Catastrophizing and Virtual Reality's Impact on the Pain Threshold During a Cold Pressor Test in Patients With Fibromyalgia: A Case-control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Pain intensity
Study Overview
Brief Summary
This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Masking Description
The participants are blind to the study hypothesis and therefore the expected outcome of the tests performed
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
- •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
- •No regular use of pain medication
- •No current or previous history of subacute or ongoing pain
Arms & Interventions
Fibromyalgia
Individuals with fibromyalgia.
Intervention: Cold Pressor Test (Other)
Fibromyalgia
Individuals with fibromyalgia.
Intervention: Cold Pressor Test + Virtual Reality (Other)
Healthy controls
Healthy, pain-free individuals
Intervention: Cold Pressor Test (Other)
Healthy controls
Healthy, pain-free individuals
Intervention: Cold Pressor Test + Virtual Reality (Other)
Outcomes
Primary Outcomes
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)
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)
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
- Pain catastrophizing(through study completion, an average of 90minutes)
Investigators
Steffan Wittrup Christensen
Associate professor
Aalborg University