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NCT04421521 Clinical Trial

Acunpuncture for Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:
Acupuncture for Fibromyalgia Syndrome: An Observational Parallel Groups Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04421521
Other study ID # 2717
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date May 1, 2021

Study information
Verified date April 2020
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 44
Est. completion date May 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

clinical diagnosis of Fibromyalgia

Exclusion Criteria:

coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Acupuncture
Acupuncture with disposable needles will be implemented

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Score Numeric Rating Scale from 0 (absence of pain )to 10 (worst pain ) 28 days after the completion of the treatment
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