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Completed

NCT Number: NCT04294914

Catastrophizing and Virtual Reality's Impact on Pain in Patients With Fibromyalgia

This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.

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Key information

Conditions

Fibromyalgia 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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interdisciplinary Paincenter Naestved, Naestved hospital

Næstved, Region Sjælland, 4700, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to understand, read and speak Danish
  • Able to independently answer a questionnaire
  • Able to give informed consent

Fibromyalgia group:

  • Confirmed diagnosed with fibromyalgia

Controls:

  • Healthy participants

Exclusion criteria

Applies for both groups:

  • Signs of anxiety, depression and post-traumatic stress syndrome that require treatment
  • Neurologic, musculoskeletal or mental illnesses that could influence the results.
  • Parallel participating in other studies, that can influence this study
  • Pregnancy

Fibromyalgia group:

  • Regulation in medication
  • Anticonvulsivant use the last week
  • Serotonin-norepinephrine reuptake Inhibitor (SNRI) the last two weeks
  • Tricykliske antidepressants (TCA) the last four weeks

Controls:

  • No regular use of pain medication
  • No current or previous history of subacute or ongoing pain

Treatment and study plan

Cold pressor test

Other

The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.

Cold Pressor Test + Virtual Reality

Other

The participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment

Primary outcomes

  1. Pain intensity

    Time frame: through study completion, an average of 90minutes

    Pain intensity during the interventions is scored using a Visual Analog Scale or Numeric Rating Scale (0 = no pain and 10 = worst known pain)

  2. Pain threshold

    Time frame: through study completion, an average of 90minutes

    Pain threshold is defined as when the participants feel the sensation changing from an unpleasant feeling to a painful experience (measured in seconds)

  3. Pain tolerance

    Time frame: through study completion, an average of 90minutes

    Pain tolerance is when the participants no longer are able to withstand the pain (measured in seconds).

Secondary outcomes

  1. Pain catastrophizing

    Time frame: through study completion, an average of 90minutes

    The pain catastrophizing score is measured by filling out the pain catastrophizing scale questionnaire. The pain catastrophizing scale consists of 13 sentences assessing pain-related thoughts or feelings. These are then divided into 3 domains: rumination, magnification and helplessness. The subject is asked to rate how well each sentence applies for them: 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree and 4 = all the time.

    The total score on the questionnaire can lie between 0 - 52 where a higher score indicates higher levels of pain catastrophizing thoughts.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Naestved Hospital

Registry information

Official study title

Catastrophizing and Virtual Reality's Impact on the Pain Threshold During a Cold Pressor Test in Patients With Fibromyalgia: A Case-control Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2020
Registry last updated
Mar 21, 2022

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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