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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07204197
Enrollment
46
Registered
2025-10-02
Start date
2025-07-17
Completion date
2027-09-16
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniation, Lumbar Disc Surgery

Keywords

lumbar disc herniation, lumbar disc surgery, physiotherapy and rehabilitation, virtual reality, pain, functional capacity, psychosomatic status

Brief 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 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.

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.

Interventions

OTHERVirtual Reality-Assisted 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.

OTHERConventional Physical Therapy

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.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Intensity (VAS)Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).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.
Pain Pressure Threshold (Algometry)Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).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.
Blood Biomediators (CRP, Cortisol, Leukocyte Count)Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).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.

Secondary

MeasureTime frameDescription
Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS)Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).Psychological status will be evaluated with the Hospital Anxiety and Depression Scale, which includes separate subscales for anxiety (HADS-A) and depression (HADS-D).
Functional Capacity (Timed Up and Go Test)Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).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.
Virtual Reality Sickness Questionnaire (VRSQ) (VR group only)Immediately before and after each VR session, approximately 30 minutes apart.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.
Treatment Satisfaction (Global Perceived Effect, GPE Scale)Post-operative day 2 (after intervention completion).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.
Functional Capacity (10-Meter Walk Test)Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).Participants will walk a 10-meter distance at a comfortable but fast pace. The time will be recorded, and gait speed will be calculated.
Kinesiophobia (Tampa Scale of Kinesiophobia)Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026