FibromyalgiaNCT03182556
Efficacy of Electromyographic Biofeedback, Aerobic Exercise and Stretching in Fibromyalgia.
A study testing Electromyography-Biofeedback (EMG-BFB) training and Aquatic exercise in people with Fibromyalgia, run by Universidad de Almeria.
Trial summary
Some authors claim that patients with musculoskeletal pain tend to underestimate their levels of muscle tension. The results of studies find evidences of the deficits in the perception of muscular tension in patients with chronic pain, being this the pathogenic factor in some musculoskeletal alterations. Read more about this study
- Who is it for?
- Ages 18 to 72 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Electromyography-Biofeedback (EMG-BFB) training and Aquatic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2012to 10 Sep 2016
- 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 to 72 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 72 years and diagnosed with FMS according to 2010 ACR criteria. Before being included in the study, all the subjects must have signed an informed consent to ensure their participation, stating that it may be left at any time if were necessary.
Who cannot join
- Patients with physical or mental illness, infections, fever, hypotension, respiratory disorders which prevent the treatment realization, patients who do not maintain usual treatment during the study period or who do not perform the full intervention.
About this study
Official title: Comparison of the Efficacy of Electromyographic Biofeedback, Aerobic Exercise (Biodanza) and Stretching in Patients With Fibromyalgia.
Some authors claim that patients with musculoskeletal pain tend to underestimate their levels of muscle tension. The results of studies find evidences of the deficits in the perception of muscular tension in patients with chronic pain, being this the pathogenic factor in some musculoskeletal alterations. These studies show that patients with chronic pain can not identify their muscle tension and suggest that this contributes to maintaining pain. Thus, positive results have been found with relaxation and electromyographic biofeedback in patients with chronic pain. If these symptoms are due to excessive stress, patients should be able to benefit from regulation of muscle activity through BFB-EMG, thus learning to regulate the physiological variable. The study will be carried out in the electrotherapy laboratory of the Health Sciences Building of the University of Almeria. Initially, the sample will be chosen and the informed consent of the subjects will be obtained. Before the start of treatment, a baseline assessment of the dependent variables will be performed. Subsequently subjects will undergo three sessions of manipulative therapy over 12 weeks (one session per week). After the therapeutic intervention, a new determination of the dependent variables will be performed.
Read the detailed description
Fibromyalgia (FM) affects nearly 2.4% of the Spanish population, mostly women aged between 40 and 60. This disease, which is characterized by a disturbance in their pain regulation with an increased sensitivity to painful stimuli and a decrease of pain threshold, has a strong impact on the patients' health and their quality of life, restricting the realization of their daily activities. Moreover, it presents a high prevalence of comorbidities, which increases the needs of these patients in terms of effective therapeutic management leading to higher health requirements.
In addition to that, FM response to drug treatments is low and its symptoms become more frequent simultaneously with adverse effects, and according to that, an individualized analysis becomes necessary as well as a multidisciplinary approach, since there is no absolute treatment up to now.
This study aims to compare the improvements obtained in the quality of life, pain and other FM symptoms respectively, by means of applying physical therapies (such as aerobic biodance exercise in aquatic environment and stretching exercises) and psychological treatments, such as electromyographic biofeedback (BFB-EMGS) based training.
Objectives:
To comparatively analyze the level of improvement that can be reached by FM patients, by means of pool exercises based treatments, stretching exercises and BFB-EMGS therapies.
Methodology:
The sample of this study consisted of FM diagnosed individuals who verified the following inclusion criteria:
- Aged over 18 years and below 69 years.
- FM diagnosed according to the American College of Rheumatology (ACR) criteria.
- To continue with their unchanged drug treatment for the duration of the study.
- To attend at least 60% of sessions to be considered to have completed both aquatic aerobic exercise treatment and stretching therapy, or to complete at least 12 sessions in the BFB-EMGS training case.
In addition to that, the exclusion criteria were:
- Aged over 69 years or below 18 years.
- To be involved in other non-pharmacological treatments.
- To display disorders such as heart, kidney or liver failures, which prevent the development of treatments.
- Other physical or mental disorders that could endanger the patient's health.
- Not have completed the minimum number of sessions of the corresponding therapy. Thus, this is an experimental study with randomized clinical trial design, consisting of three intervention groups, namely, aquatic aerobics group, stretching group and BFB-EMGS with stretching group. All groups were composed of 35 patients and were assessed before and after 12 weeks of treatment by a single investigator blinded to patient allocation.
