FibromyalgiaNCT01189994
Trial of Acupuncture in the Treatment of Fibromyalgia
A study testing Acupuncture and Orientation in people with Fibromyalgia and Diffuse Myofascial Pain Syndrome, run by Santa Casa da Misericordia do Rio de Janeiro Hospital at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fibromyalgia, Diffuse Myofascial Pain Syndrome, Fibromyalgia-Fibromyositis Syndrome
- What is being tested?
- Acupuncture and Orientation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American College of Rheumatology criteria for fibromyalgia
- elementary school
- drug treatment for at least 30 days (if any)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
Fernando P de Farias, MD, PhD, (+5521) 9263-8673, fernandopfarias@gmail.com
Fernando P de Farias, MD, PhD
About this study
Official title: 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.
- Conditions
- Fibromyalgia, Diffuse Myofascial Pain Syndrome, Fibromyalgia-Fibromyositis Syndrome, Fibromyositis-Fibromyalgia Syndrome, Myofascial Pain Syndrome, Diffuse
- Being tested
- Acupuncture, Orientation
- Keywords
- Fibromyalgia, Acupuncture, Randomized Controlled Trial, Pain, Quality of Life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Needling of acupoints, some of them receiving electrostimulation
OrientationBehavioural
Orientation sessions focusing in fibromyalgia
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions Receives: Procedure: Acupuncture |
| Orientation | Active comparator | Patients will receive standard care only, coming to three monthly orientation sessions Receives: Behavioral: Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ) score
Measured: Twelve weeks from baseline
Secondary outcomes (11)
Weekly Likert scale in pain diary
Measured: Twelve weeks from baseline
Visual Analog Scale (VAS) for pain
Measured: Twelve weeks from baseline
Short Form 36 (SF-36) score for quality of life
Measured: Twelve weeks from baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Measured: Twelve weeks from baseline
Hospital Anxiety and Depression (HAD) Scale
Measured: Twelve weeks from baseline
Fibromyalgia Impact Questionnaire (FIQ) score
Measured: Twenty-four weeks from baseline
Weekly Likert scale in pain diary
Measured: Twenty-four weeks from baseline
Visual Analog Scale (VAS) for pain
Measured: Twenty-four weeks from baseline
Short Form 36 (SF-36) score for quality of life
Measured: Twenty-four weeks from baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Measured: Twenty-four weeks from baseline
Hospital Anxiety and Depression (HAD) Scale
Measured: Twenty-four weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santa Casa da Misericordia do Rio de Janeiro Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fernando P de Farias, MD, PhD, Principal investigator, Santa Casa da Misericordia do Rio de Janeiro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189994
- Sponsor's protocol ID
- SCMRJH-001
- Status last verified
- Sep 2010
- First submitted
- 25 Aug 2010
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT01189994
- Acronym / sponsor ID
- SCMRJH-001
- Conditions
- Fibromyalgia, Diffuse Myofascial Pain Syndrome, Fibromyalgia-Fibromyositis Syndrome, Fibromyositis-Fibromyalgia Syndrome, Myofascial Pain Syndrome, Diffuse
- Keywords
- Fibromyalgia, Acupuncture, Randomized Controlled Trial, Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Santa Casa da Misericordia do Rio de Janeiro HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupuncturePatients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions |
| Orientation | Active comparator | Behavioral: OrientationPatients will receive standard care only, coming to three monthly orientation sessions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American College of Rheumatology criteria for fibromyalgia
- elementary school
- drug treatment for at least 30 days (if any)
Key exclusion criteria (8 listed)
- disabling mental condition
- other rheumatic conditions
- other chronic medical conditions with musculoskeletal symptoms
- pregnancy
- conditions that impair walking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureNeedling of acupoints, some of them receiving electrostimulation | Procedure or surgery | Acupuncture |
| OrientationOrientation sessions focusing in fibromyalgia | Behavioural | Orientation |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Twelve weeks from baseline
11 secondary outcomes
Weekly Likert scale in pain diary
Time frame: Twelve weeks from baseline
Visual Analog Scale (VAS) for pain
Time frame: Twelve weeks from baseline
Short Form 36 (SF-36) score for quality of life
Time frame: Twelve weeks from baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Time frame: Twelve weeks from baseline
Hospital Anxiety and Depression (HAD) Scale
Time frame: Twelve weeks from baseline
Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Twenty-four weeks from baseline
Weekly Likert scale in pain diary
Time frame: Twenty-four weeks from baseline
Visual Analog Scale (VAS) for pain
Time frame: Twenty-four weeks from baseline
Short Form 36 (SF-36) score for quality of life
Time frame: Twenty-four weeks from baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Time frame: Twenty-four weeks from baseline
Hospital Anxiety and Depression (HAD) Scale
Time frame: Twenty-four weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando P de Farias, MD, PhD principal investigator
Santa Casa da Misericordia do Rio de Janeiro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Orientation in people with Fibromyalgia and Diffuse Myofascial Pain Syndrome, run by Santa Casa da Misericordia do Rio de Janeiro Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando P de Farias, MD, PhD ((+5521) 9263-8673, fernandopfarias@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ) score (time frame: Twelve weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2010.