Trial Outcomes & Findings for Fibromyalgia Integrative Training for Teens (NCT NCT01981096)
NCT ID: NCT01981096
Last Updated: 2022-02-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline, post-treatment and 3-month follow-up
Results posted on
2022-02-11
Participant Flow
Participant milestones
| Measure |
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
|
Cognitive Behavioral Therapy
8 week (16 session) cognitive-behavioral therapy treatment.
Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
Post-treatment
|
17
|
19
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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
|
Cognitive Behavioral Therapy
8 week (16 session) cognitive-behavioral therapy treatment.
Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills
|
|---|---|---|
|
Overall Study
Parent illness
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Fibromyalgia Integrative Training for Teens
Baseline characteristics by cohort
| Measure |
Fibromyalgia Integrative Training
n=20 Participants
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
|
Cognitive Behavioral Therapy
n=20 Participants
8 week (16 session) cognitive-behavioral therapy treatment.
Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.15 years
STANDARD_DEVIATION 1.69 • n=5 Participants
|
15.50 years
STANDARD_DEVIATION 1.36 • n=7 Participants
|
15.33 years
STANDARD_DEVIATION 1.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-treatment and 3-month follow-upPopulation: 20 participants randomized in each group. 3 dropped out of study before post-treatment and follow-up assessments.
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.
Outcome measures
| Measure |
Fibromyalgia Integrative Training
n=20 Participants
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
|
Cognitive Behavioral Therapy
n=20 Participants
8 week (16 session) cognitive-behavioral therapy treatment.
Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills
|
|---|---|---|
|
Average Pain Intensity
Baseline
|
6.26 units on a scale
Standard Deviation 2.06
|
6.41 units on a scale
Standard Deviation 1.59
|
|
Average Pain Intensity
Post-treatment
|
4.69 units on a scale
Standard Deviation 2.13
|
6.38 units on a scale
Standard Deviation 2.31
|
|
Average Pain Intensity
Primary endpoint (3-month f/u)
|
4.62 units on a scale
Standard Deviation 1.90
|
6.55 units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, post-treatment and 3-month follow-upPopulation: 20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments.
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)
Outcome measures
| Measure |
Fibromyalgia Integrative Training
n=20 Participants
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
|
Cognitive Behavioral Therapy
n=20 Participants
8 week (16 session) cognitive-behavioral therapy treatment.
Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills
|
|---|---|---|
|
Functional Disability
Baseline
|
26.70 units on a scale
Standard Deviation 7.27
|
24.45 units on a scale
Standard Deviation 8.29
|
|
Functional Disability
Post-treatment
|
18.71 units on a scale
Standard Deviation 4.61
|
23.95 units on a scale
Standard Deviation 11.04
|
|
Functional Disability
Primary endpoint (3 month f/u)
|
19.76 units on a scale
Standard Deviation 5.55
|
22.68 units on a scale
Standard Deviation 9.01
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment, 3-month follow-upPopulation: 20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments.
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)
Outcome measures
| Measure |
Fibromyalgia Integrative Training
n=20 Participants
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
|
Cognitive Behavioral Therapy
n=20 Participants
8 week (16 session) cognitive-behavioral therapy treatment.
Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills
|
|---|---|---|
|
Depressive Symptoms
Baseline
|
15.8 score on a scale
Standard Deviation 6.85
|
14.05 score on a scale
Standard Deviation 6.18
|
|
Depressive Symptoms
Post-Treatment
|
11.71 score on a scale
Standard Deviation 5.7
|
13.79 score on a scale
Standard Deviation 7.56
|
|
Depressive Symptoms
3-month Follow-up
|
11.35 score on a scale
Standard Deviation 6.52
|
12.95 score on a scale
Standard Deviation 7.55
|
Adverse Events
Fibromyalgia Integrative Training
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fibromyalgia Integrative Training
n=20 participants at risk
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
|
Cognitive Behavioral Therapy
n=20 participants at risk
8 week (16 session) cognitive-behavioral therapy treatment.
Cognitive Behavioral Therapy: Therapy focused on training in behavioral pain coping skills
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
20.0%
4/20 • Number of events 5 • 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.
|
0.00%
0/20 • 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.
|
|
Injury, poisoning and procedural complications
Accidental injury
|
10.0%
2/20 • Number of events 2 • 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.
|
0.00%
0/20 • 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.
|
|
Psychiatric disorders
Pseudo-neurologic symptoms
|
10.0%
2/20 • Number of events 2 • 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.
|
0.00%
0/20 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.0%
1/20 • Number of events 1 • 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.
|
0.00%
0/20 • 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.
|
Additional Information
Susmita Kashikar-Zuck, PhD
Cincinnati Children's Hospital Medical Center
Phone: 513 636 6337
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place