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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294914
• Other study ID #: SJ-822
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2022
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Pain

Intervention

Other:
• Cold Pressor Test
The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.
• 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

Locations

Country	Name	City	State
Denmark	Interdisciplinary Paincenter Naestved, Naestved hospital	Naestved	Zealand

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Naestved Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	through study completion, an average of 90minutes
Primary	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)	through study completion, an average of 90minutes
Primary	Pain tolerance	Pain tolerance is when the participants no longer are able to withstand the pain (measured in seconds).	through study completion, an average of 90minutes
Secondary	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.	through study completion, an average of 90minutes