Suprathreshold Pressure Pain Stimulation in Fibromyalgia

• Conditions: Fibromyalgia
• Interventions: Device: Suprathreshold pain stimulation

• Registration Number: NCT04047407
• Lead Sponsor: University of Castilla-La Mancha

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.

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 Timeline

• Study Start: 2019-06-03
• Study First Submitted: 2019-07-30
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-03
• Last Update Submitted: 2019-08-03
• Study First Posted: 2019-08-06
• Last Update Posted: 2019-08-06
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Suprathreshold pain stimulation	-
Fibromyalgia	Suprathreshold pain stimulation	-

Primary Outcome Measures

Name	Time	Method
Referred pain induced area after suprathreshold pressure stimulation	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.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	Inmediately after each stimulation	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.
Body regions afected by pain after suprathreshold pressure stimulation	Inmediately after each 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.

Trial Locations

Locations (1)

Hospital General Nuestra Señora del Prado; 🇪🇸 Talavera De La Reina, Toledo, Spain