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

Primary Purpose

Fibromyalgia, Pain

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Cold Pressor Test

Cold Pressor Test + Virtual Reality

About this trial

This is an interventional basic science trial for Fibromyalgia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Interdisciplinary Paincenter Naestved, Naestved hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fibromyalgia

Healthy controls

Arm Description

Individuals with fibromyalgia.

Healthy, pain-free individuals

Outcomes

Primary Outcome Measures

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)

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)

Pain tolerance

Pain tolerance is when the participants no longer are able to withstand the pain (measured in seconds).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04294914

First Posted

February 29, 2020

Last Updated

March 7, 2022

Sponsor

Aalborg University

Collaborators

Naestved Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04294914

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

May 31, 2020 (Actual)

Study Completion Date

May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University

Collaborators

Naestved Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

Participant

Masking Description

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

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fibromyalgia

Arm Type

Active Comparator

Arm Description

Individuals with fibromyalgia.

Arm Title

Healthy controls

Arm Type

Experimental

Arm Description

Healthy, pain-free individuals

Intervention Type

Other

Intervention Name(s)

Cold Pressor Test

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Cold Pressor Test + Virtual Reality

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain intensity

Description

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

Title

Pain threshold

Description

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

Title

Pain tolerance

Description

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 Outcome Measure Information:

Title

Pain catastrophizing

Description

Time Frame

through study completion, an average of 90minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steffan WM Christensen, PhD

Organizational Affiliation

Dept. Of Health Science and Technology, Aalborg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Interdisciplinary Paincenter Naestved, Naestved hospital

City

Naestved

State/Province

Zealand

ZIP/Postal Code

4700

Country

Denmark

12. IPD Sharing Statement

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