- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01189994
Trial of Acupuncture in the Treatment of Fibromyalgia
September 3, 2010 updated by: Santa Casa da Misericordia do Rio de Janeiro Hospital
Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia
Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep disturbances and depression.
It affects population at a socioeconomically active age and represents a burden for the patients and the health care system due to its personal and functional implications.
At this moment, there is no completely effective treatment for fibromyalgia, and acupuncture has been a promising alternative.
This trial aims to evaluate if addition of acupuncture to standard care represents an improvement in comparison with standard care only.
Thus, patients enrolled in this trial will be randomly allocated into one of two groups: group A, who besides standard treatment will receive 12 sessions of acupuncture; and group B, who will receive standard care with monthly orientation sessions for the same period.
Patients will be evaluated at baseline, after completion of acupuncture treatment or orientation, and after an additional 12-week follow up.
Evaluation will be based on diaries of pain and medication, and standard scales of pain, quality of life and disability.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fernando P de Farias, MD, PhD
- Phone Number: (+5521) 9263-8673
- Email: fernandopfarias@gmail.com
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil
- Recruiting
- Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro
-
Contact:
- Fernando P de Farias, MD, PhD
- Phone Number: (+5521) 9263-8673
- Email: fernandopfarias@gmail.com
-
Principal Investigator:
- Fernando P de Farias, MD, PhD
-
Sub-Investigator:
- Washington Bianchi, MD
-
Sub-Investigator:
- Orlando J Goncalves Filho, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American College of Rheumatology criteria for fibromyalgia
- elementary school
- drug treatment for at least 30 days (if any)
Exclusion Criteria:
- disabling mental condition
- other rheumatic conditions
- other chronic medical conditions with musculoskeletal symptoms
- pregnancy
- conditions that impair walking
- conditions that impair weekly consultations
- acupuncture treatment in the twelve-month period prior to enrollment
- diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture
Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions
|
Needling of acupoints, some of them receiving electrostimulation
|
Active Comparator: Orientation
Patients will receive standard care only, coming to three monthly orientation sessions
|
Orientation sessions focusing in fibromyalgia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fibromyalgia Impact Questionnaire (FIQ) score
Time Frame: Twelve weeks from baseline
|
Twelve weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weekly Likert scale in pain diary
Time Frame: Twelve weeks from baseline
|
Twelve weeks from baseline
|
Visual Analog Scale (VAS) for pain
Time Frame: Twelve weeks from baseline
|
Twelve weeks from baseline
|
Short Form 36 (SF-36) score for quality of life
Time Frame: Twelve weeks from baseline
|
Twelve weeks from baseline
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Time Frame: Twelve weeks from baseline
|
Twelve weeks from baseline
|
Hospital Anxiety and Depression (HAD) Scale
Time Frame: Twelve weeks from baseline
|
Twelve weeks from baseline
|
Fibromyalgia Impact Questionnaire (FIQ) score
Time Frame: Twenty-four weeks from baseline
|
Twenty-four weeks from baseline
|
Weekly Likert scale in pain diary
Time Frame: Twenty-four weeks from baseline
|
Twenty-four weeks from baseline
|
Visual Analog Scale (VAS) for pain
Time Frame: Twenty-four weeks from baseline
|
Twenty-four weeks from baseline
|
Short Form 36 (SF-36) score for quality of life
Time Frame: Twenty-four weeks from baseline
|
Twenty-four weeks from baseline
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Time Frame: Twenty-four weeks from baseline
|
Twenty-four weeks from baseline
|
Hospital Anxiety and Depression (HAD) Scale
Time Frame: Twenty-four weeks from baseline
|
Twenty-four weeks from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fernando P de Farias, MD, PhD, Santa Casa da Misericordia do Rio de Janeiro Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Anticipated)
September 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
August 25, 2010
First Submitted That Met QC Criteria
August 26, 2010
First Posted (Estimate)
August 27, 2010
Study Record Updates
Last Update Posted (Estimate)
September 6, 2010
Last Update Submitted That Met QC Criteria
September 3, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCMRJH-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibromyalgia
-
University of AberdeenCompletedFibromyalgia | Fibromyalgia, Primary | Fibromyalgia, SecondaryUnited Kingdom
-
Eli Lilly and CompanyCompletedFibromyalgia, Primary | Fibromyalgia, SecondaryMexico
-
Rasmia ElgoharyNot yet recruiting
-
Tel-Aviv Sourasky Medical CenterCompletedFibromyalgia (FM)Israel
-
Yousra Hisham Abdel FattahCompletedFibromyalgia, PrimaryEgypt
-
Forest LaboratoriesCypress Bioscience, Inc.TerminatedPrimary FibromyalgiaUnited States
-
Universidade Federal do Rio Grande do NorteCompleted
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
University of ManitobaCompleted
Clinical Trials on Acupuncture
-
University of ZurichCharite University, Berlin, Germany; First Teaching Hospital of Tianjin University...CompletedExperimental Dental PainSwitzerland
-
Federal University of São PauloCompleted
-
University of MichiganMassachusetts General Hospital; National Center for Complementary and Integrative...Completed
-
University of SkövdeCompleted
-
National Research Centre of Complementary and Alternative...Norwegian Acupuncture CollegeUnknown
-
Chengdu University of Traditional Chinese MedicineChongqing Medical University; Hunan University of Traditional Chinese MedicineCompletedFunctional Dyspepsia | Postprandial Distress SyndromeChina
-
Chang Gung Memorial HospitalRecruitingIntracranial HemorrhagesTaiwan
-
University Medicine GreifswaldRecruitingGagging During Transesophageal EchocardiographyGermany
-
Huazhong University of Science and TechnologyThe University of Hong Kong; Heilongjiang University of Chinese Medicine; Hubei...CompletedPolycystic Ovary SyndromeChina
-
China Medical University HospitalNot yet recruiting