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

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: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Myofascial release; Other: Muscle stretching; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pain intensity level change	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	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

Outcome Measure	Measure Description	Time Frame
Amount of analgesic ingested	Measured by the analgesic diary, wich is filled weekly	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): February 16, 2019
• Study Completion (Actual): March 19, 2019

Study Registration Dates

• First Submitted: January 7, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Myofascial release; Manual therapy; Muscle stretching
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID 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