FibromyalgiaNCT01163409
Exercise, Acupuncture and Fibromyalgia
A study testing exercise training, acupuncture and Exercise, Acupuncture and Fibromyalgia in people with Fibromyalgia and Juvenile, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Fibromyalgia, Juvenile
- What is being tested?
- exercise training, acupuncture and Exercise, Acupuncture and Fibromyalgia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2010to Jun 2014
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Juvenile fibromyalgia diagnosis
- Age between ten to seventeen years and eleven months
Who cannot join
- Previous treatment with acupuncture;
- Treatment with psychotherapy, exercise training, use of antidepressant and anti-inflammatory drugs in the last month;
- Inflammatory diseases, hypothyroidism and hyperthyroidism
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Magda Maria Maia
São Paulo, São Paulo, 5511
University of Sao Paulo
São Paulo, São Paulo, 5511
About this study
Official title: Acupuncture and Physical Activity in Patients With Fibromyalgia
Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, who just get guidance for physical activity.
Read the detailed description
Fibromyalgia syndrome is a chronic musculoskeletal pain of unknown etiology. It is characterized by diffuse musculoskeletal pain or painful specific sites, usually accompanied by sleep disorders, fatigue, morning stiffness, chronic headaches, mental disorders and functional bowel. The diagnosis is essentially clinical, with no abnormal laboratory and radiological features Physical exercises are part of the treatment of fibromyalgia, but does not report studies in children. In general children with fibromyalgia are encouraged to a multidisciplinary treatment including medication, family education and child graduated aerobic exercise, psychotherapy, interventions to reduce pain, stress and improve sleep quality. To date no studies in medical literature with the use of acupuncture and supervised physical activity in juvenile fibromyalgia.
The significant sample of this disease, our recent publications in this research and the lack of systematic study of physical activity and acupuncture have stimulated this research. Assess pain reduction and improvement in quality of life in children and adolescents with juvenile fibromyalgia.
- Conditions
- Fibromyalgia, Juvenile
- Being tested
- exercise training, acupuncture, Exercise, Acupuncture and Fibromyalgia
- Keywords
- juvenile fibromyalgia, acupuncture, exercise training
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingProcedure or surgery
Also called Multidisciplinary treatment including medication, Family education, Psychotherapy, Interventions to reduce pain
exercise training comprises aerobic and strength training
acupunctureProcedure or surgery
Also called Systematic study of physical activity and acupuncture have stimulated
acupuncture involves two sessions per week, during 14 weeks.
Exercise, Acupuncture and FibromyalgiaProcedure or surgery
Also called Assess pain reduction, Improvement in quality of life in children and adolescents, Compare four treatment groups
Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, we just get guidance for physical activity.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | will be made with classic acupuncture needling in traditional points, surpassing the skin Receives: Procedure: acupuncture; Procedure: Exercise, Acupuncture and Fibromyalgia |
| sham acupuncture | Experimental | sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points. Receives: Procedure: Exercise, Acupuncture and Fibromyalgia |
| exercise training resistance and aerobic | Experimental | Aerobic exercise for 1 hour and resistance exercises for major muscle groups. Receives: Procedure: exercise training; Procedure: Exercise, Acupuncture and Fibromyalgia |
| healthy lifestyle | No intervention | Group 4 - will be the control group who receive follow-up and recommendation for physical activity, but without any intervention supervised. Receives: Procedure: Exercise, Acupuncture and Fibromyalgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Clinical evaluation of pain is made by a general questionnaire for pain and overall evaluation of the patient / family and professional by the Visual Analogue Scale. There will be pain as described in 18 points for fibromyalgia, using as instrument the pressure algiômetro Fischer, settling myalgic index.
Measured: 14 weeks
Secondary outcomes (2)
quality of life
Functional assessment of quality of life will be made by the Childhood Health Assessment Questionnaire (CHAQ) of pediatric Peds QL questionnaire that will be answered by the patients and their parents in age groups: 9-12 years and 13-18 years.
