FibromyalgiaNCT04294914
Catastrophizing and Virtual Reality's Impact on Pain in Patients With Fibromyalgia
A study testing Cold Pressor Test and Cold Pressor Test + Virtual Reality in people with Fibromyalgia and Pain, run by Aalborg University at 1 site in Denmark.
Trial summary
This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Pain
- What is being tested?
- Cold Pressor Test and Cold Pressor Test + Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2020to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Interdisciplinary Paincenter Naestved, Naestved hospital
Næstved, Region Sjælland, 4700
About this study
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
This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.
- Conditions
- Fibromyalgia, Pain
- Being tested
- Cold Pressor Test, Cold Pressor Test + Virtual Reality
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Pressor TestOther
The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.
Cold Pressor Test + Virtual RealityOther
The participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Active comparator | Individuals with fibromyalgia. Receives: Other: Cold Pressor Test; Other: Cold Pressor Test + Virtual Reality |
| Healthy controls | Experimental | Healthy, pain-free individuals Receives: Other: Cold Pressor Test; Other: Cold Pressor Test + Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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).
Measured: through study completion, an average of 90minutes
Secondary outcomes (1)
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.
Measured: through study completion, an average of 90minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Feb 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Naestved Hospital
- Responsible party
- Principal investigator, Steffan Wittrup Christensen, Aalborg University
- Investigators
- Steffan WM Christensen, PhD, Principal investigator, Dept. Of Health Science and Technology, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294914
- Sponsor's protocol ID
- SJ-822
- Status last verified
- Mar 2022
- First submitted
- 29 Feb 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36454199
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04294914
- Acronym / sponsor ID
- SJ-822
- Conditions
- Fibromyalgia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Naestved Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | Active comparator | Other: Cold Pressor Test, Other: Cold Pressor Test + Virtual RealityIndividuals with fibromyalgia. |
| Healthy controls | Experimental | Other: Cold Pressor Test, Other: Cold Pressor Test + Virtual RealityHealthy, pain-free individuals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able to understand, read and speak Danish
- Able to independently answer a questionnaire
- Able to give informed consent
- Confirmed diagnosed with fibromyalgia
- Healthy participants
Key exclusion criteria (13 listed)
- 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
- Regulation in medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Pressor TestThe participant submerges one limb into a tank of cold (1-2 ° C), circulating water. | Other | Fibromyalgia, Healthy controls |
| Cold Pressor Test + Virtual RealityThe participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment | Other | Fibromyalgia, Healthy controls |
Primary outcome
Pain intensity
Time frame: through study completion, an average of 90minutes
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
Time frame: through study completion, an average of 90minutes
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
Time frame: through study completion, an average of 90minutes
Pain tolerance is when the participants no longer are able to withstand the pain (measured in seconds).
1 secondary outcome
Pain catastrophizing
Time frame: through study completion, an average of 90minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Derived from this study: PubMed 36454199Christensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffan WM Christensen, PhD principal investigator
Dept. Of Health Science and Technology, Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Pressor Test and Cold Pressor Test + Virtual Reality in people with Fibromyalgia and Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: through study completion, an average of 90minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.