Effectiveness of Virtual Reality (VR) in Non-oncologic Chronic Musculoskeletal Pain

Musculoskeletal Pain Clinical Trial

Official title:

Effectiveness of Virtual Reality (VR) in Non-oncologic Chronic Musculoskeletal Pain: a Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06100926
• Other study ID #: 131/2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment options for chronic non-oncologic musculoskeletal pain are varied and include both pharmacological and non-pharmacological interventions, such as physical activity and psychotherapy. In clinical practice, the prevalent approach is pharmacological, based mainly on the use of pain modulators, such as antidepressants, cannabinoids and anti-epileptics, and on the use of traditional painkillers such as NSAIDs and opioids. In particular, the latter are still widely prescribed in clinical practice. Initially very effective in combating fibromyalgia pain, opioids, when taken chronically, lead to the development of tolerance with the need for the patient to gradually increase the dosage or switch to more powerful active drugs to obtain the same effect. In the face of fleeting and limited benefits, the risk, therefore, is that of falling back into a framework of abuse with consequent negative impact on both health and social status. In this context, the non-pharmacological approach plays a role of primary importance. In particular, exercise is currently recommended as one of the most effective management strategies. However, the implementation of exercise as a treatment for chronic pain is significantly hampered by poor patient compliance. Another non-pharmacological strategy is biofeedback (BF); however, although existing data support the use of BF, in clinical practice the results obtained have not supported expectations. A solution to these limitations could come from virtual reality (VR), an innovative method capable of simulating real-world situations and cognitive and motor tasks in a safe and stimulating environment, making the completion of activities rewarding and benefiting all those patients who need motor rehabilitation or musculoskeletal pain management.

This is a single-center interventional randomized device-controlled study, with two study arms:

• The treatment group: subjected to 5 days of VR experience and subsequently monitored using questionnaires until the 15th day after the end of the experience.

• The control group: initially placed on hold and subsequently also subjected to 5 days of VR experience only when the treatment group has finished its shift; subsequently each patient will be monitored until the 15th day after the end of the experience.

Primary endpoint:

• Demonstration of a pain reduction of at least 30% according to the VAS scale (0-100) in patients undergoing VR compared to those not undergoing VR.

Inclusion criteria - Patients aged 30-50 years who complain of chronic musculoskeletal pain lasting at least three months, without diagnosis of inflammatory causes Exclusion criteria

• Concomitant diagnosis of major psychiatric pathologies with the exception of anxiety-depressive disorder;

• Concomitant diagnosis of neurological pathologies;

• Concomitant diagnosis of inflammatory rheumatological diseases that may cause chronic pain.

Statistical analysis On the basis of the primary endpoints set, it is planned to enroll a sample of 20 patients, 10 per treatment group, considering an alpha error of 0.05 and a power of 80%. Considering a dropout of approximately 2 patients, a final sample of 24 patients is considered, 12 for each group.

Comparisons between the two groups of patients will be performed using parametric or non-parametric statistical tests, based on the distribution of the variables, using the Student or Mann-Whitney t test for continuous variables, and Chi-square or Fischer, for variable dichotomous or ordinal. Any correlations will be determined through the calculation of the Odds Ratio.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Subjects aged 30-50 years who complain of musculoskeletal pain lasting at least three months, without any inflammatory cause

Exclusion Criteria:

• Concomitant diagnosis of major psychiatric pathologies with the exception of anxiety-depressive disorder;

• Concomitant diagnosis of neurological pathologies;

• Concomitant diagnosis of inflammatory rheumatological diseases that may cause chronic pain.

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia, Primary
• Musculoskeletal Pain

Intervention

Device:
• software
virtual reality scene

Locations

Country	Name	City	State
Italy	Rheumatology Division	Udine	Friuli-Venezia Giulia

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine	University of Udine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Pain reduction of at least 30% according to the VAS scale (0-100) in subjects undergoing VR compared to those not undergoing VR.	0-20 days