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:
To assess whether, in patients diagnosed with Chronic Fatigue Syndrome, AV treatment,
compared to AS, is associated with a reduction in fatigue as measured by the scale FIS
(Fatigue impact Scale).
Check the reduction of pain in patients diagnosed with CFS, following treatment with AS
versus AV as measured by the McGill.
To verify the decrease in the use of analgesics in patients diagnosed with CFS, after
treatment with the AV versus AS, by counting these drugs.
Evaluate reducing anxiety in patients diagnosed with CFS, following treatment with AS AV
against measured by HAD scale.
Assess whether, in patients diagnosed with CFS, treatment with AV compared to AS, is
associated with a reduction in depressive symptoms, as measured by the HAD scale.
To assess the improvement in sleep quality in patients diagnosed with CFS, after
treatment with AV compared to the AS, as measured by the Pittsburgh scale.
Check the quality improvement of health-related life (HRQOL) in patients diagnosed with
CFS, after treatment with AV compared to the AS, as measured by the SF-36 (Short
Form-36).
Methodology.
Design.
Pilot clinical trial randomized, parallel group, placebo-controlled simulated acupuncture,
single-center, prospective, patient and assessor blind. 1:1 randomized trial, the principal
investigator unknown randomization to the time the patient is randomized.
Primary endpoint. Scores on the fatigue impact scale (FIS) after treatment with two
acupuncture techniques.
Study population and total number of patients. After signing the informed consent, we
included 60 patients diagnosed with CFS, 30 in the intervention group (IG) of real
acupuncture and 30 in the control group (CG) of sham acupuncture, applying an individualized
treatment plan customized according energy assessment of each patient.
Duration of treatment. 4 months.
Relevance.
This pilot study can demonstrate the effectiveness of acupuncture as a treatment for the
symptoms of CFS. The reduction in fatigue, anxiety, depression, pain and reduction in the
intake of analgesics with improved sleep quality, after treatment with real acupuncture
technique, i results in increased quality of life for the patient suffering from CFS.
Inclusion criteria.
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 criteria.
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 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.