Comparisons were established within each group, before and after 12 weeks of treatment (intragroup) and between groups (intergroup). In this way, all patient were asked to sign an informed consent and their demographics and health data were recorded in the first meeting.
Dependent variables.
- FM Impact Questionnaire (FIQ).
- McGill-Melzack questionnaire.
- Visual Analog pain Scale (VAS).
- The depression scale was estimated by means of the Center for Epidemiologic Studies Depression (CES-D).
- Pressure algometry.
- The anxiety was measured by the State Anxiety Inventory (SAI).
- The sleep quality was measured by the Pittsburgh Sleep Quality Index (PSQI).
- The number of tender points in each patient. Independent variables.
- Aerobic biodance program in pool;
- Stretching exercises program;
- BFB-EMGS training;
- Conditions
- Fibromyalgia
- Being tested
- Electromyography-Biofeedback (EMG-BFB) training, Aquatic exercise
- Keywords
- Dance Therapy, Exercise, Myofeedback, Fibromyalgia
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography-Biofeedback (EMG-BFB) trainingBehavioural
Also called Myofeedback, Surface electromyography biofeedback
The Chattanooga Intelect Advanced model was used with the surface EMG for 2 independent channels. The patient can observe on the screen as columns of varying their height in the function of the degree of muscular tension. Each session was configured as follows. First, a 2 minute period for adaptation and then we continue with a 2 minute period to establish the baseline. After that, a 7 minute training trial session to reduce the muscle tension as well as a pause of about 2 minutes. Then, it continued with two more trials of 7 minutes interleaved with another 2 minute break. Thus, the whole training lasts 29 minutes approximately. The pauses between the individual trials were intended to recover the baseline level to carry out a new trial which will start from a higher level of EMG.
Aquatic exerciseBehavioural
Also called Aquatic Biodanza, Aquatic Biodance, Aquatic aerobic exercise
Aquatic Exercise program (Biodanza exercises) was carried out in a swimming-pool with a water temperature of approximately 29 ° C, preceded by a shower at a temperature of about 33-35 °C. Each session lasts an hour and they will held twice a week (Monday and Wednesday) during a period of time of three months (12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Stretching | Placebo comparator | Stretching sessions was held twice a week in the University of Almería facilities, lasting approximately one hour and they included different muscle areas exercises as well as stretching across the board. Receives: Behavioral: Electromyography-Biofeedback (EMG-BFB) training; Behavioral: Aquatic exercise |
| Aquatic Exercise | Experimental | Aquatic Exercise program (Biodanza exercises) was carried out in a swimming-pool with a water temperature of approximately 29 ° C, preceded by a shower at a temperature of about 33-35 °C. Each session lasts an hour and they will held twice a week (Monday and Wednesday) during a period of time of three months (12 weeks). Receives: Behavioral: Electromyography-Biofeedback (EMG-BFB) training |
| Electromyography-Biofeedback training | Experimental | The whole treatment will last about 12 sessions. Each one lasts about 30 and 40 minutes and will be performed continuously once a week. The frequency may be increased if the level of tonic muscle tension becomes too high. Receives: Behavioral: Aquatic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fibromyalgia Impact Questionnaire (FIQ) at 3 months.
This questionnaire was designed to evaluate the influence of FMS in the patients' daily life. A properly validated Spanish version of FIQ was applied in this study.
Measured: At baseline and 12 weeks
Secondary outcomes (6)
Pittsburgh Sleep Quality Index (PSQI).
This questionnaire consists of 19 items which allow evaluating the quality of sleep of the last month and differentiates between ''poor'' and ''good'' quality sleepers. The index is composed by seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction.
Measured: At baseline and 12 weeks
Center for Epidemiological Studies Depression Scale.
A screening measure developed to identify current depressive symptomatology related to major or clinical depression in adults and adolescents.This questionnaire is a self-report inventory contains 20 items that are scored by respondents to indicate the frequency of symptoms during the previous week.
Measured: At baseline and 12 weeks
State-Trait Anxiety Inventory (STAI).
This consists of 40 items which evaluate the state and the trait anxiety of a person.
Measured: At baseline and 12 weeks
Pressure algometry.
The pressure algometer (Wagner FPI 10) is an instrument valid for the measurement and location of the pressure-sensitive points.
Measured: At baseline and 12 weeks
McGill Questionnaire.
