Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia (SCENAR)

Universidad Rey Juan Carlos

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Electro Neuro adaptative Regulator

Study type: Interventional

Funder types: Other

Identifiers

NCT03882567

03/2015

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Electro Neuro adaptative Regulator

Experimental group

Description:

8 SCENAR sessions (twice a week) (30 min of duration) following the protocols for treatment several points in the body

Treatment:

Other: Electro Neuro adaptative Regulator

Sham Electro Neuro adaptative Regulator

Sham Comparator group

Description:

8 Sham SCENAR sessions (twice a week) (30 min of duration), following the same protocol tan experimental group but the machine will be turn off 30 seconds after starting on the treatment.

Treatment:

Other: Electro Neuro adaptative Regulator