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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Myofascial release
Muscle stretching
Control
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Myofascial release, Pain, Manual therapy, Muscle stretching, Quality of life

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de Pernambuco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Myofascial release

Muscle Stretching

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Amount of analgesic ingested
Measured by the analgesic diary, wich is filled weekly

Full Information

First Posted
January 7, 2018
Last Updated
March 19, 2019
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT03408496
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
February 16, 2019 (Actual)
Study Completion Date
March 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Myofascial release, Pain, Manual therapy, Muscle stretching, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be allocated in 3 groups. The myofascial release group, muscle stretching group and control group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial release
Arm Type
Experimental
Arm Description
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.
Arm Title
Muscle Stretching
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release
Intervention Description
Manual therapy
Intervention Type
Other
Intervention Name(s)
Muscle stretching
Intervention Description
Muscle stretching
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Medical appointment
Primary Outcome Measure Information:
Title
Pain intensity level change
Description
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
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)
Title
Quality of life score change
Description
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.
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)
Secondary Outcome Measure Information:
Title
Amount of analgesic ingested
Description
Measured by the analgesic diary, wich is filled weekly
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil

12. IPD Sharing Statement

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

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