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

NCT03182556 | Completed

• 1 other identifier: mlr295
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia

Keywords

Dance Therapy; Exercise; Myofeedback; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and 12 weeks

Secondary Outcomes (6)

• Pittsburgh Sleep Quality Index (PSQI).

  At baseline and 12 weeks

• Center for Epidemiological Studies Depression Scale.

  At baseline and 12 weeks

• State-Trait Anxiety Inventory (STAI).

  At baseline and 12 weeks

• Pressure algometry.

  At baseline and 12 weeks

• McGill Questionnaire.

  At baseline and 12 weeks

Study Arms (3)

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.

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).

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.

Behavioral: Aquatic exercise

Interventions

Electromyography-Biofeedback (EMG-BFB) training BEHAVIORAL

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.

Also known as: Myofeedback, Surface electromyography biofeedback

Aquatic Exercise; Stretching

Aquatic exercise BEHAVIORAL

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).

Also known as: Aquatic Biodanza, Aquatic Biodance, Aquatic aerobic exercise

Electromyography-Biofeedback training; Stretching

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Biofeedback, Psychology; Aquatic Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Hydrotherapy; Physical Therapy Modalities; Rehabilitation

Study Officials

• Maria M Lopez-Rodriguez, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: May 11, 2012
• Primary Completion: April 17, 2013
• Study Completion: September 10, 2016
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share