Virtual Reality for Fibromyalgia

Fibromyalgia Clinical Trial

— VR_Fibro  

Official title:

Observational Study on the Effect of Virtual Reality on the Pain Intensity of Patients Suffering From Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05567861
• Other study ID #: 22-20
• Status: Recruiting
• Start date: October 11, 2022
• Est. completion date: October 2023

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Princesse Grace
• Contact: Jean-Marie AMODEO, MD
• Phone: 00 377 97 98 97 02
• Email: jmamodeo[@]chpg.mc
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Princesse Grace

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient pain	Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain	month 1
Secondary	Patient pain	Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain	week 2, month 2
Secondary	Activity	pain self-efficacy questionnaire, 0 to 60, 0 = not at all confident, 60 = completely confident	month 1, month 2
Secondary	Mood	Hospital Anxiety and Depression scale, 0 to 42, 7 or less = no symptom, 8 to 10 = doubt on symptom, 11 and more = undeniable symptom	month 1, month 2
Secondary	Pain associated cognition	Catastrophizing scale, 0 to 52, higher score indicates higher level of catastrophizing, a total score above 30 indicates clinically relevant level of catastrophizing	month 1, month 2