EUCTR2015-000796-28-ES
Active, not recruiting
Not Applicable
A pilot, single-blind, placebo-controlled study to assess efficacy and safety of interfascial blockade of the painful trapezius muscle in patients with fribromyalgia
Fundacio Clinic per a la Recerca Biomèdica0 sitesJune 15, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trapezius muscle pain in patients with fibromyalgia
- Sponsor
- Fundacio Clinic per a la Recerca Biomèdica
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age 18 or more
- •2\.Patients diagnosed of Fibromyalgia as primary cause of pain, according ACR 1990 criteria
- •3\.Not treated or on stable treatment for the last 3 months
- •4\.Spontaneous continuous pain at the upper trapezius muscle for more than three months with a VAS intensity above 4,
- •5\.Signed Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 60
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\.Any non\-controlled condition or disease (cardiovascular, endocrine, etc)
- •2\.Other neuromuscular, infectious, metabolic or inflammatory diseases.
- •3\.Current anticoagulant therapy or coagulation abnormalities
- •4\.Prior surgery at shoulder or spine level
- •5\.Active vertebral disease (cervical or thoracic)
- •6\.Joint or tendon disease affecting shoulder area
- •7\.Intolerance or hypersensitivity to bupivacaine or other local anaesthetic agents
- •8\.Pregnant or nursing women
- •9\.Skin lesions at the injection site
- •10\.Implantable devices for pain neuromodulation
Outcomes
Primary Outcomes
Not specified
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