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Efficacy of Electromyographic Biofeedback, Aerobic Exercise and Stretching in Fibromyalgia.

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ClinicalTrials.gov Identifier: NCT03182556
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
María del Mar Lopez-Rodriguez, Universidad de Almeria

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Electromyography-Biofeedback (EMG-BFB) training Behavioral: Aquatic exercise Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Electromyographic Biofeedback, Aerobic Exercise (Biodanza) and Stretching in Patients With Fibromyalgia.
Actual Study Start Date : May 11, 2012
Actual Primary Completion Date : April 17, 2013
Actual Study Completion Date : September 10, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Stretching
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.
Behavioral: Electromyography-Biofeedback (EMG-BFB) training
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.
Other Names:
  • Myofeedback
  • Surface electromyography biofeedback

Behavioral: Aquatic 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).
Other Names:
  • Aquatic Biodanza
  • Aquatic Biodance
  • Aquatic aerobic exercise

Experimental: Aquatic 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).
Behavioral: Electromyography-Biofeedback (EMG-BFB) training
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.
Other Names:
  • Myofeedback
  • Surface electromyography biofeedback

Experimental: Electromyography-Biofeedback training
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.
Behavioral: Aquatic 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).
Other Names:
  • Aquatic Biodanza
  • Aquatic Biodance
  • Aquatic aerobic exercise




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index (PSQI). [ Time Frame: At baseline and 12 weeks ]
    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.

  2. Center for Epidemiological Studies Depression Scale. [ Time Frame: At baseline and 12 weeks ]
    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.

  3. State-Trait Anxiety Inventory (STAI). [ Time Frame: At baseline and 12 weeks ]
    This consists of 40 items which evaluate the state and the trait anxiety of a person.

  4. Pressure algometry. [ Time Frame: At baseline and 12 weeks ]
    The pressure algometer (Wagner FPI 10) is an instrument valid for the measurement and location of the pressure-sensitive points.

  5. McGill Questionnaire. [ Time Frame: At baseline and 12 weeks ]
    This questionnaire was designed and proposed by Melzack and Torgerson in order to quantify pain. Thus, it evaluates both quantitative and qualitative pain aspects.

  6. Visual Analogical Scale (VAS). [ Time Frame: At baseline and 12 weeks ]
    This scale was used to assess changes in pain intensity before and after treatment, and after each training session.



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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182556


Sponsors and Collaborators
Universidad de Almeria
Investigators
Principal Investigator: Maria M Lopez-Rodriguez, PhD Universidad de Almeria

Responsible Party: María del Mar Lopez-Rodriguez, Assistant Professor, Universidad de Almeria
ClinicalTrials.gov Identifier: NCT03182556     History of Changes
Other Study ID Numbers: mlr295
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María del Mar Lopez-Rodriguez, Universidad de Almeria:
Dance Therapy
Exercise
Myofeedback
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases