View Clinical Trial (Medical Research Study)
Migraine and Recurrent Abdominal Pain in Children - NCT00060619-02115(Clinical Trial 116390)
ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.
| City: |
|
Boston |
|
State:
|
|
MA |
| Zip Code: |
|
02115 |
| Conditions: |
|
Migraine - Abdominal Pain |
| Purpose: |
|
This study will evaluate a new model for assessing and treating migraine and recurrent
abdominal pain in children. The model combines behavioral techniques such as relaxation
training with biologic components such as thermal biofeedback.
|
| Study summary: |
|
Recurrent pain syndromes (RPS) are relatively common in pediatric populations. Two of the
most common types of RPS are recurrent abdominal pain (RAP) and migraine. Similar patterns
of pain are described in children with RAP and migraine, and similar factors (particularly
stress) may initiate both types of RPS.
This study will assess a new biobehavioral model for evaluating and treating children with
RPS. This model relates precipitating, intervening, and functional status factors in
chronic and recurring pain in children. The model proposes that stress is a precipitant of
pain. This study will evaluate the model in children who receive therapy for RPS that is
based on stress management strategies. The therapy includes relaxation training, cognitive
coping skills training, thermal biofeedback, and parent education. It will be compared to a
control treatment program of hand-cooling biofeedback and supportive therapy.
Consenting participants will be randomized to receive either biobehavioral therapy or
control therapy. Participants will have 6 study visits over the course of 2 months. The
first study visit is an evaluation visit; the remaining five study visits are treatment
visits. Participants will be followed for 24 months and will be asked to complete mail-in
forms at Months 3, 6, 12, and 24.
Participants will be recruited through local pediatricians, pediatric neurologists, and
pediatric gastroenterologists. Brochures about the study will be sent to these physicians
to pass on to their patients informing them about the study. Children in the control group
will be recruited through Children's Hospital outpatient clinics. |
| Criteria: |
|
Inclusion Criteria
- Migraine or functional abdominal pain of at least 3 months duration, occurring at
least weekly or 5 days per month
- Child assent
- Parental consent
Exclusion Criteria
- Medical illnesses that cause similar pain symptoms (e.g., inflammatory bowel disease,
brain cancer)
- Psychiatric diagnosis that would interfere with participation in the study (any Axis
I diagnosis of moderate severity) |
|
|
|
| Study is available at: |
|
Pain Treatment Service, Children's Hospital
Boston, MA 02115
United States
Primary Contact:
Lisa Scharff, Ph.D.
Email: lisa.scharff@tch.harvard.edu
Phone: 617-355-2470 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 21, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|