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
1 other identifier
interventional
38
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2018
CompletedStudy Start
First participant enrolled
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2019
CompletedMarch 21, 2019
September 1, 2018
1.1 years
January 7, 2018
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Amount of analgesic ingested
Up to 12 weeks
Study Arms (3)
Myofascial release
EXPERIMENTALEight 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.
Muscle Stretching
EXPERIMENTALThe 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.
Control
ACTIVE COMPARATORIt 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740-560, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 7, 2018
First Posted
January 24, 2018
Study Start
January 23, 2018
Primary Completion
February 16, 2019
Study Completion
March 19, 2019
Last Updated
March 21, 2019
Record last verified: 2018-09