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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408496
• Other study ID #: NSchulze
• Status: Completed
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: March 19, 2019

Study information

• Verified date: September 2018
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 19, 2019
• Est. primary completion date: February 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Myofascial release
Manual therapy
• Muscle stretching
Muscle stretching
• Control
Medical appointment

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Amount of analgesic ingested	Measured by the analgesic diary, wich is filled weekly	Up to 12 weeks