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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR070474 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia Integrative Training for Teens | Experimental | 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. |
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| Cognitive Behavioral Therapy | Active Comparator | 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. |
|
| Graded Aerobic Exercise | Active Comparator | Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibromyalgia Integrative Training for Teens | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susmita Kashikar-Zuck, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States | ||
| Riley Children's Hospital-University of Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33618033 | Background | Kashikar-Zuck S, Briggs MS, Bout-Tabaku S, Connelly M, Daffin M, Guite J, Ittenbach R, Logan DE, Lynch-Jordan AM, Myer GD, Ounpuu S, Peugh J, Schikler K, Sugimoto D, Stinson JN, Ting TV, Thomas S, Williams SE, Zempsky W; Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol. Contemp Clin Trials. 2021 Apr;103:106321. doi: 10.1016/j.cct.2021.106321. Epub 2021 Feb 20. | |
| 36467389 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fibromyalgia Integrative Training for Teens | Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training. |
| FG001 | Cognitive Behavioral Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2022 | Nov 26, 2024 |
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Non-pharmacologic trial comparing behavioral and exercise-based treatments
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| Cognitive Behavioral Therapy | Behavioral | 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. |
|
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| Graded Aerobic Exercise | Behavioral | 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. |
|
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| Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Boston Chilldren's Hospital | Boston | Massachusetts | 02116 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Background |
| Kashikar-Zuck S, Barnett KA, Williams SE, Pfeiffer M, Thomas S, Beasley K, Chamberlin LA, Mundo K, Ittenbach RF, Peugh J, Gibler RC, Lynch-Jordan A, Ting TV, Gadd B, Taylor J, Goldstein-Leever A, Connelly M, Logan DE, Williams A, Wakefield EO, Myer GD; FIT Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic. Contemp Clin Trials Commun. 2022 Nov 29;30:101039. doi: 10.1016/j.conctc.2022.101039. eCollection 2022 Dec. |
| 38823603 | Derived | Kashikar-Zuck S, Thomas S, Bonnette S, Gibler RC, DiCesare C, Schille A, Hulburt T, Briggs MS, Ounpuu S, Myer GD; FIT Teens Clinical Trial Study Group. Comparison of Pain Characteristics, Strength, and Movement Patterns in Adolescents With Juvenile Fibromyalgia and High Versus Low Fear of Movement. J Pain. 2024 Sep;25(9):104586. doi: 10.1016/j.jpain.2024.104586. Epub 2024 May 31. |
| 36537193 | Derived | Lynch-Jordan AM, Connelly M, Guite JW, King C, Goldstein-Leever A, Logan DE, Nelson S, Stinson JN, Ting TV, Wakefield EO, Williams AE, Williams SE, Kashikar-Zuck S; Fibromyalgia Integrative Training for Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance Pain Workgroup Investigators. Clinical Characterization of Juvenile Fibromyalgia in a Multicenter Cohort of Adolescents Enrolled in a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1795-1803. doi: 10.1002/acr.25077. Epub 2023 Feb 16. |
Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program.
| FG002 | Graded Aerobic Exercise | Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks. |
| Completed Primary Endpoint |
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| COMPLETED | Completed Study |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fibromyalgia Integrative Training for Teens | Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training. |
| BG001 | Cognitive Behavioral Therapy | Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program. |
| BG002 | Graded Aerobic Exercise | Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Functional Disability Inventory (FDI) | Functional Disability Inventory (FDI) is a 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). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Pain Intensity (VAS) | 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. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up |
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| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up |
|
Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total.
General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibromyalgia Integrative Training for Teens | Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training. | 0 | 103 | 0 | 103 | 12 | 103 |
| EG001 | Cognitive Behavioral Therapy | Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program. | 0 | 110 | 0 | 110 | 10 | 110 |
| EG002 | Graded Aerobic Exercise | Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks. | 0 | 104 | 0 | 104 | 16 | 104 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Systematic Assessment |
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| Tachycardia/palpitations | Cardiac disorders | Systematic Assessment |
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| Fatigue | Endocrine disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Extremity pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Generalized weakness/pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sprain/strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Heat syncope | Nervous system disorders | Systematic Assessment |
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| Increased emotional distress | Psychiatric disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susmita Kashikar-Zuck, PhD | Cincinnati Children's Hospital | 513-636-6337 | susmita.kashikar-zuck@cchmc.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2024 | Nov 26, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009209 | Myofascial Pain Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000097813 | Coping Skills |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| 6-month endpoint |
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| 9-month endpoint |
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| 12-month endpoint |
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