Clinical trial NCT01907711: Clinical Trial to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With CFS.
Official title: Clinical Trial, Randomized, Controlled, Parallel, to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With Chronic Fatigue Syndrome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Fatigue Syndrome.
Muscular Diseases.
Cognitive Impairment
Sleep Disturbances
Pain.
Keywords: Acupuncture.
Fatigue syndrome chronic.
Sleep disturbances.
Pain.
Cognitive impairment.
Lead sponsor: Hospital Vall d'Hebron
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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, depression and sleep disturbances present in this clinical entity is unsatisfactory.

Hypothesis:

The hypothesis of this essay is to contrast that acupuncture is more useful than placebo.

The investigators suggest the use of a clinical study protocol (PEC), randomized, placebo-controlled, acupuncture technique, aimed at increasing the patient's sense of well-being, relief of pain and stiffness, acupuncture is effective to reduce fatigue, anxiety, depression and sleep disorders in patients diagnosed with CFS.

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:

* 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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Fatigue, asses the scale fatigue FÍS. • Fatigue: Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques
timeFrame: one year
Secondary outcomes:
measure: • Pain scale (McGill) (MPQ)
timeFrame: one year
measure: Sleep quality (Pittsburgh) scale (PSQI)
timeFrame: one year
measure: Quality of life scale (ST-36)
timeFrame: one year
measure: Anxiety and depression scale HAD.
timeFrame: one year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: HValldhebron
city: Barcelona
country: Spain
facility: HValldhebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Jimenez Gutierrez, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vas J, Mendez C, Perea-Milla E. Acupuncture vs Streitberger needle in knee osteoarthritis - an RCT. BMJ 2004;329:1216-219. Vas J, Modesto M, Aguilar I, Santos-Rey K, Benitez- Parejo N, Rivas-Ruiz F: Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial. Trials 2011;12:59. Wang T, Zhan Q, Xue X, Yeung A. A systematic review of acunpunture and Moxibustion treatment for chronic fatigue syndrome in China. Am J Chin Med 2008;36:1-24. Wang JJ, Song YJ, Wu ZC, Chu XO, Wang XH, Wang XJ, et al. A meta analysis on randomized controlled trials of acupuncture treatment of chronic fatigue syndrome. Zhen Ci Yan Jiu 2009;34:421-8.