FibromyalgiaEarly Phase 1NCT00379496
Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
A Early Phase 1 study testing Antidepressants and acupuncture in people with Fibromyalgia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the effect of acupuncture as a treatment for this condition. Fifty-eight women diagnosed with fibromyalgia were randomly allocated to two groups. One group received acupuncture (n=34) twice a week for 20 sessions in addition to tricyclic antidepressants and exercises. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Antidepressants and acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2000to May 2002
- Phase
- Early Phase 1
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients had to report moderate to severe pain intensity (VAS > four), and they had to be using antidepressant medication in an analgesic dose (between 12.5mg/day and 75mg/day).
Who cannot join
- Patients were excluded in the case of severe psychiatric disease, the presence of neurological deficits, cardiac disease or glaucoma, and treatment with acupuncture within one year prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403010
About this study
Official title: A Randomized Controlled Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
The aim of this study was to evaluate the effect of acupuncture as a treatment for this condition. Fifty-eight women diagnosed with fibromyalgia were randomly allocated to two groups. One group received acupuncture (n=34) twice a week for 20 sessions in addition to tricyclic antidepressants and exercises. The control group (n=24) received only tricyclic antidepressants and exercises. A blinded assessor evaluated patients' pain using visual analog scale (VAS), tender points number (TePsN) and myalgic index (MI). The same assessor also evaluated quality of life (QoL) using SF-36. These evaluations were done prior to treatments, at the end of the 20 sessions, and again at six months, one year and two years after the first evaluation. At the end of the 20 sessions, patients who had received acupuncture were significantly better than those who had not in all measures of pain (VAS, TePsN, MI) and in five subscales of SF-36. After six months, the acupuncture group was significantly better than the control group in some measures of pain (TePsN and MI) and in three subscales of SF-36. After one year, the acupuncture group showed significant advantage in only one subscale of SF-36; at two years there were no significant differences between the two groups on all outcome measures. The addition of acupuncture to usual treatment for fibromyalgia is beneficial for pain and quality of life, but only in first six months.
Read the detailed description
Fibromyalgia is a diffuse musculoskeletal pain syndrome with multiple tender points which are widely and symmetrically distributed throughout the body. The main symptom is widespread musculoskeletal pain, lasting longer than three months, which is associated with chronic fatigue, cognitive dysfunction, sleep disorder, morning stiffness, anxiety and depression. The etiology of fibromyalgia remains unknown.
In Brazil, fibromyalgia is estimated to affect two-and-half percent of the population . This incidence is similar to other countries .Acupuncture, which involves inserting needles at specific points on the patient's skin, is one of the oldest forms of therapy and is widely practiced in the United States. Each year about one million Americans undergo acupuncture treatments, mainly to relieve pain caused by a variety of ailments . A consensus statement from the U.S. National Institutes of Health (NIH) concluded that acupuncture may be useful as an adjunct treatment or may be an acceptable alternative treatment in a comprehensive management program for fibromyalgia patients (NIH Consensus Conference, 1998.In Brazil, there is increased interest in acupuncture; in 1995, a federal law established that the procedure can only be performed by physicians.
Systematic reviews looking at the effectiveness of acupuncture for fibromyalgia have found a limited amount of high quality scientific studies. These reviews concluded that acupuncture was more effective than sham (placebo) acupuncture in improving symptoms of fibromyalgia. There is a need for acupuncture trials that include a large sample size of patients with similar and well-defined pain conditions. Such trials should utilize standardized and well-described acupuncture stimuli. These should be placed effectively in the skin in accordance with classical Chinese experience and utilizing unequivocal primary outcome measures for the effect.
- Conditions
- Fibromyalgia
- Being tested
- Antidepressants, acupuncture
- Keywords
- Fibromyalgia, Acupuncture, Randomized study
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantsProcedure or surgery
acupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS(Visual Analogical Scale)
SF-36(Short Form 36)
Myalgic Index
Number of tender points
Secondary outcomes (4)
VAS(Visual Analogical Scale)(5 times)
SF-36(Short Form 36)(5 times)
Myalgic Index(5 times)
Number of tender points(5 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startApr 2000
- Study completionMay 2002
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 58 participants
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rosa A Targino, MD, Principal investigator, University of Sao Paulo-School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379496
- Sponsor's protocol ID
- 843/99
- Status last verified
- Sep 2006
- First submitted
- 21 Sep 2006
- Last updated
- 22 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
- ClinicalTrials.gov ID
- NCT00379496
- Acronym / sponsor ID
- 843/99
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Acupuncture, Randomized study
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2000
- Study completion
- May 2002
- First posted
- 22 Sep 2006 (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.
