Chronic Low Back Pain (CLBP), Chronic Pain, Low Back Pain
Conditions
Keywords
hypnotherapy, virtual reality
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.
Interventions
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.
OTHERStandard Physical Therapy
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
Sponsors
University of Beykent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactTugba Sahbaz, Associate Professor
Outcome results
None listed