Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia

Conditioned pain modulation

After an interval of 5 minutes CPM was assessed by replicating the TS assessment associated with a conditioning stimulus for eliciting CPM. The conditioning stimulus was an occlusion cuff at the left arm inflated, at a rate of 20 mmHg/s until the subject reports "the first sensation of pain". Acquired pressure at this point remained for 30 seconds. The subject described the intensity of pain, because of occlusion in the arm, on a verbal numerical rating scale (0 = no pain and 10 = worst possible pain). Then cuff inflation was increased or decreased until the intensity of pain will be 3/10 in verbal rating scale

Time frame: Change from Baseline of CPM at 3 months

Mechanical Hyperalgesia

Pressure Pain Thresholds (PPTs) were assessed using algometry in the thumb (dorsal aspect of the distal phalanx). The PPT is defined as the lowest pressure that, using standardized testing conditions, needs to be applied to cause the slightest sensation of pain. It is a reliable and widely used measure

Time frame: Change from Baseline of PPT at 3 months

Temporal Summation

The degree of TS or wind-up will be evaluated in response to 10 applications (pulses) of the algometer, with an approximate rate of pressure increase of 2 Kg/s, at the previously defined PPT at the dorsal surface of the right-hand middle finger midway between the first and second distal joints, and at the middle of the right-hand side upper trapezius belly. Participants were asked to rate the intensity and unpleasantness of the pain intuitively of the first, fifth, and tenth pulse on a numeric pain rating scale.

Time frame: Change from Baseline of TS at 3 months

Pain Catastrophizing

The Spanish version of the Pain Catastrophizing Scale (PCS) was used to assess catastrophic thoughts about pain, which has shown appropriate psychometric properties.

Time frame: Change from Baseline of pain catastrophizing at 3 months

State Trait Anxiety Inventory

All participants will complete the Spanish version of the trait subscale of the State Trait Anxiety Inventory (STAI-T). The STAI-T has been found to possess adequate reliability (alpha coefficients of 0.93, test-retest reliability of 0.80) and validity.

Time frame: Change from Baseline of Anxiety at 3 months

Beck Depression Inventory (BDI)

The level of depressive symptomatology was measured by the Spanish version of the Beck Depression Inventory (BDI-II); a self-report measure that assesses affective, cognitive and somatic symptoms of depression.

Time frame: Change from Baseline of Depression symptoms at 3 months

Tampa Scale for Kinesiophobia

Developed by Miller, will be used to assess fear of movement and injury. We'll use the original 17-item version, which has shown good psychometric guarantees

Time frame: Change from Baseline of kinesiophobia at 3 months

Jenkins Sleep Scale

The Jenkins Sleep Scale (JSS) is a 4-item self-report questionnaire designed to measure how often a subject has experienced sleep problems in the past month and has been studied in FM patients and found to be valid, reliable, and able to detect change after treatment.

Time frame: Change from Baseline of sleep scale at 3 months

SF-36. Short Form-36 Health Survey

The Health related of quality of life will be selected primary outcome. It is a multipurpose, form health survey that includes 36 items taken directly from eight scale scores (physical functioning \[PF\], role-physical \[RP\], bodily pain \[BP\], general health \[GH\], vitality \[VT\], social functioning \[SF\], role-emotional \[RE\], and mental health \[MH\]).

Time frame: Change from Baseline of quality of life at 3 months