Juvenile FibromyalgiaFIT TeensNCT01981096
Fibromyalgia Integrative Training for Teens
A study testing Fibromyalgia integrative training and Cognitive Behavioral Therapy in people with Juvenile Fibromyalgia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Juvenile Fibromyalgia
- What is being tested?
- Fibromyalgia integrative training and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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).
Read the 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.
- Conditions
- Juvenile Fibromyalgia
- Being tested
- Fibromyalgia integrative training, Cognitive Behavioral Therapy
- Keywords
- juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibromyalgia integrative trainingBehavioural
Combined intervention with neuromuscular exercise training and cognitive behavioral therapy
Cognitive Behavioral TherapyBehavioural
Therapy focused on training in behavioral pain coping skills
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia Integrative Training | Experimental | 8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training Receives: Behavioral: Fibromyalgia integrative training |
| Cognitive Behavioral Therapy | Active comparator | 8 week (16 session) cognitive-behavioral therapy treatment. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-treatment and 3-month follow-up
Secondary outcomes (2)
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)
Measured: Baseline, post-treatment and 3-month follow-up
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)
Measured: Baseline, Post-treatment, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Juvenile FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Susmita Kashikar-Zuck, PhD, Principal investigator, Cincinati Children's Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981096
- Sponsor's protocol ID
- R21AR063412
- Other IDs
- R21AR063412
- Acronym
- FIT Teens
- Status last verified
- Feb 2022
- First submitted
- 24 Oct 2013
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia Integrative Training for Teens
- ClinicalTrials.gov ID
- NCT01981096
- Acronym / sponsor ID
- FIT Teens / R21AR063412
- Conditions
- Juvenile Fibromyalgia
- Keywords
- juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 10 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Integrative Training | Experimental | Behavioral: Fibromyalgia integrative training8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral Therapy8 week (16 session) cognitive-behavioral therapy treatment. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibromyalgia integrative trainingCombined intervention with neuromuscular exercise training and cognitive behavioral therapy | Behavioural | Fibromyalgia Integrative Training |
| Cognitive Behavioral TherapyTherapy focused on training in behavioral pain coping skills | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Average Pain Intensity
Time frame: 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.
2 secondary outcomes
Functional Disability
Time frame: Baseline, post-treatment and 3-month follow-up
Depressive Symptoms
Time frame: Baseline, Post-treatment, 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susmita Kashikar-Zuck, PhD principal investigator
Cincinati Children's Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibromyalgia integrative training and Cognitive Behavioral Therapy in people with Juvenile Fibromyalgia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Intensity (time frame: Baseline, post-treatment and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.