An interventional study of Fibromyalgia Integrative Training for Teens and Cognitive Behavioral Therapy in Fibromyalgia, Myofascial Pain Syndrome and Muscular Diseases, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 7 sites in 2 countries. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.
Behavioral: Fibromyalgia Integrative Training for Teens
Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements.
Behavioral: Cognitive Behavioral Therapy
Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.
Behavioral: Graded 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.
Also known as: FIT 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.
Also known as: CBT, coping skills
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.
Also known as: GAE
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
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
| Milestone | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise |
|---|---|---|---|
| Started | 103 | 110 | 104 |
| Completed primary endpoint | 87 | 93 | 79 |
| Completed | 83 | 89 | 72 |
| Not completed | 20 | 21 | 32 |
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).
| score on a scale | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise |
|---|---|---|---|
| Baseline | 25.78 (24.08 to 27.48) | 24.10 (22.31 to 25.89) | 25.96 (23.88 to 28.03) |
| 3-month endpoint | 21.83 (20.19 to 23.48) | 21.65 (19.86 to 23.43) | 24.70 (22.60 to 26.80) |
| 6-month endpoint | 21.26 (19.49 to 23.02) | 21.01 (19.09 to 22.93) | 23.34 (20.88 to 25.80) |
| 9-month endpoint | 21.56 (19.46 to 23.66) | 20.71 (18.54 to 22.88) | 23.37 (20.82 to 25.92) |
| 12-month endpoint | 21.02 (18.71 to 23.33) | 20.15 (18.08 to 22.21) | 21.22 (18.56 to 23.87) |
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.
| units on a scale | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise |
|---|---|---|---|
| Baseline | 5.71 (5.48 to 5.94) | 5.93 (5.66 to 6.21) | 5.88 (5.58 to 6.18) |
| 3-month endpoint | 5.29 (4.78 to 5.79) | 5.41 (4.95 to 5.87) | 5.44 (4.98 to 5.91) |
| 6-month endpoint | 5.27 (4.80 to 5.74) | 5.19 (4.76 to 5.62) | 5.42 (4.90 to 5.94) |
| 9-month endpoint | 5.07 (4.64 to 5.50) | 5.13 (4.73 to 5.54) | 5.45 (4.92 to 5.98) |
| 12-month endpoint | 4.91 (4.46 to 5.35) | 4.88 (4.48 to 5.28) | 5.18 (4.70 to 5.66) |
Collected over Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fibromyalgia Integrative Training for Teens | 0/103 (0%) | 0/103 (0%) | 12/103 (11.7%) |
| Cognitive Behavioral Therapy | 0/110 (0%) | 0/110 (0%) | 10/110 (9.1%) |
| Graded Aerobic Exercise | 0/104 (0%) | 0/104 (0%) | 16/104 (15.4%) |
| Event | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise |
|---|---|---|---|
| Extremity painMusculoskeletal and connective tissue disorders | 4/103 | 4/110 | 9/104 |
| Increased emotional distressPsychiatric disorders | 4/103 | 3/110 | 4/104 |
| Generalized weakness/painMusculoskeletal and connective tissue disorders | 1/103 | 1/110 | 2/104 |
| Sprain/strainMusculoskeletal and connective tissue disorders | 0/103 | 1/110 | 2/104 |
| FatigueEndocrine disorders | 1/103 | 0/110 | 0/104 |
| DizzinessNervous system disorders | 1/103 | 0/110 | 0/104 |
| Heat syncopeNervous system disorders | 1/103 | 0/110 | 0/104 |
| RashSkin and subcutaneous tissue disorders | 1/103 | 1/110 | 1/104 |
| Tachycardia/palpitationsCardiac disorders | 0/103 | 0/110 | 1/104 |
| Abdominal painGastrointestinal disorders | 0/103 | 0/110 | 1/104 |
While 389 participants were enrolled (signed consent and completed a pre-treatment assessment), 317 participants were randomized. This difference is due to screen-fails as well as those who voluntarily withdrew or were lost-to-contact prior to treatment assignment.
| Age, Categorical(Participants) | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise | Total |
|---|---|---|---|---|
| <=18 years | 103 | 110 | 104 | 317 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise | Total |
|---|---|---|---|---|
| Mean | 15.73 ± 1.49 | 15.61 ± 1.61 | 15.96 ± 1.47 | 15.76 ± 1.53 |
| Sex: Female, Male(Participants) | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise | Total |
|---|---|---|---|---|
| Female | 98 | 97 | 99 | 294 |
| Male | 5 | 13 | 5 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 11 | 9 | 25 |
| Not Hispanic or Latino | 98 | 99 | 95 | 292 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 3 | 0 | 4 |
| Asian | 1 | 0 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 7 | 7 | 4 | 18 |
| White | 85 | 92 | 90 | 267 |
| More than one race | 8 | 8 | 6 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise | Total |
|---|---|---|---|---|
| Canada | 0 | 3 | 0 | 3 |
| United States | 103 | 107 | 104 | 314 |
| Functional Disability Inventory (FDI)(units on a scale) | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise | Total |
|---|---|---|---|---|
| Mean | 25.73 ± 8.67 | 24.05 ± 7.95 | 25.95 ± 8.33 | 25.22 ± 5.84 |
| Pain Intensity (VAS)(units on a scale) | Fibromyalgia Integrative Training for Teens | Cognitive Behavioral Therapy | Graded Aerobic Exercise | Total |
|---|---|---|---|---|
| Mean | 5.71 ± 1.30 | 5.93 ± 1.34 | 5.88 ± 1.26 | 5.84 ± 1.30 |
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Children's Hospital Medical Center, Cincinnati