Measured: 14 weeks
strength
will be assessed by means of 1-RM test
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2014 (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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Clóvis AA Silva, M.D, Ph.D, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163409
- Sponsor's protocol ID
- exercisefibro
- Status last verified
- Jun 2010
- First submitted
- 9 Jun 2010
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Physical Activity in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01163409
- Acronym / sponsor ID
- exercisefibro
- Conditions
- Fibromyalgia, Juvenile
- Keywords
- juvenile fibromyalgia, acupuncture, exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 15 Jul 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.
Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, who just get guidance for physical activity.
Detailed description
Fibromyalgia syndrome is a chronic musculoskeletal pain of unknown etiology. It is characterized by diffuse musculoskeletal pain or painful specific sites, usually accompanied by sleep disorders, fatigue, morning stiffness, chronic headaches, mental disorders and functional bowel. The diagnosis is essentially clinical, with no abnormal laboratory and radiological features Physical exercises are part of the treatment of fibromyalgia, but does not report studies in children. In general children with fibromyalgia are encouraged to a multidisciplinary treatment including medication, family education and child graduated aerobic exercise, psychotherapy, interventions to reduce pain, stress and improve sleep quality. To date no studies in medical literature with the use of acupuncture and supervised physical activity in juvenile fibromyalgia.
The significant sample of this disease, our recent publications in this research and the lack of systematic study of physical activity and acupuncture have stimulated this research. Assess pain reduction and improvement in quality of life in children and adolescents with juvenile fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Procedure: acupuncture, Procedure: Exercise, Acupuncture and Fibromyalgiawill be made with classic acupuncture needling in traditional points, surpassing the skin |
| sham acupuncture | Experimental | Procedure: Exercise, Acupuncture and Fibromyalgiasham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points. |
| exercise training resistance and aerobic | Experimental | Procedure: exercise training, Procedure: Exercise, Acupuncture and FibromyalgiaAerobic exercise for 1 hour and resistance exercises for major muscle groups. |
| healthy lifestyle | No intervention | Procedure: Exercise, Acupuncture and FibromyalgiaGroup 4 - will be the control group who receive follow-up and recommendation for physical activity, but without any intervention supervised. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Juvenile fibromyalgia diagnosis
- Age between ten to seventeen years and eleven months
Key exclusion criteria (3 listed)
- Previous treatment with acupuncture;
- Treatment with psychotherapy, exercise training, use of antidepressant and anti-inflammatory drugs in the last month;
- Inflammatory diseases, hypothyroidism and hyperthyroidism
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 |
|---|---|---|
| exercise trainingAlso: Multidisciplinary treatment including medication, Family education, Psychotherapy, Interventions to reduce painexercise training comprises aerobic and strength training | Procedure or surgery | exercise training resistance and aerobic |
| acupunctureAlso: Systematic study of physical activity and acupuncture have stimulatedacupuncture involves two sessions per week, during 14 weeks. | Procedure or surgery | acupuncture |
| Exercise, Acupuncture and FibromyalgiaAlso: Assess pain reduction, Improvement in quality of life in children and adolescents, Compare four treatment groupsSet of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, we just get guidance for physical activity. | Procedure or surgery | acupuncture, exercise training resistance and aerobic, healthy lifestyle, sham acupuncture |
Primary outcome
pain
Time frame: 14 weeks
Clinical evaluation of pain is made by a general questionnaire for pain and overall evaluation of the patient / family and professional by the Visual Analogue Scale. There will be pain as described in 18 points for fibromyalgia, using as instrument the pressure algiômetro Fischer, settling myalgic index.
2 secondary outcomes
quality of life
Time frame: 14 weeks
strength
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
Clóvis AA Silva, M.D, Ph.D principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training, acupuncture and Exercise, Acupuncture and Fibromyalgia in people with Fibromyalgia and Juvenile, run by University of Sao Paulo at 2 sites 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 2 inclusion and 3 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 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
pain (time frame: 14 weeks). 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 19 Jan 2012.