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

Catastrophizing and Virtual Reality's Impact on the Pain Threshold During a Cold Pressor Test in Patients With Fibromyalgia: A Case-control Study

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

Study Overview

• Status: Completed
• Conditions: Pain; Fibromyalgia
• Intervention / Treatment: Other: Cold Pressor Test; Other: Cold Pressor Test + Virtual Reality

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Zealand
    • Naestved, Zealand, Denmark, 4700
      • Interdisciplinary Paincenter Naestved, Naestved hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fibromyalgia; Individuals with fibromyalgia.	Other: Cold Pressor Test; The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.; 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
Experimental: Healthy controls; Healthy, pain-free individuals	Other: Cold Pressor Test; The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Naestved Hospital
• Investigators: Principal Investigator: Steffan WM Christensen, PhD, Dept. Of Health Science and Technology, Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: February 29, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Vasoconstrictor Agents
• Other Study ID Numbers: SJ-822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No