Biofeedback, PsychologyNCT04121832
Biofeedback Training, Efficacy Evaluation of Fibromyalgia Treatment, a Pilot Study
A study testing Biofeedback training treatment in Fibromyalgia, a pilot study in people with Biofeedback, Psychology, run by University of Cagliari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Biofeedback, Psychology
- What is being tested?
- Biofeedback training treatment in Fibromyalgia, a pilot study
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Biofeedback, Psychology
- Being tested
- Biofeedback training treatment in Fibromyalgia, a pilot study, Control (treatment as usual)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback training treatment in Fibromyalgia, a pilot studyDevice
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
Control (treatment as usual)Other
The sample will be treated only with standard therapies without the use of biofeedback training for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Control (treatment as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Sep 2019
- Primary completion30 Jul 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Biofeedback, PsychologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a controlled clinical trial with crossover and comparison between usual care and biofeedback training, plus usual care
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Giovanni Carta, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121832
- Sponsor's protocol ID
- PG/2019/6248
- Status last verified
- Mar 2023
- First submitted
- 6 Jun 2019
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 39064048Carta 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.
PubMed 38652978
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback Training, Efficacy Evaluation of Fibromyalgia Treatment, a Pilot Study
- ClinicalTrials.gov ID
- NCT04121832
- Acronym / sponsor ID
- PG/2019/6248
- Conditions
- Biofeedback, Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a controlled clinical trial with crossover and comparison between usual care and biofeedback training, plus usual care
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Device: Biofeedback training treatment in Fibromyalgia, a pilot study32 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. |
| Controls | Active comparator | Other: Control (treatment as usual)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback training treatment in Fibromyalgia, a pilot studyThe 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 | Device | Case |
| Control (treatment as usual)The sample will be treated only with standard therapies without the use of biofeedback training for 10 weeks | Other | Controls |
Primary outcome
Quality of sleep, Sleep scale from the medical study (MOS),change is being assessed
Time frame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
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
Fibromyalgia Impact Questionnaire (FIQ), change is being assessed
Time frame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
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
Patient Health Questionnaire-9 (PHQ-9), change is being assessed
Time frame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
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.
Bodily and emotional perception of pain (BEEP), change is being assessed
Time frame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
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).
Sense of Coherence Scale 13- item (SOC), change is being assessed
Time frame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 39064048Carta 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.
- Derived from this study: PubMed 38652978Carta 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback training treatment in Fibromyalgia, a pilot study in people with Biofeedback, Psychology, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of sleep, Sleep scale from the medical study (MOS),change is being assessed (time frame: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121832, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.