Virtual Reality for Fibromyalgia

Active, not recruiting

• Conditions: Fibromyalgia

• Registration Number: NCT05567861
• Lead Sponsor: Centre Hospitalier Princesse Grace

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

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-05
• Study Start: 2022-10-11
• Primary Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient pain	month 1	Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco