Clinical Trial to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With CFS.

Cognitive Impairment Clinical Trial

— AV/AS  

Official title:

Clinical Trial, Randomized, Controlled, Parallel, to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With Chronic Fatigue Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01907711
• Other study ID #: AV/AS
• Secondary ID: COIB. PR - 2725/
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 27, 2013
• Last updated: August 28, 2013
• Start date: February 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2013
• Source: Hospital Vall d'Hebron
• Contact: Jimenez C Gutierrez, Nurse
• Email: conxitajg[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome.
• Cognition Disorders
• Cognitive Impairment
• Dyssomnias
• Fatigue
• Fatigue Syndrome, Chronic
• Muscular Diseases
• Muscular Diseases.
• Pain.
• Parasomnias
• Sleep Disorders
• Sleep Disturbances

Intervention

Device:
• Acupuncture.
Who tried the insertion and manipulation between 8 - 12 needles with guide applied at different points of the body, individually selected and customized, after the insertion, the acupoint stimulation is done through manipulation of de needle sleeve to achieve at each point the sensation known as "De Qi".

Locations

Country	Name	City	State
Spain	HValldhebron	Barcelona
Spain	HValldhebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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: st

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue, asses the scale fatigue FÍS. • Fatigue: Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques	first visit,13 visit, 6 months and 1 year	one year	Yes
Secondary	• Pain scale (McGill) (MPQ)	first visit, 13th visit, 6 months and one year	one year	Yes
Secondary	Sleep quality (Pittsburgh) scale (PSQI)	first visit, 13th visit, 6 months and one year	one year	Yes
Secondary	Quality of life scale (ST-36)	first visit, 13th visit, 6 months and one year	one year	Yes
Secondary	Anxiety and depression scale HAD.	first visit, 13th visit, 6 months and one year	one year	Yes

External Links

•   Valle Hebrón institut de recerca.org. Barcelona. Spain.