Clinical trial NCT03268421: Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
Official title: Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Myofascial Pain Syndrome
Muscular Diseases
Musculoskeletal Disease
Rheumatic Diseases
Keywords: juvenile fibromyalgia
pain in children
musculoskeletal pain
cognitive behavioral therapy
coping skills training
neuromuscular exercise
graded aerobic exercise
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2017-08-31
Enrollment: 389
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-pharmacologic trial comparing behavioral and exercise-based treatments
Primary purpose: TREATMENT

Brief summary: This study evaluated 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 received the FIT Teens training; one third received CBT training; and one third of participants received 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 evaluated 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Disability Inventory
timeFrame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
Secondary outcomes:
measure: Pain Intenstiy
timeFrame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Indianapolis
country: United States
facility: Riley Children's Hospital-University of Indiana
state: Indiana
city: Boston
country: United States
facility: Boston Chilldren's Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Susmita Kashikar-Zuck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kashikar-Zuck S, Briggs MS, Bout-Tabaku S, Connelly M, Daffin M, Guite J, Ittenbach R, Logan DE, Lynch-Jordan AM, Myer GD, Ounpuu S, Peugh J, Schikler K, Sugimoto D, Stinson JN, Ting TV, Thomas S, Williams SE, Zempsky W; Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol. Contemp Clin Trials. 2021 Apr;103:106321. doi: 10.1016/j.cct.2021.106321. Epub 2021 Feb 20.
citation: Kashikar-Zuck S, Barnett KA, Williams SE, Pfeiffer M, Thomas S, Beasley K, Chamberlin LA, Mundo K, Ittenbach RF, Peugh J, Gibler RC, Lynch-Jordan A, Ting TV, Gadd B, Taylor J, Goldstein-Leever A, Connelly M, Logan DE, Williams A, Wakefield EO, Myer GD; FIT Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic. Contemp Clin Trials Commun. 2022 Nov 29;30:101039. doi: 10.1016/j.conctc.2022.101039. eCollection 2022 Dec.