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Completed

NCT Number: NCT03408496

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

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-560, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Myofascial Release

Other

Manual therapy

Muscle stretching

Other

Muscle stretching

Control

Other

Medical appointment

Primary outcomes

  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 outcomes

  1. Amount of analgesic ingested

    Time frame: Up to 12 weeks

    Measured by the analgesic diary, wich is filled weekly

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2018
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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