Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03268421
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2017-08-29
Brief Title:
Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIT Teens
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR070474 | NIH | None | httpsreporternihgovquickSearchR01AR070474 |