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

NCT04121832 | Completed FDA Device

• 1 other identifier: PG/2019/6248
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Biofeedback, Psychology

Outcome Measures

Primary Outcomes (5)

• Quality of sleep, Sleep scale from the medical study (MOS),change is being assessed

  Self-assessment questionnaire consisting of 12 items and is aimed at evaluating certain fundamental parameters in sleep disorders such as sleep, sleep continuity, sleep duration, sleepiness and breathing disorders during sleep. The total score is on the scale ranges from 0 to 100. Higher scores indicate more disturbed sleep

  T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)

• Fibromyalgia Impact Questionnaire (FIQ), change is being assessed

  self-administered questionnaire, consisting of 20 questions, divided into three parts: ability to carry out activities of daily life; number of days in the last week in which the patient has felt good and in which he has not been able to carry out his work due to the symptoms of FM. Questions 4 to 10 relate to the extent of FM interference with one's work, the intensity of pain and fatigue, the quality of the night's rest, the intensity of stiffness and the presence of anxiety or depression; responses range from 0 (no disturbance) to 10 (very important disorder), marked on a horizontal linear scale. The maximum FIQ score, corresponding to the highest degree of disability, is 100

  T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)

• Patient Health Questionnaire-9 (PHQ-9), change is being assessed

  Short self-administered tool used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV. The score has a range between 0 and 27. Scores between 0 and 9 indicate the presence of a sub-threshold depression. The score of 10 is indicated as the point at which the sensitivity and specificity of the instrument are recognized as optimal for highlighting depressions of clinical relevance.

  T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)

• Bodily and emotional perception of pain (BEEP), change is being assessed

  Instrument consisting of 23 items with Likert scale with six-step interval (from 0 to 5), organized in three subscales definable according to the following denomination: Emotional reaction induced by pain (including 15 items); Limitations caused by pain in the daily life (including 4 items); and Interference of pain on mood, interpersonal relationships, sleep and pleasure of living (4 items).

  T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)

• Sense of Coherence Scale 13- item (SOC), change is being assessed

  Self-administered questionnaire consisting of 13 items providing a total score and a score for each dimension: "comprehensibility" (C), which refers to the ability to perceive life events as coherent, structured and clear; "Manageability" (Ma), which refers to the ability to perceive that the available resources satisfy the needs of life; and "Significance" (Me), which refers to the feeling that life, emotionally, makes sense. The total score ranges from 13 to 91, with higher scores indicating a higher SOC.

  T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)

Other Outcomes (1)

• Quality of life, Short Form Health Survey (SF-12), change is being assessed

  T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)

Study Arms (2)

Case

EXPERIMENTAL

32 women with fibromyalgia diagnosis corresponding to the diagnostic criteria of the American College of Rheumatology (ACR) will be taken in charge at the pain therapy centre of San Giovanni di Dio Hospital. All patients over the age of 18 will be included. Other patients with rheumatologic diagnoses in comorbidity with fibromyalgia will be considered exclusion criteria/will be excluded. Patients with cognitive difficulties and / or diagnoses of intellectual disability and male patients will not be included in the study. In addiction to standard therapies, the sample will be treated with 10 sessions of biofeedback training.

Device: Biofeedback training treatment in Fibromyalgia, a pilot study

Controls

ACTIVE COMPARATOR

32 women with fibromyalgia diagnosis corresponding to the diagnostic criteria of the American College of Rheumatology (ACR) will be taken in charge at the pain therapy centre of San Giovanni di Dio. All patients over the age of 18 will be included. Other patients with rheumatologic diagnoses in comorbidity with fibromyalgia will be considered exclusion criteria/will be excluded. Moreover, patients with cognitive difficulties and / or diagnoses of mental retardation and male patients will not be included in the study. The sample will be treated only with standard therapies without the use of biofeedback training

Other: Control (treatment as usual)

Interventions

Biofeedback training treatment in Fibromyalgia, a pilot study DEVICE

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

Case

Control (treatment as usual) OTHER

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

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

P.O. San Giovanni di Dio, AOU Cagliari

Cagliari, 09100, Italy

Location

Related Publications (2)

• Carta MG, Cossu G, Primavera D, Aviles Gonzalez CI, Testa G, Stocchino S, Finco G, Littera MT, Deidda MC, Lorrai S, Madeddu C, Nardi AE, Sancassiani F. Heart Rate Variability Biofeedback Efficacy on Fatigue and Energy Levels in Fibromyalgia: A Secondary Analysis of RCT NCT0412183. J Clin Med. 2024 Jul 9;13(14):4008. doi: 10.3390/jcm13144008.

  PMID: 39064048 DERIVED

• Carta MG, Testa G, Stocchino S, Finco G, Sancassiani F, Littera MT, Deidda MC, Ventriglio A, Bhugra D, Cossu G. The efficacy of heart rate variability biofeedback training on sleep disorders and impact of fibromyalgia: Results of a phase II randomized controlled trial. J Psychosom Res. 2024 Jun;181:111664. doi: 10.1016/j.jpsychores.2024.111664. Epub 2024 Apr 6.

  PMID: 38652978 DERIVED

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: October 10, 2019
• Study Start: September 1, 2019
• Primary Completion: July 30, 2022
• Study Completion: December 23, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (1)