Fibromyalgia Integrative Training for Teens

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 (i.e., 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 (i.e., 3-month follow up).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

NCT03268421

Fibromyalgia Myofascial Pain Syndrome Muscular Diseases +2 more

COMPLETED NA

Coping Skills Training for Adolescents With Fibromyalgia

NCT00086047

Fibromyalgia

COMPLETED PHASE3

Behavioral Treatment of Fibromyalgia

NCT00000398

Fibromyalgia

COMPLETED PHASE2

Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population

NCT00909194

Juvenile Primary Fibromyalgia Syndrome

COMPLETED NA

Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia

NCT05058911

Fibromyalgia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Juvenile Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fibromyalgia Integrative Training

8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training

Group Type EXPERIMENTAL

Fibromyalgia integrative training

Intervention Type BEHAVIORAL

Combined intervention with neuromuscular exercise training and cognitive behavioral therapy

Cognitive Behavioral Therapy

8 week (16 session) cognitive-behavioral therapy treatment.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Therapy focused on training in behavioral pain coping skills

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fibromyalgia integrative training

Combined intervention with neuromuscular exercise training and cognitive behavioral therapy

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy

Therapy focused on training in behavioral pain coping skills

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males and females ages 12-18
* Juvenile fibromyalgia (JFM) diagnosed by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology (ACR) criteria and confirmation with a tender point exam of ≥ 11 of 18 tender points upon palpation
* 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

Exclusion Criteria

* Comorbid rheumatic disease (e.g., juvenile arthritis, systemic lupus erythematous)
* untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses)
* documented developmental delay
* any medical condition determined by their physician to be a contraindication for participation
* on stable medications for 4 weeks prior to enrollment
* currently in CBT or structured physical therapy program

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No