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

Aalborg University44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Fibromyalgia Pain

Interventions

Cold Pressor TestOTHER

The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.

Cold Pressor Test + Virtual RealityOTHER

The participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Interdisciplinary Paincenter Naestved, Naestved hospital

Næstved, Region Sjælland, Denmark

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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).

Time frame: through study completion, an average of 90minutes

Secondary Outcomes

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.

Time frame: through study completion, an average of 90minutes

Data from ClinicalTrials.gov

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