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

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

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

Conditions
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Fibromyalgia, Pain

Intervention / Treatment
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* Other: Cold Pressor Test
* Other: Cold Pressor Test + Virtual Reality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Half the participants will start with intervention 1 after which they will crossover to intervention 2. The other half will start start with intervention 2 before crossing over to intervention 1.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibromyalgia<br>Individuals with fibromyalgia. | Other: Cold Pressor Test<br>* The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.<br>Other: Cold Pressor Test + Virtual Reality<br>* The participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment<br>|
| Experimental: Healthy controls<br>Healthy, pain-free individuals | Other: Cold Pressor Test<br>* The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.<br>Other: Cold Pressor Test + Virtual Reality<br>* The participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity during the interventions is scored using a Visual Analog Scale or Numeric Rating Scale (0 = no pain and 10 = worst known pain) | through study completion, an average of 90minutes | 
| Pain threshold | Pain threshold is defined as when the participants feel the sensation changing from an unpleasant feeling to a painful experience (measured in seconds) | through study completion, an average of 90minutes | 
| Pain tolerance | Pain tolerance is when the participants no longer are able to withstand the pain (measured in seconds). | through study completion, an average of 90minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain catastrophizing | 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. | through study completion, an average of 90minutes |