Trial Outcomes & Findings for Coping Skills Training for Adolescents With Fibromyalgia (NCT NCT00086047)

Results Overview

Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

114 participants

Primary outcome timeframe

Baseline and 6 months (end of study)

Results posted on

2017-09-20

Participant Flow

Patients diagnosed with juvenile fibromyalgia (ages 11-18 years)were recruited from four pediatric rheumatology clinics in the Midwestern United States.

Patients were screened to determine eligibility for the study. if they met eligibility criteria, they were enrolled in the study and immediately randomized to one of the treatment arms.

Participant milestones

Participant milestones
Measure	Coping Skills Patients will receive 8 weeks of behavioral training in pain coping strategies	Education Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
Overall Study STARTED	57	57
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Coping Skills Patients will receive 8 weeks of behavioral training in pain coping strategies	Education Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
Overall Study Lost to Follow-up	7	6
Overall Study Physician Decision	0	1

Baseline Characteristics

Coping Skills Training for Adolescents With Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coping Skills n=57 Participants Patients will receive 8 weeks of behavioral training in pain coping strategies	Education n=57 Participants Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.	Total n=114 Participants Total of all reporting groups
Age, Categorical <=18 years	57 Participants n=5 Participants	57 Participants n=7 Participants	114 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15.2 years STANDARD_DEVIATION 1.8 • n=5 Participants	14.9 years STANDARD_DEVIATION 1.7 • n=7 Participants	15.0 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	51 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	57 participants n=7 Participants	114 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months (end of study)

Population: Intent to treat analysis

Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)

Outcome measures

Outcome measures
Measure	Coping Skills Training n=57 Participants Consists of training in pain management skills using cognitive-behavioral therapy techniques	Fibromyalgia Education n=55 Participants Consists of education about fibromyalgia and its management
Change in FDI (Functional Disability Inventory) Scores at End of Study Baseline FDI Score	21.4 units on a 0-60 scale 95% Confidence Interval 9.4 • Interval 18.9 to 23.9	19.2 units on a 0-60 scale 95% Confidence Interval 8.2 • Interval 17.0 to 21.3
Change in FDI (Functional Disability Inventory) Scores at End of Study End of Study FDI Score	13.4 units on a 0-60 scale 95% Confidence Interval 8.9 • Interval 10.9 to 15.9	17.0 units on a 0-60 scale 95% Confidence Interval 10.5 • Interval 14.0 to 19.9

SECONDARY outcome

Timeframe: 9 weeks and 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 weeks and 6 months

Outcome measures

Outcome data not reported

Adverse Events

Coping Skills

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susmita Kashikar-Zuck, PhD

Cincinnati Children's Hospital Medical Center

Phone: 513 636 6337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place