The aim of this study was to evaluate the effect of acupuncture as a treatment for this condition. Fifty-eight women diagnosed with fibromyalgia were randomly allocated to two groups. One group received acupuncture (n=34) twice a week for 20 sessions in addition to tricyclic antidepressants and exercises. The control group (n=24) received only tricyclic antidepressants and exercises. A blinded assessor evaluated patients' pain using visual analog scale (VAS), tender points number (TePsN) and myalgic index (MI). The same assessor also evaluated quality of life (QoL) using SF-36. These evaluations were done prior to treatments, at the end of the 20 sessions, and again at six months, one year and two years after the first evaluation. At the end of the 20 sessions, patients who had received acupuncture were significantly better than those who had not in all measures of pain (VAS, TePsN, MI) and in five subscales of SF-36. After six months, the acupuncture group was significantly better than the control group in some measures of pain (TePsN and MI) and in three subscales of SF-36. After one year, the acupuncture group showed significant advantage in only one subscale of SF-36; at two years there were no significant differences between the two groups on all outcome measures. The addition of acupuncture to usual treatment for fibromyalgia is beneficial for pain and quality of life, but only in first six months.
Detailed description
Fibromyalgia is a diffuse musculoskeletal pain syndrome with multiple tender points which are widely and symmetrically distributed throughout the body. The main symptom is widespread musculoskeletal pain, lasting longer than three months, which is associated with chronic fatigue, cognitive dysfunction, sleep disorder, morning stiffness, anxiety and depression. The etiology of fibromyalgia remains unknown.
In Brazil, fibromyalgia is estimated to affect two-and-half percent of the population . This incidence is similar to other countries .Acupuncture, which involves inserting needles at specific points on the patient's skin, is one of the oldest forms of therapy and is widely practiced in the United States. Each year about one million Americans undergo acupuncture treatments, mainly to relieve pain caused by a variety of ailments . A consensus statement from the U.S. National Institutes of Health (NIH) concluded that acupuncture may be useful as an adjunct treatment or may be an acceptable alternative treatment in a comprehensive management program for fibromyalgia patients (NIH Consensus Conference, 1998.In Brazil, there is increased interest in acupuncture; in 1995, a federal law established that the procedure can only be performed by physicians.
Systematic reviews looking at the effectiveness of acupuncture for fibromyalgia have found a limited amount of high quality scientific studies. These reviews concluded that acupuncture was more effective than sham (placebo) acupuncture in improving symptoms of fibromyalgia. There is a need for acupuncture trials that include a large sample size of patients with similar and well-defined pain conditions. Such trials should utilize standardized and well-described acupuncture stimuli. These should be placed effectively in the skin in accordance with classical Chinese experience and utilizing unequivocal primary outcome measures for the effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients had to report moderate to severe pain intensity (VAS > four), and they had to be using antidepressant medication in an analgesic dose (between 12.5mg/day and 75mg/day).
Key exclusion criteria (1 listed)
- Patients were excluded in the case of severe psychiatric disease, the presence of neurological deficits, cardiac disease or glaucoma, and treatment with acupuncture within one year prior to the start of the study.
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 |
|---|---|---|
| Antidepressants | Procedure or surgery | – |
| acupuncture | Procedure or surgery | – |
Primary outcome
VAS(Visual Analogical Scale)
SF-36(Short Form 36)
Myalgic Index
Number of tender points
4 secondary outcomes
VAS(Visual Analogical Scale)(5 times)
SF-36(Short Form 36)(5 times)
Myalgic Index(5 times)
Number of tender points(5 times)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2006.
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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.
Rosa A Targino, MD principal investigator
University of Sao Paulo-School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Antidepressants and acupuncture in people with Fibromyalgia, run by University of Sao Paulo 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Sep 2006. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS(Visual Analogical Scale). The study lists 4 primary outcomes in all. 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 22 Sep 2006.