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NCT Number: NCT06698354

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

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.

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Key information

Conditions

Chronic Pain Back Pain Chronic Low Back Pain (CLBP) Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beykent University Faculty of Medicine, Physical Therapy Unit

Istanbul, Turkey (Türkiye)

Location contact

Tugba Sahbaz, Assoc Prof

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Virtual Reality-Assisted Hypnotherapy

Device

Virtual Reality-Assisted Hypnotherapy utilizes HypnoVR software delivered through VR glasses to provide a relaxing virtual environment. The intervention is integrated into a standard physical therapy program, with participants receiving 20-minute VR-assisted hypnotherapy sessions during each of the 15 supervised physical therapy sessions over a 3-week period. This approach aims to improve pain management, quality of life, and adherence to treatment in patients with chronic low back pain.

Standard physical therapy

Other

Participants in the control group will undergo a standard physical therapy program focused on the cervical region, consisting of 15 sessions over 3 weeks. Each session will be supervised by physiotherapists in a clinical setting and will include traditional physical therapy techniques such as therapeutic exercises

Primary outcomes

  1. Change in Pain Intensity

    Time frame: 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 outcomes

  1. Change in Functional Status

    Time frame: Baseline, post-treatment (3 weeks), and at 1- and 3-month follow-ups.

    Functional status will be assessed using the Roland-Morris Disability Index.

  2. Change in Quality of Life

    Time frame: 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.

  3. Reduction in Analgesic Use

    Time frame: 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.

  4. Change in Anxiety and Depression Levels

    Time frame: 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).

  5. Reduction in Healthcare Utilization

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tugba Sahbaz, Associate Professor

CONTACT

[email protected]

+90444 1997 ext. 6021

Sponsors and collaborators

Lead sponsor

University of Beykent

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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