- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03408496
Myofascial Release of Physiological Chains and Muscle Stretching in Patients With Fibromyalgia
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50740-560
- Universidade Federal de Pernambuco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
Medical appointment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of analgesic ingested
Time Frame: Up to 12 weeks
|
Measured by the analgesic diary, wich is filled weekly
|
Up to 12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSchulze
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibromyalgia
-
University of AberdeenCompletedFibromyalgia | Fibromyalgia, Primary | Fibromyalgia, SecondaryUnited Kingdom
-
Eli Lilly and CompanyCompletedFibromyalgia, Primary | Fibromyalgia, SecondaryMexico
-
Rasmia ElgoharyNot yet recruiting
-
Tel-Aviv Sourasky Medical CenterCompletedFibromyalgia (FM)Israel
-
Yousra Hisham Abdel FattahCompletedFibromyalgia, PrimaryEgypt
-
Forest LaboratoriesCypress Bioscience, Inc.TerminatedPrimary FibromyalgiaUnited States
-
Universidade Federal do Rio Grande do NorteCompleted
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
University of ManitobaCompleted
Clinical Trials on Myofascial release
-
Cardenal Herrera UniversityCompletedGastroesophageal Reflux DiseaseSpain
-
Hacettepe UniversityActive, not recruitingParkinson Disease | Movement Disorders | Exercise Therapy | Myofascial ReleaseTurkey
-
Riphah International UniversityCompleted
-
Yeditepe UniversityNot yet recruiting
-
Akdeniz UniversityPamukkale UniversityCompletedInvestigation of Acute Effects of Myofascial Trigger Point Release in Women With Chronic Pelvic PainPelvic Pain | Myofascial Trigger Point Pain | Pelvic Floor; RelaxationTurkey
-
Dokuz Eylul UniversityRecruitingAthletes | VolleyballTurkey
-
Université de SherbrookeCompleted
-
Riphah International UniversityRecruitingLow Back PainPakistan
-
Istanbul University - Cerrahpasa (IUC)RecruitingMobility Limitation | Pectoralis Minor Muscle Tension | Muscle Shortness | Forward Scapular Posture | Rounded Shoulder PostureTurkey
-
Istanbul Medipol University HospitalRecruitingLow Back Pain | Temporomandibular Joint DisorderTurkey