Status:
UNKNOWN
Clinical Trial to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With CFS.
Lead Sponsor:
Hospital Vall d'Hebron
Conditions:
Chronic Fatigue Syndrome.
Muscular Diseases.
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional affect holistically to people who have the disease and current management of fatigue, pain, anxiety, depressi...
Detailed Description
Headline Goal. Evaluate the effectiveness of true acupuncture (AV) compared to placebo-acupuncture or sham acupuncture (AS) in improving symptoms of patients diagnosed with CFS. Specific objectives:...
Eligibility Criteria
Inclusion
- Patients must meet each of the following criteria for admission to the study:
- Patients of both sexes.
- Aged between 18 and 70 years.
- Patients diagnosed as having chronic fatigue syndrome according to the diagnostic criteria Fukuda.
- Patients who have previously given their informed consent for participation in the study.
Exclusion
- -Patients who have had prior treatment with acupuncture.
- Pregnant or lactating.
- Women of childbearing potential not using an effective contraceptive method according to medical criteria.
- Terminal clinical condition.
- History of allergy and / or hypersensitivity to the acupuncture needles.
- Patients who are on anticoagulant therapy.
- Use of investigational agents or not registered in the 30 days prior to study entry.
- Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
- Any individual who, in the opinion of the investigator, may not be able to follow instructions or make a good filling of the therapeutic regimen.
- Subjects who do not grant written consent to participate in the study.
- Labor litigation for reasons of participation in the clinical trial of CFS.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01907711
Start Date
February 1 2013
End Date
October 1 2014
Last Update
August 29 2013
Active Locations (2)
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1
HValldhebron
Barcelona, Barcelona, Spain, 08035
2
HValldhebron
Barcelona, Barcelona, Spain, 08035