Pain Neuroscience Education as Treatment in Fibromyalgia Affected Patients

NCT03947502 | Completed

• 1 other identifier: PI2016097 (SO)
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fibromyalgia (FM) is a chronic, complex and disabling clinical entity that has an average global prevalence of 2.7%. It occurs mainly in women in a 3: 1 ratio. It is characterized by persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous systemic symptoms such as dizziness, migraine, digestive alterations or sensory intolerances. At present there is no pharmacological treatment with specific indication for fibromyalgia. Usually, non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality. The investigator's main goal is to evaluate the effectiveness at 1 year of a group educational intervention in neurobiology of pain in patients affected by fibromyalgia, in comparison with the evolution of a control group that will continue only with its usual treatments. This intervention will be carried out in the field of Primary Care and its effectiveness will be assessed by reducing or not having diagnostic criteria (reduction of areas of pain and of the severity of fibromyalgia symptoms), using the Criteria for the Diagnosis of Fibromyalgia of the American College of Rheumatology 2010 (ACR 2010).

Conditions

Fibromyalgia

Keywords

Fibromyalgia; pain; neurobiology; education; movement

Outcome Measures

Primary Outcomes (1)

• To asses the number of patients that stop fulfilling fibromyalgia criteria (American College of Reumathology 2010 criteria).

  The criteria established by the American College of Reumathology 2010 will be measured to estimate the negativization of the fibromyalgia diagnostic criteria. (Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Ménard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovský J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584. PubMed PMID: 20872595.

  It will be measured at 12-months after the beginning of the intervention,

Secondary Outcomes (5)

• To asses the effectiveness by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.

  It will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,

• To asses the decrease in pain by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.

  t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,

• To assesthe decrease in catastrophising by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.

  t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,

• To asses the decrease in anxiety and depression by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.

  t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,

• To asses the security of modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.

  It will be measured at 12-months after the beginning of the intervention,

Study Arms (2)

Intervention Group with

EXPERIMENTAL

Educational intervention in neurobiology of pain

Behavioral: Educational intervention in neurobiology of pain

Control group

NO INTERVENTION

The control group is treated with usual medication for fibromyalgia, anxiolytics, antidepressants, analgesics, ... Depending on the medical needs and criteria of patients´s primary care physician.

Interventions

Educational intervention in neurobiology of pain BEHAVIORAL

The educational intervention will intend to make the individual aware that in the processes of learning, sensitization, habituation and acquisition of beliefs about pain there are automatic unconscious mechanisms, which can be modulated through conscious behaviors. Based on this the investigators propose the active participation of patients in the process of desensitization of their central nervous system. The investigators will try to encourage attention and weaken the neuronal connections that make up the pain neuromatrix to establish new connections thanks to neuroplasticity.

Intervention Group with

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of fibromyalgia stablished by the American Rheumatology College criteria 2010,
• Older than 18 years
• Have signed the informed consent

You may not qualify if:

• Psychiatric or neurological disorder which could prevent assimilate the training
• Refusal to participate in the trial

Sponsors & Collaborators

• Osatzen Sociedad Vasca Medicina Familiar y Comunitaria: lead

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Primary Care Setting (Alango)

Model Details: Multicentre (5 nodes) randomized clinical trial, Pain neuro education based on 6 weekly classes of 2 hours for patients affected by fibromyalgia, taught by a multidisciplinary group. Controlled with usual therapies treated group.

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 13, 2019
• Study Start: November 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: August 31, 2018
• Last Updated: April 14, 2020

Record last verified: 2020-04