Fibromyalgia, Muscular Diseases, Musculoskeletal Disease, Myofascial Pain Syndrome, Rheumatic Diseases
Conditions
Keywords
juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training, neuromuscular exercise, graded aerobic exercise
Brief summary
This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.
Detailed description
Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically persists into adulthood for the majority of patients. Whereas medications offer limited and short-term symptom relief for JFM, our research group has demonstrated that cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional disability and depressive symptoms in adolescents with this condition. However, 60% of patients receiving CBT did not show clinically significant improvement in functional disability, and pain levels remained in the moderate range despite being reduced overall. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science has developed and tested the feasibility of a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances the established CBT intervention with a novel neuromuscular exercise training program derived from evidence-based pediatric injury prevention research. Pilot testing showed excellent patient engagement, no adverse effects and very promising early results indicating this treatment to have even stronger effects on disability and pain outcomes than CBT alone. This trial evaluated whether the FIT Teens intervention is more effective than CBT alone or graded aerobic exercise alone and whether treatment effects are sustainable over 1 year follow-up.
Interventions
BEHAVIORALFibromyalgia Integrative Training for Teens
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
BEHAVIORALCognitive Behavioral Therapy
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
BEHAVIORALGraded Aerobic Exercise
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
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
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Non-pharmacologic trial comparing behavioral and exercise-based treatments
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use * 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 * Stable medications prior to enrollment
Exclusion criteria
* Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous) * Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay * Any medical condition determined by their physician to be a contraindication for physical exercise * Taking opioid pain medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability Inventory | Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up | Functional Disability Inventory (FDI) is a validated 15-item self-report measure, developed to assess perceived difficulty in the performance of daily activities in home, school, recreational, and social domains due to pain. Total sum scores are calculated and range from 0 - 60, with higher scores indicating greater functional disability. Clinical reference points are: No/Minimal disability (0 to 12), Mild disability (13 to 20), Moderate disability (21 to 29) and Severe disability (≥30). For this primary outcome, data from this questionnaire was used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs. The main outcome measure for this comparison is the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intenstiy | Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up | Pain intensity was measured using the Visual Analog Scale (VAS), which is a validated measure of pain intensity in children and adolescents. Participants were shown a line with the written anchors of no pain and pain as bad as I can imagine on either end. The line represents a 0-10 scale, where higher scores are representative of higher pain intensity with a score of 4-6 indicating at least moderate pain levels and a score of 7-10 indicating severe pain levels. This measure was completed daily for one week and scores averaged over that time. For this secondary outcome, data from this measure were used to compare baseline response to 3 month follow up to examine whether a reduction in pain intensity occurred. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Due to the group-based nature of the study, potential participants completed their baseline (T1) assessment and then waited up to 4 weeks before treatment assignment. A potential participant would be excluded from the study prior to treatment assignment for the reasons of screen-fails, no longer interested in the study, starting a disallowed treatment, or are lost to contact.
Participants by arm
| Arm | Count |
|---|---|
| Fibromyalgia Integrative Training for Teens Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training. | 103 |
| Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program. | 110 |
| Graded Aerobic Exercise Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks. | 104 |
| Total | 317 |
Baseline characteristics
| Characteristic | Fibromyalgia Integrative Training for Teens | Total | Graded Aerobic Exercise | Cognitive Behavioral Therapy |
|---|---|---|---|---|
| Age, Categorical <=18 years | 103 Participants | 317 Participants | 104 Participants | 110 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.73 years STANDARD_DEVIATION 1.49 | 15.76 years STANDARD_DEVIATION 1.53 | 15.96 years STANDARD_DEVIATION 1.47 | 15.61 years STANDARD_DEVIATION 1.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 25 Participants | 9 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 292 Participants | 95 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Functional Disability Inventory (FDI) | 25.73 units on a scale STANDARD_DEVIATION 8.67 | 25.22 units on a scale STANDARD_DEVIATION 5.84 | 25.95 units on a scale STANDARD_DEVIATION 8.33 | 24.05 units on a scale STANDARD_DEVIATION 7.95 |
| Pain Intensity (VAS) | 5.71 units on a scale STANDARD_DEVIATION 1.3 | 5.84 units on a scale STANDARD_DEVIATION 1.3 | 5.88 units on a scale STANDARD_DEVIATION 1.26 | 5.93 units on a scale STANDARD_DEVIATION 1.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 18 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 22 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 85 Participants | 267 Participants | 90 Participants | 92 Participants |
| Region of Enrollment Canada | 0 participants | 3 participants | 0 participants | 3 participants |
| Region of Enrollment United States | 103 participants | 314 participants | 104 participants | 107 participants |
| Sex: Female, Male Female | 98 Participants | 294 Participants | 99 Participants | 97 Participants |
| Sex: Female, Male Male | 5 Participants | 23 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 110 | 0 / 104 |
| other Total, other adverse events | 12 / 103 | 10 / 110 | 16 / 104 |
| serious Total, serious adverse events | 0 / 103 | 0 / 110 | 0 / 104 |
Outcome results
Primary
Functional Disability Inventory
Functional Disability Inventory (FDI) is a validated 15-item self-report measure, developed to assess perceived difficulty in the performance of daily activities in home, school, recreational, and social domains due to pain. Total sum scores are calculated and range from 0 - 60, with higher scores indicating greater functional disability. Clinical reference points are: No/Minimal disability (0 to 12), Mild disability (13 to 20), Moderate disability (21 to 29) and Severe disability (≥30). For this primary outcome, data from this questionnaire was used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs. The main outcome measure for this comparison is the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).
