Migraine and Recurrent Abdominal Pain in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ClinicalTrials.gov Identifier:

NCT00060619

First received: May 8, 2003

Last updated: June 23, 2005

Last verified: March 2003

History of Changes

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.

Condition	Intervention
Migraine Abdominal Pain	Behavioral: thermal biofeedback Behavioral: relaxation training Behavioral: cognitive coping skills Behavioral: parent education


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Treatment of Recurrent Pain Syndromes in Children

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain Migraine

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):


Estimated Enrollment:	180
Study Start Date:	May 1999
Estimated Study Completion Date:	June 2004

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	7 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060619

Locations


United States, Massachusetts
Pain Treatment Service, Children's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Scharff, Ph.D. 617-355-2470 lisa.scharff@tch.harvard.edu
Contact: Clorinda Schenck 617-355-8973 clorinda.schenck@tch.harvard.edu

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators


Principal Investigator:	Lisa Scharff, Ph.D.	Harvard University

More Information

Publications:

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.

Scharff L, Marcus DA, Masek BJ. A controlled study of minimal-contact thermal biofeedback treatment in children with migraine. J Pediatr Psychol. 2002 Mar;27(2):109-19.

Di Lorenzo C, Youssef NN, Sigurdsson L, Scharff L, Griffiths J, Wald A. Visceral hyperalgesia in children with functional abdominal pain. J Pediatr. 2001 Dec;139(6):838-43.


ClinicalTrials.gov Identifier:	NCT00060619 History of Changes
Other Study ID Numbers:	5R01HD38647-3
Study First Received:	May 8, 2003
Last Updated:	June 23, 2005

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):


Migraine Functional abdominal pain Biofeedback Psychological assessment

Additional relevant MeSH terms:


Migraine Disorders Abdominal Pain Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on July 18, 2017

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