Exercise, Acupuncture and Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Acupuncture and Physical Activity in Patients With Fibromyalgia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01163409
• Other study ID #: exercisefibro
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 9, 2010
• Last updated: January 18, 2012
• Start date: June 2010
• Est. completion date: June 2014

Study information

• Verified date: June 2010
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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 supervised versus group control, who just get guidance for physical activity.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Juvenile
• Myofascial Pain Syndromes

Intervention

Procedure:
• exercise training
exercise training comprises aerobic and strength training
• acupuncture
acupuncture involves two sessions per week, during 14 weeks.
• 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo
Brazil	Magda Maria Maia	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 weeks	Yes
Secondary	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.	14 weeks	No
Secondary	strength	will be assessed by means of 1-RM test	14 weeks