Fibromyalgia Clinical Trial
Official title:
Effectiveness of a Structured Group Intervention Based on Pain Neuroscience Education for Patients With Fibromyalgia in Primary Care: a Multicenter Randomized Open-label Controlled Trial
Verified date | April 2020 |
Source | Osatzen Sociedad Vasca Medicina Familiar y Comunitaria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 140 |
Est. completion date | August 31, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of fibromyalgia stablished by the American Rheumatology College criteria 2010, - Older than 18 years - Have signed the informed consent Exclusion Criteria: - Psychiatric or neurological disorder which could prevent assimilate the training - Refusal to participate in the trial |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Osatzen Sociedad Vasca Medicina Familiar y Comunitaria |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To asses the effectiveness by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size. | Fibromyalgia Impact Questionnaire: is composed of 10 questions. It measures the functionality of patients with fibromyalgia. 0-100 and 100 the worst. | It will be measured at 1 month, 6 months and 12-months after the beginning of the intervention, | |
Secondary | To asses the decrease in pain by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size. | Brief Pain Inventory: it measures pain. The most point the worst (0-100). | t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention, | |
Secondary | To assesthe decrease in catastrophising by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size. | Pain catastrophising scale: it measures catastrophizing. The most point the worst (0-100). | t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention, | |
Secondary | 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. | Hospital Anxiety and Depression scale: 0-7 = Normal; 8-10 = Borderline 11-21 = Abnormal. | t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention, | |
Secondary | To asses the security of modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size. | Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0. | It will be measured at 12-months after the beginning of the intervention, |
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