NCT03408496

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
16 days until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2019

Completed
Last Updated

March 21, 2019

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

January 7, 2018

Last Update Submit

March 19, 2019

Conditions

Keywords

Myofascial releasePainManual therapyMuscle stretchingQuality of life

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

EXPERIMENTAL

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

Muscle Stretching

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Manual therapy

Myofascial release

Muscle stretching

Muscle Stretching
ControlOTHER

Medical appointment

Control

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Myofascial Release TherapyMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be allocated in 3 groups. The myofascial release group, muscle stretching group and control group.
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

Locations