Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Low Back Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Low Back Pain; Chronic Low Back Pain (CLBP)

• Registration Number: NCT06698354
• Lead Sponsor: University of Beykent

Brief Summary

This randomized, prospective study aims to evaluate the effectiveness and cost-efficiency of a Virtual Reality (VR)-assisted hypnotherapy program on quality of life in patients with chronic low back pain. The study compares a VR-assisted hypnotherapy group to a standard treatment group. Both groups will undergo a conventional physical therapy program supervised by physiotherapists for 3 weeks (15 sessions). The VR-assisted hypnotherapy group will receive additional sessions utilizing the HypnoVR software, which delivers relaxing virtual environments. Outcomes will be assessed immediately after treatment, at 1 month, and at 3 months post-treatment. Primary endpoints include pain reduction measured by the Visual Analog Scale (VAS). Secondary endpoints include functionality, quality of life, anxiety, depression, sleep quality, healthcare costs, and treatment adherence. Statistical analyses will determine the efficacy and economic impact of this innovative therapy for chronic low back pain management.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Study Start: 2024-12-02
• Primary Completion: 2025-04-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age between 50 and 80 years.
• Chronic neck pain lasting for more than 3 month

Exclusion Criteria

• Presence of newly developed neurological deficits.
• Existence of comorbid neurological diseases.
• Medical history unsuitable for the use of virtual reality (VR) glasses (e.g., visual impairment, epilepsy).
• Pregnancy.
• Changes in medication for chronic pain management within the last three months (e.g., Pregabalin, Gabapentin, Duloxetine, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity	Assessed at baseline, immediately after treatment (3 weeks), and at 1- and 3-month follow-ups.	The primary outcome is the percentage change in pain intensity, measured using the Visual Analog Scale (VAS). A reduction of ≥30% in the VAS score from baseline is considered clinically significant.

Secondary Outcome Measures

Name	Time	Method
Change in Functional Status	Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.	Functional status will be assessed using the Roland-Morris Disability Index.
Change in Quality of Life	Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.	Quality of life will be measured using the EQ-5D-5L questionnaire.
Reduction in Analgesic Use	Baseline and weekly throughout the 3-month follow-up period.	The number of days per week participants use nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen for pain management will be recorded.
Change in Anxiety and Depression Levels	Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.	Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Reduction in Healthcare Utilization	Assessed retrospectively at baseline and at the 3-month follow-up.	Healthcare utilization, including the number of clinic visits (Family Medicine, Physical Therapy, Orthopedics) and cervical imaging (X-ray, MRI), will be recorded for the 3 months prior to and after the intervention.

Trial Locations

Locations (1)

Beykent University Faculty of Medicine, Physical Therapy Unit; 🇹🇷 Istanbul, Turkey