Juvenile Fibromyalgia
Conditions
Keywords
juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training
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).
Detailed description
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.
Interventions
BEHAVIORALFibromyalgia integrative training
Combined intervention with neuromuscular exercise training and cognitive behavioral therapy
BEHAVIORALCognitive Behavioral Therapy
Therapy focused on training in behavioral pain coping skills
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 (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Intensity | Baseline, post-treatment and 3-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability | Baseline, post-treatment and 3-month follow-up | Validated 15-item patient-report measure of difficulties in physical, social and recreational activities in the past 2 weeks (score Min = 0, Max = 60; Lower score means less disability/better outcome) |
| Depressive Symptoms | Baseline, Post-treatment, 3-month follow-up | Children's Depression Inventory: a 27-item validated patient-report measure of depressive symptoms in the past 2 weeks (scores 0 = no depressive symptoms to 54 = most severe symptoms; lower score means less depression/better outcomes) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fibromyalgia Integrative Training 8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training
Fibromyalgia integrative training: Combined intervention with neuromuscular exercise training and cognitive behavioral therapy | 20 |
| Cognitive Behavioral Therapy 8 week (16 session) cognitive-behavioral therapy treatment.
Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Parent illness | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Fibromyalgia Integrative Training | Total | Cognitive Behavioral Therapy |
|---|---|---|---|
| Age, Continuous | 15.15 years STANDARD_DEVIATION 1.69 | 15.33 years STANDARD_DEVIATION 1.53 | 15.50 years STANDARD_DEVIATION 1.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 40 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 37 Participants | 18 Participants |
| Region of Enrollment United States | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Female | 17 Participants | 36 Participants | 19 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 7 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Baseline, post-treatment and 3-month follow-up
Population: 20 participants randomized in each group. 3 dropped out of study before post-treatment and follow-up assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fibromyalgia Integrative Training | Average Pain Intensity | Baseline | 6.26 units on a scale | Standard Deviation 2.06 |
| Fibromyalgia Integrative Training | Average Pain Intensity | Post-treatment | 4.69 units on a scale | Standard Deviation 2.13 |
| Fibromyalgia Integrative Training | Average Pain Intensity | Primary endpoint (3-month f/u) | 4.62 units on a scale | Standard Deviation 1.9 |
| Cognitive Behavioral Therapy | Average Pain Intensity | Baseline | 6.41 units on a scale | Standard Deviation 1.59 |
| Cognitive Behavioral Therapy | Average Pain Intensity | Post-treatment | 6.38 units on a scale | Standard Deviation 2.31 |
| Cognitive Behavioral Therapy | Average Pain Intensity | Primary endpoint (3-month f/u) | 6.55 units on a scale | Standard Deviation 1.22 |
Comparison: This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.p-value: 0.011ANCOVA
Secondary
Depressive Symptoms
Children's Depression Inventory: a 27-item validated patient-report measure of depressive symptoms in the past 2 weeks (scores 0 = no depressive symptoms to 54 = most severe symptoms; lower score means less depression/better outcomes)
Time frame: Baseline, Post-treatment, 3-month follow-up
Population: 20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fibromyalgia Integrative Training | Depressive Symptoms | Baseline | 15.8 score on a scale | Standard Deviation 6.85 |
| Fibromyalgia Integrative Training | Depressive Symptoms | Post-Treatment | 11.71 score on a scale | Standard Deviation 5.7 |
| Fibromyalgia Integrative Training | Depressive Symptoms | 3-month Follow-up | 11.35 score on a scale | Standard Deviation 6.52 |
| Cognitive Behavioral Therapy | Depressive Symptoms | Baseline | 14.05 score on a scale | Standard Deviation 6.18 |
| Cognitive Behavioral Therapy | Depressive Symptoms | Post-Treatment | 13.79 score on a scale | Standard Deviation 7.56 |
| Cognitive Behavioral Therapy | Depressive Symptoms | 3-month Follow-up | 12.95 score on a scale | Standard Deviation 7.55 |
Secondary
Functional Disability
Validated 15-item patient-report measure of difficulties in physical, social and recreational activities in the past 2 weeks (score Min = 0, Max = 60; Lower score means less disability/better outcome)
Time frame: Baseline, post-treatment and 3-month follow-up
Population: 20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fibromyalgia Integrative Training | Functional Disability | Baseline | 26.70 units on a scale | Standard Deviation 7.27 |
| Fibromyalgia Integrative Training | Functional Disability | Post-treatment | 18.71 units on a scale | Standard Deviation 4.61 |
| Fibromyalgia Integrative Training | Functional Disability | Primary endpoint (3 month f/u) | 19.76 units on a scale | Standard Deviation 5.55 |
| Cognitive Behavioral Therapy | Functional Disability | Baseline | 24.45 units on a scale | Standard Deviation 8.29 |
| Cognitive Behavioral Therapy | Functional Disability | Post-treatment | 23.95 units on a scale | Standard Deviation 11.04 |
| Cognitive Behavioral Therapy | Functional Disability | Primary endpoint (3 month f/u) | 22.68 units on a scale | Standard Deviation 9.01 |
Comparison: This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.p-value: 0.055ANCOVA