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Fibromyalgia Training for Fibromyalgia (FIT Teens Trial)

N/A

Waitlist Available

Led By Susmita Kashikar-Zuck, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up

Awards & highlights

FIT Teens Trial Summary

This trial will compare the effectiveness of two different treatments for Juvenile Fibromyalgia: CBT alone, and a combined CBT and exercise program.

Eligible Conditions

Fibromyalgia
Muscular Dystrophy
Musculoskeletal Disorders
Myofascial Pain Syndrome
Rheumatic Diseases

FIT Teens Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in functional disability

Secondary outcome measures

Change in pain intensity

FIT Teens Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Fibromyalgia Integrative Training for TeensExperimental Treatment1 Intervention

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.

Group II: Graded Aerobic ExerciseActive Control1 Intervention

Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.

Group III: Cognitive Behavioral TherapyActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fibromyalgia Integrative Training for Teens

2018

N/A

~390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

483 Previous Clinical Trials

1,086,551 Total Patients Enrolled

26 Trials studying Fibromyalgia

13,131 Patients Enrolled for Fibromyalgia

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,207 Total Patients Enrolled

5 Trials studying Fibromyalgia

794 Patients Enrolled for Fibromyalgia

Susmita Kashikar-Zuck, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

2 Previous Clinical Trials

154 Total Patients Enrolled

2 Trials studying Fibromyalgia

154 Patients Enrolled for Fibromyalgia

Media Library

Cognitive Behavioral Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03268421 — N/A

Fibromyalgia Research Study Groups: Graded Aerobic Exercise, Fibromyalgia Integrative Training for Teens, Cognitive Behavioral Therapy

Fibromyalgia Clinical Trial 2023: Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT03268421 — N/A

Cognitive Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03268421 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions for individuals interested in joining this research study?

"Based on the criteria for inclusion, the minimum and maximum age of participants is 12 and 18 respectively."

Answered by AI

Are participants still being accepted into this research project?

"Indeed, clinicaltrials.gov confirms that this clinical trial is currently accepting participants. The study was first advertised on January 2nd 2018 and most recently updated on August 2nd 2022; it requires 420 volunteers from 5 sites to reach its objectives."

Answered by AI

How many participants are being welcomed into this experiment?

"Indeed, the information posted on clinicaltrials.gov attests that this investigation is actively recruiting members. This medical trial was first advertised on January 2nd 2018 and most recently updated on August 2nd 2022; its aim being to recruit 420 individuals from 5 different sites."

Answered by AI

What are the criteria for eligibility to participate in this experiment?

"Patients aged 12-18 with rheumatic diseases can participate in this study. The prerequisites include an average pain intensity of 4 or higher on a 0 to 10 cm Visual Analog Scale and a Functional Disability Score greater than 13, which is indicative of moderate impairment. 420 participants are required overall."

Answered by AI

Is this experimentation being conducted at multiple sites across North America?

"This trial is currently running at 5 locations, including Indianapolis, Cincinnati and Hartford. To reduce travel expenses associated with the experiment, it's important to select a clinic that is closest to you. Additionally there are another two unspecified sites hosting this research."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

Randomized Clinical Trial of Fibromyalgia Integrative Training (FIT Teens) for Adolescents with Juvenile Fibromyalgia – Study Design and Protocol

Kashikar-Zuck, Susmita, Matthew S. Briggs, Sharon Bout-Tabaku, Mark Connelly, Morgan Daffin, Jessica Guite, Richard Ittenbach, et al.. 2021. “Randomized Clinical Trial of Fibromyalgia Integrative Training (FIT Teens) for Adolescents with Juvenile Fibromyalgia – Study Design and Protocol”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106321.

clinicaltrials.govStudy

Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

2018. "Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03268421.