FibromyalgiaNCT03464292
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
An observational study of Fibromyalgia and Pain, run by University of Florida at 1 site in United States.
Trial summary
Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only quantitatively but not qualitatively different from healthy controls (HC). Thus WU abnormalities of FM patients could be the result of supra-spinal and not the result of spinal pain mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Pain
- What is being tested?
- Capsaicin Patch 8% or 0.1% Capsaicin Cream
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2018to 8 Dec 2023
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents living in or near Gainesville, FL
Who may be able to join
- individuals diagnosed with fibromyalgia will have pain of duration > 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR).
- healthy, pain-free age matched controls without chronic pain
Who cannot join
- Allergy to red chili peppers;
- Pregnant;
- Significant hearing loss;
- Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
- FM patients must be willing to discontinue or hold their FM related medications for at least 5 half-lives.
Trial locations and contacts
1 site in 1 country.
About this study
Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only quantitatively but not qualitatively different from healthy controls (HC). Thus WU abnormalities of FM patients could be the result of supra-spinal and not the result of spinal pain mechanisms. The study team will test this hypothesis by sensitizing FM patients with topical capsaicin.
Read the detailed description
The study team hypothesizes that at baseline the slopes of sensitivity adjusted WU of FM patients are not statistically different from HC. However, after capsaicin application, the slopes of sensitivity adjusted WU will be significantly different from baseline and greater than those of HC, suggesting central sensitization. This would imply that FM patients are sensitive to heat pain but not sensitized.
- Conditions
- Fibromyalgia, Pain
- Being tested
- Capsaicin Patch 8% or 0.1% Capsaicin Cream, Vehicle Patch
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin Patch 8% or 0.1% Capsaicin CreamDrug
Also called Qutenza, Capsaicin No-Fuss
0.1 ml of 8% capsaicin topical patch or 0.1% capsaicin cream
Vehicle PatchOther
Control patch will be the same topical solution but will not contain capsaicin.
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Patch | Control patch will be the same topical solution but will not contain capsaicin. The patch will applied to the hand for 30 - 60 min. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed. Receives: Other: Vehicle Patch | |
| Capsaicin Patch 8% or 0.1% Capsaicin Cream | 8% capsaicin topical patch or 0.1% capsaicin cream. The patch will applied to the hand for 30 - 60 min. The cream will be applied similarly on a 3 cm2 area of the arm. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed. Receives: Drug: Capsaicin Patch 8% or 0.1% Capsaicin Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of Temporal Summation of Second Pain
A Peltier device (Pathway, Medoc) will be used to tap the skin surface with a 3 cm x 3 cm probe. The Peltier device will be used to provide very brief, repetitive, thermal stimuli (for approx. 1s) to the skin using computer controlled temperatures. Heat stimuli at intervals of 2.5 sec produce sensations of increasing pain (temporal summation), depending on the number of stimuli presented. The late sensations of warmth are delayed in onset by approximately 1.5 sec after the probe touches the skin, because the sensation depends upon stimulation of slowly conducting unmyelinated peripheral afferents.
Measured: 2 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start5 Jul 2018
- Primary completion1 Jul 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Staud, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464292
- Sponsor's protocol ID
- IRB201800479
- Other IDs
- OCR17639
- Status last verified
- May 2023
- First submitted
- 7 Mar 2018
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03464292
- Acronym / sponsor ID
- IRB201800479
- Conditions
- Fibromyalgia, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 14 Mar 2018 (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.
Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only quantitatively but not qualitatively different from healthy controls (HC). Thus WU abnormalities of FM patients could be the result of supra-spinal and not the result of spinal pain mechanisms. The study team will test this hypothesis by sensitizing FM patients with topical capsaicin.
Detailed description
The study team hypothesizes that at baseline the slopes of sensitivity adjusted WU of FM patients are not statistically different from HC. However, after capsaicin application, the slopes of sensitivity adjusted WU will be significantly different from baseline and greater than those of HC, suggesting central sensitization. This would imply that FM patients are sensitive to heat pain but not sensitized.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle Patch | – | Other: Vehicle PatchControl patch will be the same topical solution but will not contain capsaicin. The patch will applied to the hand for 30 - 60 min. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed. |
| Capsaicin Patch 8% or 0.1% Capsaicin Cream | – | Drug: Capsaicin Patch 8% or 0.1% Capsaicin Cream8% capsaicin topical patch or 0.1% capsaicin cream. The patch will applied to the hand for 30 - 60 min. The cream will be applied similarly on a 3 cm2 area of the arm. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents living in or near Gainesville, FL
Key inclusion criteria (2 listed)
- individuals diagnosed with fibromyalgia will have pain of duration > 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR).
- healthy, pain-free age matched controls without chronic pain
Key exclusion criteria (5 listed)
- Allergy to red chili peppers;
- Pregnant;
- Significant hearing loss;
- Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
- FM patients must be willing to discontinue or hold their FM related medications for at least 5 half-lives.
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 |
|---|---|---|
| Capsaicin Patch 8% or 0.1% Capsaicin CreamAlso: Qutenza, Capsaicin No-Fuss0.1 ml of 8% capsaicin topical patch or 0.1% capsaicin cream | Drug | Capsaicin Patch 8% or 0.1% Capsaicin Cream |
| Vehicle PatchControl patch will be the same topical solution but will not contain capsaicin. | Other | Vehicle Patch |
Primary outcome
Progression of Temporal Summation of Second Pain
Time frame: 2 hr
A Peltier device (Pathway, Medoc) will be used to tap the skin surface with a 3 cm x 3 cm probe. The Peltier device will be used to provide very brief, repetitive, thermal stimuli (for approx. 1s) to the skin using computer controlled temperatures. Heat stimuli at intervals of 2.5 sec produce sensations of increasing pain (temporal summation), depending on the number of stimuli presented. The late sensations of warmth are delayed in onset by approximately 1.5 sec after the probe touches the skin, because the sensation depends upon stimulation of slowly conducting unmyelinated peripheral afferents.
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 14 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Roland Staud, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Pain, run by University of Florida at 1 site in United States.
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 2 inclusion and 5 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 14 Dec 2023. 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 United States. 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?
Progression of Temporal Summation of Second Pain (time frame: 2 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2023.