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

NCT04294914 | Completed

• 1 other identifier: SJ-822
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia; Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Pain catastrophizing

  through study completion, an average of 90minutes

Study Arms (2)

Fibromyalgia

ACTIVE COMPARATOR

Individuals with fibromyalgia.

Other: Cold Pressor Test; Other: Cold Pressor Test + Virtual Reality

Healthy controls

EXPERIMENTAL

Healthy, pain-free individuals

Other: Cold Pressor Test; Other: Cold Pressor Test + Virtual Reality

Interventions

Cold Pressor Test OTHER

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

Fibromyalgia; Healthy controls

Cold Pressor Test + Virtual Reality OTHER

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

Fibromyalgia; Healthy controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead
• Naestved Hospital: collaborator

Study Sites (1)

Interdisciplinary Paincenter Naestved, Naestved hospital

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (1)

• Christensen SWM, Almsborg H , M, Vain TS , M, Vaegter HB. The Effect of Virtual Reality on Cold Pain Sensitivity in Patients with Fibromyalgia and Pain-Free Individuals: A Randomized Crossover Study. Games Health J. 2023 Aug;12(4):295-301. doi: 10.1089/g4h.2022.0138. Epub 2022 Nov 28.

  PMID: 36454199 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steffan WM Christensen, PhD

  Dept. Of Health Science and Technology, Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are blind to the study hypothesis and therefore the expected outcome of the tests performed
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 4, 2020
• Study Start: February 1, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

DK (1)