Ignite Creation Date:
2024-05-06 @ 2:10 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01981096
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2013-10-24
Brief Title:
Fibromyalgia Integrative Training for Teens
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Fibromyalgia Integrative Training for Teens
Status:
COMPLETED
Status Verified Date:
2022-02
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:
The purpose of this pilot randomized trial is to determine whether the fibromyalgia integrative training FIT Teens intervention is superior to cognitive-behavioral therapy CBT alone in reducing pain among adolescents with juvenile fibromyalgia JFM
Hypothesis 1 Patients in the FIT Teens group will show significantly greater reduction in pain intensity than the CBT group at final study assessment ie 3-month follow up
Hypothesis 2 Patients in both the FIT Teens and CBT groups will show significant reductions in functional disability and depressive symptoms at final study assessment ie 3-month follow up
Hypothesis 1 Patients in the FIT Teens group will show significantly greater reduction in pain intensity than the CBT group at final study assessment ie 3-month follow up
Hypothesis 2 Patients in both the FIT Teens and CBT groups will show significant reductions in functional disability and depressive symptoms at final study assessment ie 3-month follow up
Detailed Description:
CBT has been found to have beneficial effects on improving coping among adolescents with JFM and increasing patients ability to engage in daily activities The purpose of this study is to evaluate whether CBT can be enhanced with specialized neuromuscular training in the new fibromyalgia integrative training FIT Teens intervention to produce stronger pain reduction than CBT alone Neuromuscular training originates from the field of pediatric sports medicine and has been successfully used for injury prevention but has never before been utilized for pain management in JFM This type of training emphasizes education and proper training in fundamental movement skills prior to the initiation of more vigorous physical activity and exercise It is expected that the neuromuscular training integrated with established CBT techniques will enhance patients ability to engage in exercise and to achieve better JFM pain control Adolescents with JFM will be randomly assigned to receive either the 8-week FIT Teens intervention or an 8-week CBT program with assessments at baseline post-treatment and 3-month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| R21AR063412 | NIH | None | httpsreporternihgovquickSearchR21AR063412 |