This questionnaire was designed and proposed by Melzack and Torgerson in order to quantify pain. Thus, it evaluates both quantitative and qualitative pain aspects.
Measured: At baseline and 12 weeks
Visual Analogical Scale (VAS).
This scale was used to assess changes in pain intensity before and after treatment, and after each training session.
Measured: At baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start11 May 2012
- Primary completion17 Apr 2013
- Study completion10 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Mar Lopez-Rodriguez, Universidad de Almeria
- Investigators
- Maria M Lopez-Rodriguez, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182556
- Sponsor's protocol ID
- mlr295
- Status last verified
- Jun 2017
- First submitted
- 5 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Electromyographic Biofeedback, Aerobic Exercise (Biodanza) and Stretching in Patients With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT03182556
- Acronym / sponsor ID
- mlr295
- Conditions
- Fibromyalgia
- Keywords
- Dance Therapy, Exercise, Myofeedback, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 11 May 2012 (actual)
- Primary completion
- 17 Apr 2013 (actual)
- Study completion
- 10 Sep 2016 (actual)
- First posted
- 9 Jun 2017 (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.
Some authors claim that patients with musculoskeletal pain tend to underestimate their levels of muscle tension. The results of studies find evidences of the deficits in the perception of muscular tension in patients with chronic pain, being this the pathogenic factor in some musculoskeletal alterations. These studies show that patients with chronic pain can not identify their muscle tension and suggest that this contributes to maintaining pain. Thus, positive results have been found with relaxation and electromyographic biofeedback in patients with chronic pain. If these symptoms are due to excessive stress, patients should be able to benefit from regulation of muscle activity through BFB-EMG, thus learning to regulate the physiological variable. The study will be carried out in the electrotherapy laboratory of the Health Sciences Building of the University of Almeria. Initially, the sample will be chosen and the informed consent of the subjects will be obtained. Before the start of treatment, a baseline assessment of the dependent variables will be performed. Subsequently subjects will undergo three sessions of manipulative therapy over 12 weeks (one session per week). After the therapeutic intervention, a new determination of the dependent variables will be performed.
Detailed description
Fibromyalgia (FM) affects nearly 2.4% of the Spanish population, mostly women aged between 40 and 60. This disease, which is characterized by a disturbance in their pain regulation with an increased sensitivity to painful stimuli and a decrease of pain threshold, has a strong impact on the patients' health and their quality of life, restricting the realization of their daily activities. Moreover, it presents a high prevalence of comorbidities, which increases the needs of these patients in terms of effective therapeutic management leading to higher health requirements.
In addition to that, FM response to drug treatments is low and its symptoms become more frequent simultaneously with adverse effects, and according to that, an individualized analysis becomes necessary as well as a multidisciplinary approach, since there is no absolute treatment up to now.
This study aims to compare the improvements obtained in the quality of life, pain and other FM symptoms respectively, by means of applying physical therapies (such as aerobic biodance exercise in aquatic environment and stretching exercises) and psychological treatments, such as electromyographic biofeedback (BFB-EMGS) based training.
Objectives:
To comparatively analyze the level of improvement that can be reached by FM patients, by means of pool exercises based treatments, stretching exercises and BFB-EMGS therapies.
Methodology:
The sample of this study consisted of FM diagnosed individuals who verified the following inclusion criteria:
- Aged over 18 years and below 69 years.
- FM diagnosed according to the American College of Rheumatology (ACR) criteria.
- To continue with their unchanged drug treatment for the duration of the study.
- To attend at least 60% of sessions to be considered to have completed both aquatic aerobic exercise treatment and stretching therapy, or to complete at least 12 sessions in the BFB-EMGS training case.
In addition to that, the exclusion criteria were:
- Aged over 69 years or below 18 years.
- To be involved in other non-pharmacological treatments.
- To display disorders such as heart, kidney or liver failures, which prevent the development of treatments.
- Other physical or mental disorders that could endanger the patient's health.
- Not have completed the minimum number of sessions of the corresponding therapy. Thus, this is an experimental study with randomized clinical trial design, consisting of three intervention groups, namely, aquatic aerobics group, stretching group and BFB-EMGS with stretching group. All groups were composed of 35 patients and were assessed before and after 12 weeks of treatment by a single investigator blinded to patient allocation.
Comparisons were established within each group, before and after 12 weeks of treatment (intragroup) and between groups (intergroup). In this way, all patient were asked to sign an informed consent and their demographics and health data were recorded in the first meeting.
