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| ID | Type | Description | Link |
|---|---|---|---|
| R21AR063412 | 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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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia Integrative Training | Experimental | 8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training |
|
| Cognitive Behavioral Therapy | Active Comparator | 8 week (16 session) cognitive-behavioral therapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibromyalgia integrative training | Behavioral | Combined intervention with neuromuscular exercise training and cognitive behavioral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-treatment and 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, post-treatment and 3-month follow-up |
| Depressive Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susmita Kashikar-Zuck, PhD | Cincinati Children's Hospital Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Cognitive Behavioral Therapy | 8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Cognitive Behavioral Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | 20 participants randomized in each group. 3 dropped out of study before post-treatment and follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, post-treatment and 3-month follow-up |
|
Five months (2 months in active treatment and 3 month follow-up phase)
The interventions in this study were purely behavioral and did not place any participants at risk for mortality or serious adverse events.
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susmita Kashikar-Zuck, PhD | Cincinnati Children's Hospital Medical Center | 513 636 6337 | susmita.kashikar-zuck@cchmc.org |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive Behavioral Therapy | Behavioral | Therapy focused on training in behavioral pain coping skills |
|
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) |
| Baseline, Post-treatment, 3-month follow-up |
| Lost to Follow-up |
|
8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills |
|
|
|
| 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) | 20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, post-treatment and 3-month follow-up |
|
|
|
|
| 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) | 20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-treatment, 3-month follow-up |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 7 |
| 20 |
| EG001 | Cognitive Behavioral Therapy | 8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills | 0 | 20 | 0 | 20 | 0 | 20 |
| Accidental injury | Injury, poisoning and procedural complications | Non-systematic Assessment | sports injury |
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| Pseudo-neurologic symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Post-treatment |
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| Primary endpoint (3 month f/u) |
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| Post-Treatment |
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| 3-month Follow-up |
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