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

June 9, 2010
January 18, 2012
June 2010
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01163409 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Exercise, Acupuncture and Fibromyalgia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Fibromyalgia
  • Juvenile
  • 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: 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: acupuncture
    will be made with classic acupuncture needling in traditional points, surpassing the skin
    Interventions:
    • Procedure: acupuncture
    • Procedure: Exercise, Acupuncture and Fibromyalgia
  • Experimental: sham acupuncture
    sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points.
    Intervention: Procedure: Exercise, Acupuncture and Fibromyalgia
  • Experimental: exercise training resistance and aerobic
    Aerobic exercise for 1 hour and resistance exercises for major muscle groups.
    Interventions:
    • Procedure: exercise training
    • Procedure: Exercise, Acupuncture and Fibromyalgia
  • 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.
    Intervention: Procedure: Exercise, Acupuncture and Fibromyalgia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
June 2014
June 2012   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01163409
exercisefibro
No
Clóvis Artur Almeida da Silva/ MD, PhD, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Clóvis AA Silva, M.D, Ph.D University of Sao Paulo
University of Sao Paulo
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP