Exercise, Acupuncture and Fibromyalgia
Primary Purpose
Fibromyalgia, Juvenile
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
exercise training
acupuncture
Exercise, Acupuncture and Fibromyalgia
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring juvenile fibromyalgia, acupuncture, exercise training
Eligibility Criteria
Inclusion Criteria:
- Juvenile fibromyalgia diagnosis
- Age between ten to seventeen years and eleven months
Exclusion Criteria:
- 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
Sites / Locations
- University of Sao Paulo
- Magda Maria Maia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
acupuncture
sham acupuncture
exercise training resistance and aerobic
healthy lifestyle
Arm Description
will be made with classic acupuncture needling in traditional points, surpassing the skin
sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points.
Aerobic exercise for 1 hour and resistance exercises for major muscle groups.
Group 4 - will be the control group who receive follow-up and recommendation for physical activity, but without any intervention supervised.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
strength
will be assessed by means of 1-RM test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01163409
Brief Title
Exercise, Acupuncture and Fibromyalgia
Official Title
Acupuncture and Physical Activity in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Juvenile
Keywords
juvenile fibromyalgia, acupuncture, exercise training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture
Arm Type
Experimental
Arm Description
will be made with classic acupuncture needling in traditional points, surpassing the skin
Arm Title
sham acupuncture
Arm Type
Experimental
Arm Description
sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points.
Arm Title
exercise training resistance and aerobic
Arm Type
Experimental
Arm Description
Aerobic exercise for 1 hour and resistance exercises for major muscle groups.
Arm Title
healthy lifestyle
Arm Type
No Intervention
Arm Description
Group 4 - will be the control group who receive follow-up and recommendation for physical activity, but without any intervention supervised.
Intervention Type
Procedure
Intervention Name(s)
exercise training
Other Intervention Name(s)
Multidisciplinary treatment including medication, Family education, Psychotherapy, Interventions to reduce pain, Improve sleep quality.
Intervention Description
exercise training comprises aerobic and strength training
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
Systematic study of physical activity and acupuncture have stimulated
Intervention Description
acupuncture involves two sessions per week, during 14 weeks.
Intervention Type
Procedure
Intervention Name(s)
Exercise, Acupuncture and Fibromyalgia
Other Intervention Name(s)
Assess pain reduction, Improvement in quality of life in children and adolescents, Compare four treatment groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
quality of life
Description
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.
Time Frame
14 weeks
Title
strength
Description
will be assessed by means of 1-RM test
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Juvenile fibromyalgia diagnosis
Age between ten to seventeen years and eleven months
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clóvis AA Silva, M.D, Ph.D
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
5511
Country
Brazil
Facility Name
Magda Maria Maia
City
São Paulo
ZIP/Postal Code
5511
Country
Brazil
12. IPD Sharing Statement
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Exercise, Acupuncture and Fibromyalgia
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