Clinical trial NCT03882567: Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia
Official title: Effectiveness of Electro Neuro Adaptive Regulator on Pain, Disability and Central Sensitization in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: visual analogue scale
conditioned pain modulation
disability
pressure pain threshold
temporal summation
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. . American College of Rheumatology classification criteria for Fibromyalgia.
2. . reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries;
3. on stable doses of medications for FM ≥ 4 weeks.

Exclusion Criteria:

* Patients will be excluded from enrolment if: (1) they suffer from an inflammatory rheumatic conditions; (2) have a planned elective surgery during the study period; (3) have ongoing unresolved disability claims; (4) experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis; (5) do not speak Spanish fluently.

Primary outcomes:
measure: Numerical pain ranting Scale
timeFrame: Change from Baseline of pain intensity at 3 months
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Change from Baseline of Fibromyalgia impact questionnaire at 3 months
Secondary outcomes:
measure: Conditioned pain modulation
timeFrame: Change from Baseline of CPM at 3 months
measure: Mechanical Hyperalgesia
timeFrame: Change from Baseline of PPT at 3 months
measure: Temporal Summation
timeFrame: Change from Baseline of TS at 3 months
measure: Pain Catastrophizing
timeFrame: Change from Baseline of pain catastrophizing at 3 months
measure: State Trait Anxiety Inventory
timeFrame: Change from Baseline of Anxiety at 3 months
measure: Beck Depression Inventory (BDI)
timeFrame: Change from Baseline of Depression symptoms at 3 months
measure: Tampa Scale for Kinesiophobia
timeFrame: Change from Baseline of kinesiophobia at 3 months
measure: Jenkins Sleep Scale
timeFrame: Change from Baseline of sleep scale at 3 months
measure: SF-36. Short Form-36 Health Survey
timeFrame: Change from Baseline of quality of life at 3 months
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josue Fernández-Carnero, PhD
role: STUDY_DIRECTOR
References: