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| Name | Class |
|---|---|
| Naestved Hospital | OTHER |
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This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia | Active Comparator | Individuals with fibromyalgia. |
|
| Healthy controls | Experimental | Healthy, pain-free individuals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Pressor Test | Other | The participant submerges one limb into a tank of cold (1-2 ° C), circulating water. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Fibromyalgia group:
Controls:
Exclusion Criteria:
Applies for both groups:
Fibromyalgia group:
Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Steffan WM Christensen, PhD | Dept. Of Health Science and Technology, Aalborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Interdisciplinary Paincenter Naestved, Naestved hospital | Næstved | Region Sjælland | 4700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36454199 | Derived | Christensen SWM, Almsborg H , M, Vain TS , M, Vaegter HB. The Effect of Virtual Reality on Cold Pain Sensitivity in Patients with Fibromyalgia and Pain-Free Individuals: A Randomized Crossover Study. Games Health J. 2023 Aug;12(4):295-301. doi: 10.1089/g4h.2022.0138. Epub 2022 Nov 28. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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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.
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The participants are blind to the study hypothesis and therefore the expected outcome of the tests performed
| 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 |
|
| through study completion, an average of 90minutes |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |