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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Fibromyalgia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

The participants are blind to the study hypothesis and therefore the expected outcome of the tests performed

Study Groups

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Fibromyalgia

Individuals with fibromyalgia.

Group Type ACTIVE_COMPARATOR

Cold Pressor Test

Intervention Type OTHER

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

Cold Pressor Test + Virtual Reality

Intervention Type OTHER

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

Healthy controls

Healthy, pain-free individuals

Group Type EXPERIMENTAL

Cold Pressor Test

Intervention Type OTHER

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

Cold Pressor Test + Virtual Reality

Intervention Type OTHER

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

Interventions

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Cold Pressor Test

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

Intervention Type OTHER

Cold 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes