Clinical trial NCT05567861: Virtual Reality for Fibromyalgia
Official title: Observational Study on the Effect of Virtual Reality on the Pain Intensity of Patients Suffering From Fibromyalgia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Virtual Reality
Chronic Pain
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with fibromyalgia pain \> 6 months

Brief summary: Fibromyalgia is a frequent chronic pain syndrome almost often affecting women and associating diffuse chronic musculoskeletal pain (for more than 3 months), fatigue and sleep disturbances. Other varied functional symptoms are associated with it, in particular cognitive disorders and a feeling of unrested awakening.

Technological advances in virtual reality have led to recognition by the medical community as a way to improve pain and quality of life for patients.

There is a growing body of evidence supporting the use of virtual reality as an adjunct therapy to reduce acute pain in patients during medical procedures in hospital settings. There may also be a role for virtual reality in patients with chronic pain.

Detailed description: Current treatments for fibromyalgia (FM) include pharmaceutical pain medications as well as psychological programs with components of cognitive therapy, and activity management. However, pain medications are not fully effective, can be addictive, and can cause hyperalgesia. Non-pharmacological treatments for chronic pain may be associated with limiting side effects, technology-based interventions using virtual reality (VR) may be a promising alternative treatment option.

There is evidence which shows that VR can be an effective treatment for pain reduction. However, most studies which utilize VR as a method of pain reduction focus on acute pain and studies looking at VR for chronic pain are scarce.

Investigator will analyze the pain reduction and impact on behavioral mechanisms and cognition with repetitive active VR on Fibromyalgia

Eligibility criteria: Inclusion Criteria :

* Patients able to understand and sign the informed consent form for the study
* Adults aged 18 to 65 years
* Followed in algology for fibromyalgia pain \> 6 months
* With mean pain intensity ≥ 4

Exclusion Criteria :

* History of epilepsy or hypersensitivity to flashing light to limit the risk of virtual reality-induced seizures
* Previous use of VR for pain (possible bias)
* Refusal to participate
* Therapeutic modifications for pain management related to fibromyalgia during the first month of participation

Primary outcomes:
measure: Patient pain
timeFrame: month 1
Secondary outcomes:
measure: Patient pain
timeFrame: week 2, month 2
measure: Activity
timeFrame: month 1, month 2
measure: Mood
timeFrame: month 1, month 2
measure: Pain associated cognition
timeFrame: month 1, month 2
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References: