NCT01981096

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 (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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 10, 2018

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

2.7 years

First QC Date

October 24, 2013

Results QC Date

April 11, 2018

Last Update Submit

February 9, 2022

Conditions

Juvenile Fibromyalgia

Keywords

juvenile fibromyalgiapain in childrenmusculoskeletal paincognitive behavioral therapycoping skills training

Outcome Measures

Primary Outcomes (1)

  • Average Pain Intensity

    Average pain intensity in the past week marked on a paper-pencil Visual Analog Scale (Min = 0 {no pain} to Max = 10 {pain as bad as it can be}). Lower scores mean better outcomes.

    Baseline, post-treatment and 3-month follow-up

Secondary Outcomes (2)

  • Functional Disability

    Baseline, post-treatment and 3-month follow-up

  • Depressive Symptoms

    Baseline, Post-treatment, 3-month follow-up

Study Arms (2)

Fibromyalgia Integrative Training

EXPERIMENTAL

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

Behavioral: Fibromyalgia integrative training

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy

Interventions

Fibromyalgia integrative trainingBEHAVIORAL

Combined intervention with neuromuscular exercise training and cognitive behavioral therapy

Fibromyalgia Integrative Training
Cognitive Behavioral TherapyBEHAVIORAL

Therapy focused on training in behavioral pain coping skills

Cognitive Behavioral Therapy

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Susmita Kashikar-Zuck, PhD
Organization
Cincinnati Children's Hospital Medical Center
susmita.kashikar-zuck@cchmc.org
513 636 6337

Study Officials

  • Susmita Kashikar-Zuck, PhD

    Cincinati Children's Hospital Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 11, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

February 11, 2022

Results First Posted

September 10, 2018

Record last verified: 2022-02

Locations

US(1)