Efficacy of Electromyographic Biofeedback, Aerobic Exercise and Stretching in Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

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.
    

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;
    

Intervention name(s): Electromyography-Biofeedback (EMG-BFB) training; Aquatic exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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 intervention name(s): Myofeedback; Surface electromyography biofeedback; Aquatic Biodanza; Aquatic Biodance; Aquatic aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Dance Therapy; Exercise; Myofeedback; Fibromyalgia