Fibromyalgia, Pain
Conditions
Brief summary
This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.
Interventions
OTHERCold Pressor Test
The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.
OTHERCold Pressor Test + Virtual Reality
The participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment
Sponsors
Naestved Hospital
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
The participants are blind to the study hypothesis and therefore the expected outcome of the tests performed
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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) |
| Pain threshold | 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) |
| Pain tolerance | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain catastrophizing | 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. |
Countries
Denmark
Outcome results
None listed