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

NCT07204197 | Enrolling By Invitation

• 1 other identifier: VRLDHS1D
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Lumbar Disc Herniation; Lumbar Disc Surgery

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (6)

• Functional Capacity (Timed Up and Go Test)

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

• Functional Capacity (10-Meter Walk Test)

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

• Kinesiophobia (Tampa Scale of Kinesiophobia)

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

• 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).

• Treatment Satisfaction (Global Perceived Effect, GPE Scale)

  Post-operative day 2 (after intervention completion).

Study Arms (2)

Virtual-Reality-Assisted Physical Therapy Group

EXPERIMENTAL

Participants 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.

Other: Virtual Reality-Assisted Physical Therapy

Conventional Physical Therapy Group

ACTIVE COMPARATOR

Participants 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.

Other: Conventional Physical Therapy

Interventions

Virtual Reality-Assisted Physical Therapy OTHER

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.

Also known as: Conventional Physical Therapy

Virtual-Reality-Assisted Physical Therapy Group

Conventional Physical Therapy OTHER

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.

Conventional Physical Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (2)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

Hacettepe University Hospital Neurosurgery Department

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37548608 BACKGROUND

• 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.

  PMID: 34628908 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurological Physiotherapy and Rehabilitation, Hacettepe University

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 2, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): September 16, 2027
• Study Completion (Estimated): September 16, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)