Dependent variables.
- FM Impact Questionnaire (FIQ).
- McGill-Melzack questionnaire.
- Visual Analog pain Scale (VAS).
- The depression scale was estimated by means of the Center for Epidemiologic Studies Depression (CES-D).
- Pressure algometry.
- The anxiety was measured by the State Anxiety Inventory (SAI).
- The sleep quality was measured by the Pittsburgh Sleep Quality Index (PSQI).
- The number of tender points in each patient. Independent variables.
- Aerobic biodance program in pool;
- Stretching exercises program;
- BFB-EMGS training;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stretching | Placebo comparator | Behavioral: Electromyography-Biofeedback (EMG-BFB) training, Behavioral: Aquatic exerciseStretching sessions was held twice a week in the University of Almería facilities, lasting approximately one hour and they included different muscle areas exercises as well as stretching across the board. |
| Aquatic Exercise | Experimental | Behavioral: Electromyography-Biofeedback (EMG-BFB) trainingAquatic Exercise program (Biodanza exercises) was carried out in a swimming-pool with a water temperature of approximately 29 ° C, preceded by a shower at a temperature of about 33-35 °C. Each session lasts an hour and they will held twice a week (Monday and Wednesday) during a period of time of three months (12 weeks). |
| Electromyography-Biofeedback training | Experimental | Behavioral: Aquatic exerciseThe whole treatment will last about 12 sessions. Each one lasts about 30 and 40 minutes and will be performed continuously once a week. The frequency may be increased if the level of tonic muscle tension becomes too high. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 to 72 years and diagnosed with FMS according to 2010 ACR criteria. Before being included in the study, all the subjects must have signed an informed consent to ensure their participation, stating that it may be left at any time if were necessary.
Key exclusion criteria (1 listed)
- Patients with physical or mental illness, infections, fever, hypotension, respiratory disorders which prevent the treatment realization, patients who do not maintain usual treatment during the study period or who do not perform the full intervention.
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 |
|---|---|---|
| Electromyography-Biofeedback (EMG-BFB) trainingAlso: Myofeedback, Surface electromyography biofeedbackThe Chattanooga Intelect Advanced model was used with the surface EMG for 2 independent channels. The patient can observe on the screen as columns of varying their height in the function of the degree of muscular tension. Each session was configured as follows. First, a 2 minute period for adaptation and then we continue with a 2 minute period to establish the baseline. After that, a 7 minute training trial session to reduce the muscle tension as well as a pause of about 2 minutes. Then, it continued with two more trials of 7 minutes interleaved with another 2 minute break. Thus, the whole training lasts 29 minutes approximately. The pauses between the individual trials were intended to recover the baseline level to carry out a new trial which will start from a higher level of EMG. | Behavioural | Aquatic Exercise, Stretching |
| Aquatic exerciseAlso: Aquatic Biodanza, Aquatic Biodance, Aquatic aerobic exerciseAquatic Exercise program (Biodanza exercises) was carried out in a swimming-pool with a water temperature of approximately 29 ° C, preceded by a shower at a temperature of about 33-35 °C. Each session lasts an hour and they will held twice a week (Monday and Wednesday) during a period of time of three months (12 weeks). | Behavioural | Electromyography-Biofeedback training, Stretching |
Primary outcome
Change from baseline Fibromyalgia Impact Questionnaire (FIQ) at 3 months.
Time frame: At baseline and 12 weeks
This questionnaire was designed to evaluate the influence of FMS in the patients' daily life. A properly validated Spanish version of FIQ was applied in this study.
6 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI).
Time frame: At baseline and 12 weeks
Center for Epidemiological Studies Depression Scale.
Time frame: At baseline and 12 weeks
State-Trait Anxiety Inventory (STAI).
Time frame: At baseline and 12 weeks
Pressure algometry.
Time frame: At baseline and 12 weeks
McGill Questionnaire.
Time frame: At baseline and 12 weeks
Visual Analogical Scale (VAS).
Time frame: At baseline and 12 weeks
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 9 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Maria M Lopez-Rodriguez, PhD principal investigator
Universidad de Almeria
Questions about this trial
What is this clinical trial studying?
A study testing Electromyography-Biofeedback (EMG-BFB) training and Aquatic exercise in people with Fibromyalgia, run by Universidad de Almeria.
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 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change from baseline Fibromyalgia Impact Questionnaire (FIQ) at 3 months. (time frame: At baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2017.