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Biofeedback Training, Efficacy Evaluation of Fibromyalgia Treatment, a Pilot Study

NCT04121832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

  • Biofeedback, Psychology

Interventions

DEVICE

Biofeedback training treatment in Fibromyalgia, a pilot study

The selected sample will undergo 10 total Biofeedback Training sessions, once a week. Each session will last 45 minutes. The total duration of the treatment will be 10 weeks

OTHER

Control (treatment as usual)

The sample will be treated only with standard therapies without the use of biofeedback training for 10 weeks

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-07-30
Completion
2022-12-23
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04121832 on ClinicalTrials.gov