Time frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fibromyalgia Integrative Training for Teens | Functional Disability Inventory | 9-month endpoint | 21.56 score on a scale |
| Fibromyalgia Integrative Training for Teens | Functional Disability Inventory | 6-month endpoint | 21.26 score on a scale |
| Fibromyalgia Integrative Training for Teens | Functional Disability Inventory | Baseline | 25.78 score on a scale |
| Fibromyalgia Integrative Training for Teens | Functional Disability Inventory | 3-month endpoint | 21.83 score on a scale |
| Fibromyalgia Integrative Training for Teens | Functional Disability Inventory | 12-month endpoint | 21.02 score on a scale |
| Cognitive Behavioral Therapy | Functional Disability Inventory | 6-month endpoint | 21.01 score on a scale |
| Cognitive Behavioral Therapy | Functional Disability Inventory | Baseline | 24.10 score on a scale |
| Cognitive Behavioral Therapy | Functional Disability Inventory | 3-month endpoint | 21.65 score on a scale |
| Cognitive Behavioral Therapy | Functional Disability Inventory | 9-month endpoint | 20.71 score on a scale |
| Cognitive Behavioral Therapy | Functional Disability Inventory | 12-month endpoint | 20.15 score on a scale |
| Graded Aerobic Exercise | Functional Disability Inventory | 12-month endpoint | 21.22 score on a scale |
| Graded Aerobic Exercise | Functional Disability Inventory | 9-month endpoint | 23.37 score on a scale |
| Graded Aerobic Exercise | Functional Disability Inventory | Baseline | 25.96 score on a scale |
| Graded Aerobic Exercise | Functional Disability Inventory | 6-month endpoint | 23.34 score on a scale |
| Graded Aerobic Exercise | Functional Disability Inventory | 3-month endpoint | 24.70 score on a scale |
Secondary
Pain Intenstiy
Pain intensity was measured using the Visual Analog Scale (VAS), which is a validated measure of pain intensity in children and adolescents. Participants were shown a line with the written anchors of no pain and pain as bad as I can imagine on either end. The line represents a 0-10 scale, where higher scores are representative of higher pain intensity with a score of 4-6 indicating at least moderate pain levels and a score of 7-10 indicating severe pain levels. This measure was completed daily for one week and scores averaged over that time. For this secondary outcome, data from this measure were used to compare baseline response to 3 month follow up to examine whether a reduction in pain intensity occurred.
Time frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fibromyalgia Integrative Training for Teens | Pain Intenstiy | 9-month endpoint | 5.07 units on a scale |
| Fibromyalgia Integrative Training for Teens | Pain Intenstiy | 6-month endpoint | 5.27 units on a scale |
| Fibromyalgia Integrative Training for Teens | Pain Intenstiy | 12-month endpoint | 4.91 units on a scale |
| Fibromyalgia Integrative Training for Teens | Pain Intenstiy | 3-month endpoint | 5.29 units on a scale |
| Fibromyalgia Integrative Training for Teens | Pain Intenstiy | Baseline | 5.71 units on a scale |
| Cognitive Behavioral Therapy | Pain Intenstiy | Baseline | 5.93 units on a scale |
| Cognitive Behavioral Therapy | Pain Intenstiy | 3-month endpoint | 5.41 units on a scale |
| Cognitive Behavioral Therapy | Pain Intenstiy | 6-month endpoint | 5.19 units on a scale |
| Cognitive Behavioral Therapy | Pain Intenstiy | 9-month endpoint | 5.13 units on a scale |
| Cognitive Behavioral Therapy | Pain Intenstiy | 12-month endpoint | 4.88 units on a scale |
| Graded Aerobic Exercise | Pain Intenstiy | 12-month endpoint | 5.18 units on a scale |
| Graded Aerobic Exercise | Pain Intenstiy | 9-month endpoint | 5.45 units on a scale |
| Graded Aerobic Exercise | Pain Intenstiy | Baseline | 5.88 units on a scale |
| Graded Aerobic Exercise | Pain Intenstiy | 6-month endpoint | 5.42 units on a scale |
| Graded Aerobic Exercise | Pain Intenstiy | 3-month endpoint | 5.44 units on a scale |