Pain Clinical Trial
Official title:
Catastrophizing and Virtual Reality's Impact on the Pain Threshold During a Cold Pressor Test in Patients With Fibromyalgia: A Case-control Study
NCT number | NCT04294914 |
Other study ID # | SJ-822 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2020 |
Est. completion date | May 31, 2020 |
Verified date | March 2022 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.
Status | Completed |
Enrollment | 44 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Interdisciplinary Paincenter Naestved, Naestved hospital | Naestved | Zealand |
Lead Sponsor | Collaborator |
---|---|
Aalborg University | Naestved Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 |
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