FIT Teens: Fibromyalgia Integrative Training for Teens
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fibromyalgia Integrative Training 8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training |
Behavioral: Fibromyalgia integrative training
Combined intervention with neuromuscular exercise training and cognitive behavioral therapy
|
| Active Comparator: Cognitive Behavioral Therapy 8 week (16 session) cognitive-behavioral therapy treatment. |
Behavioral: Cognitive Behavioral Therapy
Therapy focused on training in behavioral pain coping skills
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
- Principal Investigator: Susmita Kashikar-Zuck, PhD, Cincinati Children's Hospital Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R21AR063412
- R21AR063412
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Fibromyalgia Integrative Training | Cognitive Behavioral Therapy |
|---|---|---|
| Arm/Group Description | 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 | 8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills |
| Period Title: Overall Study | ||
| STARTED | 20 | 20 |
| Post-treatment | 17 | 19 |
| COMPLETED | 17 | 19 |
| NOT COMPLETED | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Fibromyalgia Integrative Training | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills | Total of all reporting groups |
| Overall Participants | 20 | 20 | 40 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
15.15
(1.69)
|
15.50
(1.36)
|
15.33
(1.53)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
17
85%
|
19
95%
|
36
90%
|
| Male |
3
15%
|
1
5%
|
4
10%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
20
100%
|
20
100%
|
40
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
5%
|
1
5%
|
2
5%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
19
95%
|
18
90%
|
37
92.5%
|
| More than one race |
0
0%
|
1
5%
|
1
2.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
20
100%
|
20
100%
|
40
100%
|
Outcome Measures
| Title | Average Pain Intensity |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 participants randomized in each group. 3 dropped out of study before post-treatment and follow-up assessments. |
| Arm/Group Title | Fibromyalgia Integrative Training | Cognitive Behavioral Therapy |
|---|---|---|
| Arm/Group Description | 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 | 8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills |
| Measure Participants | 20 | 20 |
| Baseline |
6.26
(2.06)
|
6.41
(1.59)
|
| Post-treatment |
4.69
(2.13)
|
6.38
(2.31)
|
| Primary endpoint (3-month f/u) |
4.62
(1.90)
|
6.55
(1.22)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fibromyalgia Integrative Training, Cognitive Behavioral Therapy |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .011 |
| Comments | The a priori threshold was alpha = .05. | |
| Method | ANCOVA | |
| Comments | Adjusted for age and baseline pain levels | |
| Title | Functional Disability |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments. |
| Arm/Group Title | Fibromyalgia Integrative Training | Cognitive Behavioral Therapy |
|---|---|---|
| Arm/Group Description | 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 | 8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills |
| Measure Participants | 20 | 20 |
| Baseline |
26.70
(7.27)
|
24.45
(8.29)
|
| Post-treatment |
18.71
(4.61)
|
23.95
(11.04)
|
| Primary endpoint (3 month f/u) |
19.76
(5.55)
|
22.68
(9.01)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fibromyalgia Integrative Training, Cognitive Behavioral Therapy |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .055 |
| Comments | The a priori threshold was alpha = .05. | |
| Method | ANCOVA | |
| Comments | Adjusted for age and baseline pain levels | |
| Title | Depressive Symptoms |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments. |
| Arm/Group Title | Fibromyalgia Integrative Training | Cognitive Behavioral Therapy |
|---|---|---|
| Arm/Group Description | 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 | 8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills |
| Measure Participants | 20 | 20 |
| Baseline |
15.8
(6.85)
|
14.05
(6.18)
|
| Post-Treatment |
11.71
(5.7)
|
13.79
(7.56)
|
| 3-month Follow-up |
11.35
(6.52)
|
12.95
(7.55)
|
Adverse Events
| Time Frame | Five months (2 months in active treatment and 3 month follow-up phase) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The interventions in this study were purely behavioral and did not place any participants at risk for mortality or serious adverse events. | |||
| Arm/Group Title | Fibromyalgia Integrative Training | Cognitive Behavioral Therapy | ||
| Arm/Group Description | 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 | 8 week (16 session) cognitive-behavioral therapy treatment. Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills | ||
All Cause Mortality |
||||
| Fibromyalgia Integrative Training | Cognitive Behavioral Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Serious Adverse Events |
||||
| Fibromyalgia Integrative Training | Cognitive Behavioral Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Fibromyalgia Integrative Training | Cognitive Behavioral Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/20 (35%) | 0/20 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Accidental injury | 2/20 (10%) | 2 | 0/20 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Joint pain | 4/20 (20%) | 5 | 0/20 (0%) | 0 |
| Psychiatric disorders | ||||
| Pseudo-neurologic symptoms | 2/20 (10%) | 2 | 0/20 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Sinusitis | 1/20 (5%) | 1 | 0/20 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Susmita Kashikar-Zuck, PhD |
|---|---|
| Organization | Cincinnati Children's Hospital Medical Center |
| Phone | 513 636 6337 |
| susmita.kashikar-zuck@cchmc.org |
- R21AR063412
- R21AR063412