We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acunpuncture for Fibromyalgia Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421521
Recruitment Status : Unknown
Verified April 2020 by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Recruitment status was:  Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
patients suffering from fibromyalgia syndrome according to the criteria of the American College of Rheumatology 2010 will be enrolled. All fibromyalgic patients will be subjected to a further ambulatory visit and if an energy deficiency in the Liver and Spleen Meridians will be identified, according to the Traditional Chinese Medicine rules, acupuncture will be planned. If not, a standard therapy with analgesic drugs will be started. Acupuncture treatment will consist of six weekly sessions. Tricyclic antidepressants, anti-epileptic drugs, selective serotonin reuptake inhibitors and opioids will be used as standard strategy. Pain Scores and Fatigue Impact Scale will be assessed before any treatment and after a 28 days follow-up.

Condition or disease Intervention/treatment Phase
Acupuncture Fibromyalgia Procedure: Acupuncture Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Fibromyalgia Syndrome: An Observational Parallel Groups Study
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Acupuncture Group Procedure: Acupuncture
Acupuncture with disposable needles will be implemented
No Intervention: Standard Therapy Group


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pain Score [ Time Frame: 28 days after the completion of the treatment ]
    Numeric Rating Scale from 0 (absence of pain )to 10 (worst pain )


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

clinical diagnosis of Fibromyalgia

Exclusion Criteria:

coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04421521    
Other Study ID Numbers: 2717
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases