FibromyalgiaNCT04047407
Suprathreshold Pressure Pain Stimulation in Fibromyalgia
An observational study of Fibromyalgia, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The purpose of this study is to investigate the induced-pain characteristics after suprathreshold pressure stimulation at different intensities in fibromyalgia subjects, compared with healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Suprathreshold pain stimulation
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jun 2019to 18 Sep 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subject recruitment will be carried out in a local fibromyalgia association. Healthy volunteers will be recruitment among hospital and university workers.
Who may be able to join
- Age between 18 and 80 years
- Fullfilled the American Collegue of Rheumathology criteria for fibromyalgia.
- Understanding of spoken and written Spanish.
Who cannot join
- Diagnosed psychiatric pathology.
- Rheumatic pathology not medically controlled.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600
About this study
Official title: Pain Response Characteristics to Different Doses of Suprathreshold Pressure Stimulation in Fibromyalgia Subjects
The purpose of this study is to investigate the induced-pain characteristics after suprathreshold pressure stimulation at different intensities in fibromyalgia subjects, compared with healthy volunteers.
Read the detailed description
Fibromyalgia syndrome is a chronic painful, non-inflammatory rheumatic disease with a high negative impact on the quality of life, and is characterized by widespread pain, fatigue and generalised hyperalgesia on examination, symptoms that can be the consequence of central sensitization.
Despite several methods have successfully addressed this increased responsiveness of nociceptive neurons in the central nervous system, there is a lack of consensus about how to systematically perform them and those that are more appropriated for different syndromes. Therefore, investigating appropriate simple methods to assess clinical manifestations of central sensitization is relevant in the assessment of fibromyalgia.
The present study aims to investigate the pain response after suprathreshols pressure stimulation in fibromyalgia subjects compared with healthy volunteers.
- Conditions
- Fibromyalgia
- Being tested
- Suprathreshold pain stimulation
- Keywords
- Reffered pain, Pain sensitivity, Fibromyalgia, Suprathreshold, Central sensitization
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprathreshold pain stimulationDevice
Suprathreshold pain stimulation will be applied in the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) with a pressure algometer (Force Ten ™, Wagner Instruments, USA). Four suprathreshold pressure stimulations (pressure pain threshold + 20%, +30%, +40% and +50%) will be made for 60 seconds, with a minimum rest of 5 minutes between each stimulation.
The sequence of stimulation (ascending or descending) will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Not described Receives: Device: Suprathreshold pain stimulation | |
| Healthy volunteers | Not described Receives: Device: Suprathreshold pain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referred pain induced area after suprathreshold pressure stimulation
After each stimulation (120%, 130%, 140% and 150%), the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark). The size of the areas of referred pain will be extracted in pixels.
Measured: Inmediately after each stimulation
Secondary outcomes (2)
Pain intensity
It will be measured with a visual analog scale (VAS) of 100 millimeters in length. The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable.
Measured: Inmediately after each stimulation
Body regions afected by pain after suprathreshold pressure stimulation
The digital body chart will be divided into 15 different regions: (1) posterior head and neck area; (2) supraspinal area; (3) infraspinatus area; (4) posterior shoulder area; (5) back area; (6) posterior arm area; (7) posterior forearm area; (8) posterior hand area; (9) anterior head and neck area; (10) supraclavicular area; (11) chest area; (12) anterior shoulder area; (13) anterior arm area; (14) anterior forearm area; (15) anterior hand area. The total number of body regions afected by pain will be recorded.
Measured: Inmediately after each stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start3 Jun 2019
- Primary completion18 Sep 2019 (estimated)
- Study completion18 Sep 2019 (estimated)
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rubén Arroyo Fernández, MsC, PT, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047407
- Sponsor's protocol ID
- Suprathresholds fibromyalgia
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 6 Aug 2019
- 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 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Response Characteristics to Different Doses of Suprathreshold Pressure Stimulation in Fibromyalgia Subjects
- ClinicalTrials.gov ID
- NCT04047407
- Acronym / sponsor ID
- Suprathresholds fibromyalgia
- Conditions
- Fibromyalgia
- Keywords
- Reffered pain, Pain sensitivity, Fibromyalgia, Suprathreshold, Central sensitization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 18 Sep 2019 (estimated)
- Study completion
- 18 Sep 2019 (estimated)
- First posted
- 6 Aug 2019 (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.
The purpose of this study is to investigate the induced-pain characteristics after suprathreshold pressure stimulation at different intensities in fibromyalgia subjects, compared with healthy volunteers.
Detailed description
Fibromyalgia syndrome is a chronic painful, non-inflammatory rheumatic disease with a high negative impact on the quality of life, and is characterized by widespread pain, fatigue and generalised hyperalgesia on examination, symptoms that can be the consequence of central sensitization.
Despite several methods have successfully addressed this increased responsiveness of nociceptive neurons in the central nervous system, there is a lack of consensus about how to systematically perform them and those that are more appropriated for different syndromes. Therefore, investigating appropriate simple methods to assess clinical manifestations of central sensitization is relevant in the assessment of fibromyalgia.
The present study aims to investigate the pain response after suprathreshols pressure stimulation in fibromyalgia subjects compared with healthy volunteers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | Device: Suprathreshold pain stimulation |
| Healthy volunteers | – | Device: Suprathreshold pain stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject recruitment will be carried out in a local fibromyalgia association. Healthy volunteers will be recruitment among hospital and university workers.
Key inclusion criteria (3 listed)
- Age between 18 and 80 years
- Fullfilled the American Collegue of Rheumathology criteria for fibromyalgia.
- Understanding of spoken and written Spanish.
Key exclusion criteria (2 listed)
- Diagnosed psychiatric pathology.
- Rheumatic pathology not medically controlled.
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 |
|---|---|---|
| Suprathreshold pain stimulationSuprathreshold pain stimulation will be applied in the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) with a pressure algometer (Force Ten ™, Wagner Instruments, USA). Four suprathreshold pressure stimulations (pressure pain threshold + 20%, +30%, +40% and +50%) will be made for 60 seconds, with a minimum rest of 5 minutes between each stimulation. The sequence of stimulation (ascending or descending) will be randomized. | Device | Fibromyalgia, Healthy volunteers |
Primary outcome
Referred pain induced area after suprathreshold pressure stimulation
Time frame: Inmediately after each stimulation
After each stimulation (120%, 130%, 140% and 150%), the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark). The size of the areas of referred pain will be extracted in pixels.
2 secondary outcomes
Pain intensity
Time frame: Inmediately after each stimulation
Body regions afected by pain after suprathreshold pressure stimulation
Time frame: Inmediately after each stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- 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.
Rubén Arroyo Fernández, MsC, PT principal investigator
University of Castilla-La Mancha
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, run by University of Castilla-La Mancha at 1 site in Spain.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2019. 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 Spain. 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?
Results are not available in the source record.
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?
Referred pain induced area after suprathreshold pressure stimulation (time frame: Inmediately after each stimulation). 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 6 Aug 2019.