Myofascial Release of Physiological Chains and Muscle Stretching in Patients With Fibromyalgia

March 19, 2019 updated by: Nina Bretas Bittar Schulze, Universidade Federal de Pernambuco

Myofascial Release of the Trunk Physiological Chains and Muscle Stretching on Pain, Quality of Life and Functional Capacity of Patients With Fibromyalgia: Randomized Controlled Clinical Trial

Muscle stretching is a therapeutic technique commonly used by physiotherapists, but for the treatment of fibromyalgia it still has weak evidence to support its real effect. On the other hand, myofascial mobilization in the location of tender points, as it is the solution for the population, demonstrating effects on the improvement of the symptoms, but not yet achieving the minimal clinically important change. In this context, myofascial release guided by physiological chains, so far not studied, is presented as an alternative to improve pain and quality of life in patients with fibromyalgia because it acts in a global way and, probably, more effective.

This study evaluates the effect of myofascial release of the trunk physiological chains and muscle stretching on pain, quality of life and functional capacity of patients with fibromyalgia when compared to the control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50740-560
        • Universidade Federal de Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmation of the diagnosis by rheumatologists according to the diagnostic criteria established by the American College of Rheumatology of 1990 and 2010.
  • Moderate to severe pain according to the Fibromyalgia Impact Questionnaire (≥ 4).
  • Prescribed treatment (drug and/or psychological) stable in the last month before the selection for those who perform.
  • Patients who live in the metropolitan area of Recife - Pernambuco, Brazil.

Exclusion Criteria:

  • Nonpharmacologic therapies, except for psychological treatment if prescribed by the doctor at the same time of the study.
  • Skin diseases.
  • Patients classified as "very active" by the International Physical Activity Questionnaire.
  • Women who use intrauterine devices (IUD).
  • Pregnant women.
  • Patients with other associated rheumatic disease or with modified posture due to congenital anatomic alteration.
  • Severe decompensated comorbidities (cancer, thyroid disease and diabetes).
  • Infection, fever, hypotension, respiratory alterations limiting treatment.
  • Cardiovascular event in the previous year.
  • Presence of cardiac, renal or hepatic insufficiency.
  • Arterial or peripheral venous insufficiency.
  • Presence of a hypertrophic scar on the trunk.
  • Obesity grade 3.
  • Illiteracy.
  • Severe psychiatric illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Myofascial release
Eight consecutive weekly sessions lasting 40-45 minutes of myofascial release of the trunk physiological chains. The connective tissue of the flexion chain and the posterior static chain will be released. The myofascial release will be obtained through the mechanical effect produced by the friction of the therapist's hand with a surface of the patient's body, which is performed through "traces" executed with the fingers (thumb supported or middle finger on the indicator to achieve effect local) following as addressed chains. The release will be repeated until the feeling of local relaxation of the tissue.
Other: Myofascial release
Manual therapy
Experimental: Muscle Stretching
The muscle stretching protocol described by Bressan (2008) will be followed, which consists of 8 consecutive weekly sessions, lasting 40-45 minutes. In dorsal decubitus or sitting, the triceps surae, hamstring, gluteal, paravertebral, latissimocondyloideus, pectoral, trapezius and respiratory muscles will be stretched. The exercises will be performed in a series of five repetitions for 30 seconds.
Other: Muscle stretching
Muscle stretching
Active Comparator: Control
It will perform only the treatment prescribed by the responsable doctor, wich can be the use of drug and/or psychological treatment, and will be followed clinically by a rheumatologist during four medical appointments to monitor medication and follow in the analgesic's diary, according the standard procedure of attending the hospital where the patients will be recruited.
Other: Control
Medical appointment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity level change
Time Frame: Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)
Self reported pain intensity measured by the Visual Analog Scale, wich ranges from 0 to 10, where 0 means absence of pain and 10 means the worst pain already felt
Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)
Quality of life score change
Time Frame: Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)
Evaluated by the Fibromyalgia Impact Questionnaire, wich evaluates aspects of functional capacity, work status, psychological disturbances and physical symptoms. The total score ranges from 0 to 100, where higher scores have a worst impact of fibromyalgia on quality of life and functional capacity.
Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amount of analgesic ingested
Time Frame: Up to 12 weeks
Measured by the analgesic diary, wich is filled weekly
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSchulze

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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