Clinical trial NCT03408496: Myofascial Release of Physiological Chains and Muscle Stretching in Patients With Fibromyalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Myofascial release
Pain
Manual therapy
Muscle stretching
Quality of life
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be allocated in 3 groups. The myofascial release group, muscle stretching group and control group.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity level change
timeFrame: 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)
measure: Quality of life score change
timeFrame: 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:
measure: Amount of analgesic ingested
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
References: