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

NCT01907711 | Unknown Phase 2 DMC

• 2 other identifiers: AV/ASCOIB. PR - 2725/12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Fatigue Syndrome.; Muscular Diseases.; Cognitive Impairment; Sleep Disturbances; Pain.

Keywords

Acupuncture.; Fatigue syndrome chronic.; Sleep disturbances.; Pain.; Cognitive impairment.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• • Pain scale (McGill) (MPQ)

  one year

• Sleep quality (Pittsburgh) scale (PSQI)

  one year

• Quality of life scale (ST-36)

  one year

• Anxiety and depression scale HAD.

  one year

Study Arms (2)

Sham Acupuncture.

SHAM COMPARATOR

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.

True acupuncture

ACTIVE COMPARATOR

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.

Interventions

Acupuncture. DEVICE

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".

Also known as: Assurance in manufacturing. EN ISO9001., Registration No.: 60007186 DD 0001., Notified under No 0197 to the EC Commission.

Sham Acupuncture.; True acupuncture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospital Vall d'Hebron: lead

Study Sites (2)

HValldhebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

HValldhebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Related 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: 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.

  RESULT

Related Links

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

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Muscular Diseases; Cognitive Dysfunction; Parasomnias; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jimenez Gutierrez, Nurse

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimenez C Gutierrez, Nurse

CONTACT

conxitajg@gmail.com

Alegre J Martín, Doctor

CONTACT

18502jam@comb.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse. Master´s: acupuncture. Master´s: clinical research applied to health sciences

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 25, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

ES (2)