Back to resultsAcunpuncture for Fibromyalgia Syndrome
Primary Purpose
Acupuncture, Fibromyalgia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acupuncture
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of Fibromyalgia
Exclusion Criteria:
coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture Group
Standard Therapy Group
Arm Description
Outcomes
Primary Outcome Measures
Pain Score
Numeric Rating Scale from 0 (absence of pain )to 10 (worst pain )
Secondary Outcome Measures
Full Information
NCT ID
NCT04421521
First Posted
April 28, 2020
Last Updated
June 4, 2020
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT04421521
Brief Title
Acunpuncture for Fibromyalgia Syndrome
Official Title
Acupuncture for Fibromyalgia Syndrome: An Observational Parallel Groups Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture Group
Arm Type
Experimental
Arm Title
Standard Therapy Group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture with disposable needles will be implemented
Primary Outcome Measure Information:
Title
Pain Score
Description
Numeric Rating Scale from 0 (absence of pain )to 10 (worst pain )
Time Frame
28 days after the completion of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of Fibromyalgia
Exclusion Criteria:
coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator
12. IPD Sharing Statement
Learn more about this trial
Acunpuncture for Fibromyalgia Syndrome
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