Migraine and Recurrent Abdominal Pain in Children - Article Headache and Migraine; Migraine headache; Migraine Headaches
Clinical Trial: Migraine and Recurrent Abdominal Pain in Children
This study is currently recruiting patients.
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.
|Condition||Treatment or Intervention|
| Behavior: thermal biofeedback |
Behavior: relaxation training
Behavior: cognitive coping skills
Behavior: parent education
MedlinePlus related topics: Abdominal Pain; Migraine
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Treatment of Recurrent Pain Syndromes in Children
Expected Total Enrollment: 180
Study start: May 1999; Expected completion: June 2004
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.
Ages Eligible for Study: 7 Years - 17 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
- Migraine or functional abdominal pain of at least 3 months duration, occurring at least weekly or 5 days per month
- Child assent
- Parental consent
- 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)
Location and Contact Information
Pain Treatment Service, Children's Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Clorinda Schenck 617-355-8973 email@example.com
Lisa Scharff, Ph.D., Principal Investigator, Harvard University
Blanchard EB, Scharff L. Psychosocial aspects of assessment and treatment of irritable bowel syndrome in adults and recurrent abdominal pain in children. J Consult Clin Psychol. 2002 Jun;70(3):725-38. Review.
Record last reviewed: March 2003
Last Updated: October 13, 2004
Record first received: May 8, 2003
ClinicalTrials.gov Identifier: NCT00060619
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005