NCT04421521

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 9, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

April 28, 2020

Last Update Submit

June 4, 2020

Conditions

AcupunctureFibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Numeric Rating Scale from 0 (absence of pain )to 10 (worst pain )

    28 days after the completion of the treatment

Study Arms (2)

Acupuncture Group

EXPERIMENTAL
Procedure: Acupuncture

Standard Therapy Group

NO INTERVENTION

Interventions

AcupuncturePROCEDURE

Acupuncture with disposable needles will be implemented

Acupuncture Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of Fibromyalgia

You may not qualify if:

  • coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

June 9, 2020

Study Start

July 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

June 9, 2020

Record last verified: 2020-04