Fibromyalgia Clinical Trial
Official title:
Effectiveness of Electro Neuro Adaptive Regulator on Pain, Disability and Central Sensitization in Patients With Fibromyalgia
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with
musculoskeletal pain syndromes such as fibromyalgia, Evidence shows that different physical
therapies could activation situations of chronic pain there is no activation of CPM.
Objectives: The purpose of this study is to measure the CPM response and determine whether
Electro Neuro Adaptative Regulator in patients with Fibromyalgia is effective in the
improvement of CPM, TS, pain intensity, disability.
Design: Double-blind, randomized placebo clinical trial. Methods: Patients with fibromyalgia
will be randomly allocated into two groups: the Electro Neuro Adaptative Regulator group
(SCENAR) or the sham technique (ST) group.
Main outcomes measures: Pain intensity (with visual analogue scale, Conditioned Pain
Modulation (CPM), Temporal Summation (TS) and Pressure Pain Thresholds (PPT´s) were the
primary outcomes and will be assessed at baseline and at 3-months follow-up. Secondary
outcome measures were the Fibromyalgia Impact Questionnaire to measure disability, Pain
Catastrophizing Scale and the Pain Anxiety Symptoms Scale, Beck Depression Inventory, Jenkins
Sleep Scale. Questionnaire of quality of life SF36.
Participants will be selected if they met the following inclusion criteria: (a) fulfilled the
1990 and 2010 American College of Rheumatology classification criteria for FM; (b) reported
an average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale during the previous week
to study commencement; (c) were on stable doses of medication for FM ≥ 4 weeks; and (d) were
aged between 18 and 65 years.
n/a
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