Suprathreshold Pressure Pain Stimulation in Fibromyalgia

NCT04047407 | Unknown

• 1 other identifier: Suprathresholds fibromyalgia
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

Reffered pain; Pain sensitivity; Fibromyalgia; Suprathreshold; Central sensitization

Outcome Measures

Primary Outcomes (1)

• 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.

  Inmediately after each stimulation

Secondary Outcomes (2)

• Pain intensity

  Inmediately after each stimulation

• Body regions afected by pain after suprathreshold pressure stimulation

  Inmediately after each stimulation

Study Arms (2)

Fibromyalgia

Device: Suprathreshold pain stimulation

Healthy volunteers

Device: Suprathreshold pain stimulation

Interventions

Suprathreshold pain stimulation DEVICE

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.

Fibromyalgia; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subject recruitment will be carried out in a local fibromyalgia association. Healthy volunteers will be recruitment among hospital and university workers.

You may qualify if:

• Age between 18 and 80 years
• Fullfilled the American Collegue of Rheumathology criteria for fibromyalgia.
• Understanding of spoken and written Spanish.

You may not qualify if:

• Diagnosed psychiatric pathology.
• Rheumatic pathology not medically controlled.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Hospital General Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Rubén Arroyo Fernández, MsC, PT

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 6, 2019
• Study Start: June 3, 2019
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)