Suprathreshold Pressure Pain Stimulation in Fibromyalgia

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.

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Suprathreshold pain stimulation

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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Spain
  • Toledo
    • Talavera De La Reina, Toledo, Spain, 45600
      • Hospital General Nuestra Señora del Prado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	Device: Suprathreshold pain stimulation; 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	Device: Suprathreshold pain stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Inmediately after each stimulation

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Investigators: Principal Investigator: Rubén Arroyo Fernández, MsC, PT, University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2019
• Primary Completion (ANTICIPATED): September 18, 2019
• Study Completion (ANTICIPATED): September 18, 2019

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 3, 2019
• First Posted (ACTUAL): August 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 3, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Fibromyalgia; Central sensitization; Pain sensitivity; Reffered pain; Suprathreshold
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Suprathresholds fibromyalgia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No