Clinical trial NCT04121832: Biofeedback Training, Efficacy Evaluation of Fibromyalgia Treatment, a Pilot Study
Official title: Biofeedback Training, Efficacy Evaluation of Fibromyalgia Treatment, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biofeedback, Psychology
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a controlled clinical trial with crossover and comparison between usual care and biofeedback training, plus usual care
Primary purpose: TREATMENT

Brief summary: Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management.

In fibromyalgia. The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with fibromyalgia, and also to verify improvement induced by the technique in relation to: Quality of life; Quality of sleep; Perception of pain; Depressive symptomatology; Anxious symptomatology.

Detailed description: Background and rationale of study

Fibromyalgia (FM) is a chronic disease, it is characterised by persistent and diffused musculoskeletal pain with not well defined etiology. Fibromyalgia often occurs in comorbidity with other functional, organic and psychiatric pathologies. The main clinical manifestation of FM is pain, which is predominantly described by people with fibromyalgia as a burning sensation, stiffness, contracture and tension. Pain varies depending on moments of the day, activity levels, weather conditions, sleep cycle and perceived distress. Patients suffering from fibromyalgia commonly have functional disorders, including persistent fatigue,dysregulated sleep, cognitive slowness, bowel disorders, paresthesia. Futhermore, fibromyalgia occurs in comorbidity with depression with a percentage that varies between 22% and 80% (3,4). Moreover, some patients with fibromyalgia have anxiety disorder and other syndromes related to stress as irritable bowel. The prevalence of fibromyalgia in general population is 2%, with a peak of onset between 45-60 years. The gender prevalence varies between 0.5% and 5%, it is more common between women (\~ 4.2%) than men (\~0.2%).

Fibromyalgia has an important impact on the quality of life. Biofeedback is one of the medical devices used for the treatment of fibromyalgia, that aimes to riduce the typical symptoms and improve QoL.

Biofeedback allows to learn self-regulation of some physiological processes through feedback of recorded parameters and the goal is improving health and its performances.

Biofeedback measures muscle activity, skin temperature, electrodermal activity (sudoriparous glands activity), respiration, heart rate, blood pressure, electrical brain activity and bloodstream, it also gives a quick feedback of those personal measurements to the patient, in this way biofeedback teaches people to have a more active role in maintaining a good personal, mental and physical health (quickly and thoroughly it give person feedback of activity and biofeedback teaches people to take a more active role in maintaining personal health and mental health and physical health).

Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management (evidence were shown as regards stress menagement).

In fibromyalgia, the greatest benefits from using biofeedback are: improvement of sleep quality, improvement of self- efficacy, improvement of pain threshold, and improvement of emotional adjustment. In particular, a study conducted with HRV biofeedback, in which the sample learned resonance frequency breathing, showed dicreases in depression and pain and improved the person's system functioning.

Study objectives

The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with fibromyalgia, and also to produce a preliminary measurement of the possible improvement induced by the technique in relation to:Quality of life; Quality of sleep; Perception of pain; Depressive symptomatology; Anxious symptomatology This measure will be useful to estimate the expected improvement in future case-control studies. Study design

This is a controlled clinical trial with crossover and comparison between usual care and biofeedback training, plus usual care.

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed with fibromyalgia afferent to the clinic of pain therapy of San Giovanni hospital in Cagliari, Sardegna. Psychiatric comorbidities have no exclusion criterion

Exclusion Criteria:

- Patients with cognitive difficulties and/or diagnoses of mental retardation and male patients will not be included in the study. Male patients will be excluded because the diagnosy of FM is infrequent in male patients and it was decided not to have bias because of the low amount of patients included in the study

Primary outcomes:
measure: Quality of sleep, Sleep scale from the medical study (MOS),change is being assessed
timeFrame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
measure: Fibromyalgia Impact Questionnaire (FIQ), change is being assessed
timeFrame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
measure: Patient Health Questionnaire-9 (PHQ-9), change is being assessed
timeFrame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
measure: Bodily and emotional perception of pain (BEEP), change is being assessed
timeFrame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
measure: Sense of Coherence Scale 13- item (SOC), change is being assessed
timeFrame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
Secondary outcomes:
Other outcomes:
measure: Quality of life, Short Form Health Survey (SF-12), change is being assessed
timeFrame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
Locations:
city: Cagliari
country: Italy
facility: P.O. San Giovanni di Dio, AOU Cagliari
Study officials:
References: