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

Not Applicable

• Conditions: Lumbar Disc Herniation; Lumbar Disc Surgery

• Registration Number: NCT07204197
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2025-07-17
• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2027-09-16
• Study Completion: 2027-09-16

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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).
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."
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.

Trial Locations

Locations (2)

Hacettepe University Faculty of Physical Therapy and Rehabilitation; Ankara, Ankara, Turkey (Türkiye)

Hacettepe University Hospital Neurosurgery Department; Ankara, Ankara, Turkey (Türkiye)