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OpenTrials
Active, Not Recruiting

NCT Number: NCT05567861

Virtual Reality for Fibromyalgia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Fibromyalgia Chronic Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Princesse Grace

Monaco, 98000

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient pain

    Time frame: month 1

    Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain

Secondary outcomes

  1. Patient pain

    Time frame: week 2, month 2

    Numerical Rating Scale, 0 to 10, 0 = no pain, 10 = maximal pain

  2. Activity

    Time frame: month 1, month 2

    pain self-efficacy questionnaire, 0 to 60, 0 = not at all confident, 60 = completely confident

  3. Mood

    Time frame: 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

  4. Pain associated cognition

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Princesse Grace

Other

Registry information

Official study title

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

Acronym: VR_Fibro

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 5, 2022
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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