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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06100926
Other study ID # 131/2023
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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