Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
Condition: Fibromyalgia; Myofascial Pain Syndrome; Muscular Diseases; Musculoskeletal Disease; Rheumatic Diseases
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Rheumatic Diseases; Musculoskeletal Diseases; Muscular Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      This study evaluates whether Fibromyalgia Integrative Training program for Teens (FIT Teens),
      a combined cognitive behavioral therapy and neuromuscular exercise training program is more
      effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to
      cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone.
      One third of participants will receive the FIT Teens training; one third will receive CBT
      training; and one third of participants will receive the GAE training.
    

Detailed description: 
      Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically
      persists into adulthood for the majority of patients. Whereas medications offer limited and
      short-term symptom relief for JFM, our research group has demonstrated that
      cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional
      disability and depressive symptoms in adolescents with this condition. However, 60% of
      patients receiving CBT did not show clinically significant improvement in functional
      disability, and pain levels remained in the moderate range despite being reduced overall. Our
      multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science
      has developed and tested the feasibility of a new Fibromyalgia Integrative Training program
      for Teens (FIT Teens), which enhances the established CBT intervention with a novel
      neuromuscular exercise training program derived from evidence-based pediatric injury
      prevention research. Pilot testing showed excellent patient engagement, no adverse effects
      and very promising early results indicating this treatment to have even stronger effects on
      disability and pain outcomes than CBT alone. This trial evaluates whether the FIT Teens
      intervention is more effective than CBT alone or graded aerobic exercise alone and whether
      treatment effects are sustainable over 1 year follow-up.
    

Intervention name(s): Fibromyalgia Integrative Training for Teens; Cognitive Behavioral Therapy; Graded Aerobic Exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.; This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.; This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
Other intervention name(s): FIT Teens; CBT; coping skills; GAE
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-pharmacologic trial comparing behavioral and exercise-based treatments
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: juvenile fibromyalgia; pain in children; musculoskeletal pain; cognitive behavioral therapy; coping skills training; neuromuscular exercise; graded aerobic exercise