Acunpuncture for Fibromyalgia Syndrome

NCT ID: NCT04421521

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acupuncture Fibromyalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture Group

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Acupuncture with disposable needles will be implemented

Standard Therapy Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Acupuncture with disposable needles will be implemented

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

clinical diagnosis of Fibromyalgia

Exclusion Criteria

coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2717

Identifier Type: -

Identifier Source: org_study_id

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