021 Sep;10(9):9820-9829. doi: 10.21037/apm-21-2294.

    PubMed 34628908

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality-Assisted Physical Therapy and Conventional Physical Therapy in people with Lumbar Disc Herniation and Lumbar Disc Surgery, run by Hacettepe University at 2 sites 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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Pain Intensity (VAS) (time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).). The study lists 3 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 NCT07204197, which also lists 2 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 2 Oct 2025.

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