Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia

Conditions
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Fibromyalgia, Myofascial Pain Syndrome, Muscular Diseases, Musculoskeletal Disease, Rheumatic Diseases

Intervention / Treatment
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* Behavioral: Fibromyalgia Integrative Training for Teens
* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Graded Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use Functional Disability Score ≥ 13, indicating at least moderate disability Average pain intensity in the past week ≥ 4 on a 0 -10 cm Visual Analog Scale Stable medications prior to enrollment Exclusion Criteria: Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous) Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay Any medical condition determined by their physician to be a contraindication for physical exercise Taking opioid pain medication

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-pharmacologic trial comparing behavioral and exercise-based treatments
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibromyalgia Integrative Training for Teens<br>Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance. | Behavioral: Fibromyalgia Integrative Training for Teens<br>* 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.<br>* Other names: FIT Teens;|
| Active Comparator: Cognitive Behavioral Therapy<br>Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements. | Behavioral: Cognitive Behavioral Therapy<br>* 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.<br>* Other names: coping skills;|
| Active Comparator: Graded Aerobic Exercise<br>Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks. | Behavioral: Graded Aerobic Exercise<br>* 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.<br>* Other names: GAE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional disability | The Functional Disability Inventory (FDI), a 15 item self-report measure will be used to assess participant's perceived difficulty in the performance of daily activities at home, school, recreational, and social domains due to pain. For this primary outcome, data from this questionnaires will be used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs. The main outcome measure for this comparison will be the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE). | Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | A Visual Analog Scale (VAS) will be used to assess average pain intensity over a one week period | Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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musculoskeletal pain, juvenile fibromyalgia, pain in children, cognitive behavioral therapy, coping skills training, neuromuscular exercise, graded aerobic exercise