Fibromyalgia
Conditions
Keywords
Juvenile Fibromyalgia Syndrome, JPFS, Fibromyalgia, Chronic Pain, Pediatric Pain, Juvenile Fibromyalgia
Brief summary
Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and difficulty in an adolescent's day-to-day activities. The purpose of this study is to determine whether coping skills training, when combined with usual medical care, can reduce pain and disability in adolescents with fibromyalgia. Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual medical care will show significantly greater reductions in functional disability, pain, and depressive symptoms at the end of the acute treatment phase than adolescents who receive fibromyalgia education with their usual medical care. 2) Adolescents who receive coping skills training with their usual medical care will show significantly lower levels of functional disability, pain, and depressive symptoms at the end of a six-month maintenance phase than adolescents who receive fibromyalgia education with their usual medical care.
Detailed description
Juvenile Primary Fibromyalgia Syndrome (JPFS) is a debilitating chronic pain condition that occurs in adolescence and is characterized by persistent pain, multiple tender points, sleep difficulty, and fatigue. The cause of JPFS is unknown and there is no known cure. Children and adolescents with JPFS have difficulty with daily functioning, miss a great deal of school, and experience increased emotional distress compared to their peers. Fibromyalgia syndrome appears to be resistant to treatment in adulthood, so early behavioral treatment for JPFS with long-term beneficial effects would be useful. This study will evaluate the efficacy of coping skills training (CST) when combined with usual medical care in reducing functional disability, pain intensity, and depressive symptoms in adolescents with JPFS. This study will also determine whether improvements can be sustained long-term. This study will last 34 weeks. Participants will be recruited from three pediatric rheumatology clinics. Patients will be randomly assigned to one of two groups: CST plus usual medical care or education plus usual medical care. There will be 6 medical visits, spaced 4 to 5 weeks apart. In addition, patients will attend 8 individual sessions of CST or education over the first 8 weeks of the study. CST sessions will include training in cognitive-behavioral techniques of pain management for the adolescent and behavioral management techniques for their parents. Education sessions will include education on fibromyalgia and discussion about lifestyle issues, but no training in pain management procedures. Patients will be evaluated at Week 9 and will be followed for an additional 6-month maintenance phase. During this maintenance phase, adolescents will continue to receive their usual medical care and will attend 2 additional sessions of CST or education. There will be one final evaluation at the end of the maintenance phase.
Interventions
BEHAVIORALCoping Skills Training
8 weekly sessions of behavioral treatment
BEHAVIORALEducation
8 weekly sessions of fibromyalgia education
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of JPFS based upon widespread pain for over 3 months, at least 5 tender points, and associated features such as sleep difficulty, fatigue, and abdominal discomfort * Average pain intensity greater than 4 on the Visual Analog Scale * Functional disability score greater than 7 * Stable medications for 8 weeks prior to study entry
Exclusion criteria
* Other chronic rheumatic diseases, such as juvenile rheumatoid arthritis or lupus * Significant developmental delay or impairments, such as autism, cerebral palsy, or mental retardation * Present or lifetime psychiatric diagnosis that meets DSM-IV criteria for panic disorder, bipolar disorder, major depressive disorder, or psychosis * Opioid medications are disallowed when used on an ongoing basis for treatment of fibromyalgia pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FDI (Functional Disability Inventory) Scores at End of Study | Baseline and 6 months (end of study) | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Pain Intensity | 9 weeks and 6 months |
| Depressive Symptoms | 9 weeks and 6 months |
Countries
United States
Participant flow
Recruitment details
Patients diagnosed with juvenile fibromyalgia (ages 11-18 years)were recruited from four pediatric rheumatology clinics in the Midwestern United States.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Coping Skills Patients will receive 8 weeks of behavioral training in pain coping strategies | 57 |
| Education Patient will receive 8 weekly sessions of education about fibromyalgia syndrome. | 57 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Education | Coping Skills | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 57 Participants | 57 Participants | 114 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.9 years STANDARD_DEVIATION 1.7 | 15.2 years STANDARD_DEVIATION 1.8 | 15.0 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 57 participants | 57 participants | 114 participants |
| Sex: Female, Male Female | 51 Participants | 54 Participants | 105 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 55 |
| serious Total, serious adverse events | 0 / 57 | 0 / 55 |
Outcome results
Primary
Change in FDI (Functional Disability Inventory) Scores at End of Study
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)
Time frame: Baseline and 6 months (end of study)
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coping Skills Training | 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 |
| Coping Skills Training | 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 |
| Fibromyalgia Education | Change in FDI (Functional Disability Inventory) Scores at End of Study | Baseline FDI Score | 19.2 units on a 0-60 scale | 95% Confidence Interval 8.2 |
| Fibromyalgia Education | Change in FDI (Functional Disability Inventory) Scores at End of Study | End of Study FDI Score | 17.0 units on a 0-60 scale | 95% Confidence Interval 10.5 |
p-value: 0.00795% CI: [1.57, 9.22]Mixed Models Analysis
Secondary
Depressive Symptoms
Time frame: 9 weeks and 6 months
Secondary
Pain Intensity
Time frame: 9 weeks and 6 months