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

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ClinicalTrials.gov Identifier: NCT03408496
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nina Bretas Bittar Schulze, Universidade Federal de Pernambuco

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Myofascial release Other: Muscle stretching Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be allocated in 3 groups. The myofascial release group, muscle stretching group and control group.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 23, 2018
Actual Primary Completion Date : February 16, 2019
Actual Study Completion Date : March 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Amount of analgesic ingested [ Time Frame: Up to 12 weeks ]
    Measured by the analgesic diary, wich is filled weekly



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408496


Locations
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Brazil
Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil, 50740-560
Sponsors and Collaborators
Universidade Federal de Pernambuco

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Responsible Party: Nina Bretas Bittar Schulze, Principal Investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03408496     History of Changes
Other Study ID Numbers: NSchulze
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nina Bretas Bittar Schulze, Universidade Federal de Pernambuco:
Myofascial release
Pain
Manual therapy
Muscle stretching
Quality of life

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases