Clinical Trial to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With CFS. (AV/AS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Hospital Vall d'Hebron
Sponsor:
Information provided by (Responsible Party):
Conchita Jimenez Gutierrez, Hospital Vall d'Hebron
ClinicalTrials.gov Identifier:
NCT01907711
First received: June 27, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Chronic Fatigue Syndrome.
Muscular Diseases.
Cognitive Impairment
Sleep Disturbances
Pain.
Device: Acupuncture.
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Clinical Trial, Randomized, Controlled, Parallel, to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With Chronic Fatigue Syndrome.

Resource links provided by NLM:


Further study details as provided by Hospital Vall d'Hebron:

Primary Outcome Measures:
  • Fatigue, asses the scale fatigue FÍS. • Fatigue: Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    first visit,13 visit, 6 months and 1 year


Secondary Outcome Measures:
  • • Pain scale (McGill) (MPQ) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    first visit, 13th visit, 6 months and one year

  • Sleep quality (Pittsburgh) scale (PSQI) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    first visit, 13th visit, 6 months and one year

  • Quality of life scale (ST-36) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    first visit, 13th visit, 6 months and one year

  • Anxiety and depression scale HAD. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    first visit, 13th visit, 6 months and one year


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham Acupuncture.
That through the center of the guide tube is inserted blunt rod, producing the sensation of a prick in each of the eight points that are not acupuncture points. No intervention is a completely inert as it involves some type of peripheral stimulus, but the technique is closer to a placebo and offers interesting option from a methodologic al point of view showing and ability to mimic real acupuncture The points are not used acupuncture points but are fictional points. The patient should remáis lying prone during the 20 minutes of the session, so the placebo technique remains hidden. Every five minutes the acupuncturist will repeat the action in the corresponding eigh points.
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".
Other Names:
  • Assurance in manufacturing. EN ISO9001.
  • Registration No.: 60007186 DD 0001.
  • Notified under No 0197 to the EC Commission.
Active Comparator: True acupuncture
The AV is an energy balance treatment with the aim of restoring health and well-being of the patient. Since each patient may have moré than three diagnoses of Traditional Chinese Medicine, will undertake a Major effort of synthesis of acupuncture points for treatment in a session, use the AV 8 - 12 needles, are held in place for 20 minutes with bidirectional rotation of the sleeve needle for one minute every five minutes (a total of four rotations for session). And in the AS 8 tube rod guides with blunt tip for 20 minutes. The same time be devoted to the patients in each treatment group similar, the time requested for the period of pre and post-treatment will be identical in all cases.
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".
Other Names:
  • Assurance in manufacturing. EN ISO9001.
  • Registration No.: 60007186 DD 0001.
  • Notified under No 0197 to the EC Commission.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907711

Contacts
Contact: Jimenez C Gutierrez, Nurse conxitajg@gmail.com
Contact: Alegre J Martín, Doctor 18502jam@comb.es

Locations
Spain
HValldhebron Recruiting
Barcelona, Spain, 08035
Contact: Jiménez C Gutiérrez, Nurse       conxitajg@gmail.com   
Contact: Alegre J Martín, Doctor       18502jam@gmail.com   
Principal Investigator: Jimenez C Gutierrez, Nurse         
HValldhebron Recruiting
Barcelona, Spain, 08035
Contact: Jimenez C Gutierrez, Nurse       conxitajg@gmail.com   
Contact: Alegre J Martin, Doctor         
Sub-Investigator: Caparrós M Granados, Nurse         
Sub-Investigator: Domingo C Gómez, Doctor         
Sub-Investigator: Charles JM Vallcanera, Phisiotherap         
Sub-Investigator: Saez N Francas, Doctor         
Sub-Investigator: Aliste L Sanchez, Stadistique         
Sub-Investigator: Alegre J Martin, Doctor         
Sponsors and Collaborators
Hospital Vall d'Hebron
Investigators
Principal Investigator: Jimenez Gutierrez, Nurse Hospital Vall d'Hebron
  More Information

Additional Information:
No publications provided

Responsible Party: Conchita Jimenez Gutierrez, Nurse. Master´s: acupuncture. Master´s: clinical research applied to health sciences, Hospital Vall d'Hebron
ClinicalTrials.gov Identifier: NCT01907711     History of Changes
Other Study ID Numbers: AV/AS, COIB. PR - 2725/12
Study First Received: June 27, 2013
Last Updated: August 28, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Vall d'Hebron:
Acupuncture.
Fatigue syndrome chronic.
Sleep disturbances.
Pain.
Cognitive impairment.

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Syndrome
Cognition Disorders
Fatigue
Dyssomnias
Sleep Disorders
Parasomnias
Muscular Diseases
Disease
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Virus Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 18, 2014