Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia

NCT ID: NCT03882567

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2019-10-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Electro Neuro adaptative Regulator

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

Group Type: EXPERIMENTAL

Electro Neuro adaptative Regulator

Intervention Type: OTHER

The SCENAR device has been previously described and generates high-amplitude, pulsed, damped biphasic sinusoidal current that is delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. The intensity of the interactive waveform adjusts in response to changes in skin impedance

Sham Electro Neuro adaptative Regulator

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.

Group Type: SHAM_COMPARATOR

Electro Neuro adaptative Regulator

Intervention Type: OTHER

The SCENAR device has been previously described and generates high-amplitude, pulsed, damped biphasic sinusoidal current that is delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. The intensity of the interactive waveform adjusts in response to changes in skin impedance

Interventions

Electro Neuro adaptative Regulator

The SCENAR device has been previously described and generates high-amplitude, pulsed, damped biphasic sinusoidal current that is delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. The intensity of the interactive waveform adjusts in response to changes in skin impedance

Intervention Type: OTHER

Other Intervention Names

InterX

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Josue Fernandez Carnero

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josue Fernández-Carnero, PhD

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Locations

Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Countries

Spain

Other Identifiers

03/2015

Identifier Type: -

Identifier Source: org_study_id