Exercise, Acupuncture and Fibromyalgia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01163409
First received: June 9, 2010
Last updated: January 18, 2012
Last verified: June 2010
  Purpose

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.


Condition Intervention
Fibromyalgia
Juvenile
Procedure: exercise training
Procedure: acupuncture
Procedure: Exercise, Acupuncture and Fibromyalgia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture and Physical Activity in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • pain [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 weeks ]
    will be assessed by means of 1-RM test


Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture
will be made with classic acupuncture needling in traditional points, surpassing the skin
Procedure: acupuncture
acupuncture involves two sessions per week, during 14 weeks.
Other Name: Systematic study of physical activity and acupuncture have stimulated
Procedure: Exercise, Acupuncture and 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, we just get guidance for physical activity.
Other Names:
  • Assess pain reduction
  • Improvement in quality of life in children and adolescents
  • Compare four treatment groups
Experimental: sham acupuncture
sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points.
Procedure: Exercise, Acupuncture and 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, we just get guidance for physical activity.
Other Names:
  • Assess pain reduction
  • Improvement in quality of life in children and adolescents
  • Compare four treatment groups
Experimental: exercise training resistance and aerobic
Aerobic exercise for 1 hour and resistance exercises for major muscle groups.
Procedure: exercise training
exercise training comprises aerobic and strength training
Other Names:
  • Multidisciplinary treatment including medication
  • Family education
  • Psychotherapy
  • Interventions to reduce pain
  • Improve sleep quality.
Procedure: Exercise, Acupuncture and 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, we just get guidance for physical activity.
Other Names:
  • Assess pain reduction
  • Improvement in quality of life in children and adolescents
  • Compare four treatment groups
No Intervention: healthy lifestyle
Group 4 - will be the control group who receive follow-up and recommendation for physical activity, but without any intervention supervised.
Procedure: Exercise, Acupuncture and 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, we just get guidance for physical activity.
Other Names:
  • Assess pain reduction
  • Improvement in quality of life in children and adolescents
  • Compare four treatment groups

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163409

Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 5511
Magda Maria Maia
São Paulo, Brazil, 5511
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Clóvis AA Silva, M.D, Ph.D University of Sao Paulo
  More Information

No publications provided

Responsible Party: Clóvis Artur Almeida da Silva/ MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01163409     History of Changes
Other Study ID Numbers: exercisefibro
Study First Received: June 9, 2010
Last Updated: January 18, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
juvenile fibromyalgia
acupuncture
exercise training

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014