NCT03882567

Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia

Effectiveness of Electro Neuro Adaptive Regulator on Pain, Disability and Central Sensitization in Patients With Fibromyalgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Universidad Rey Juan Carlos · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2018-06-30
• Primary completion: 2019-10-29
• Completion: 2019-10-31
• First posted: 2019-03-20
• Last updated: 2019-11-01

Locations

1 site across 1 country: Spain