Clinical Trial: Migraine and Recurrent Abdominal Pain in Children

This study is currently recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

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 Treatment or Intervention
Migraine
Abdominal Pain
 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

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  7 Years   -   17 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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)

Location and Contact Information


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

Study chairs or principal investigators

Lisa Scharff, Ph.D.,  Principal Investigator,  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.

Study ID Numbers:  5R01HD38647-3
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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