Migraine and Recurrent Abdominal Pain in Children
Primary Purpose
Migraine, Abdominal Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
thermal biofeedback
relaxation training
cognitive coping skills
parent education
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Functional abdominal pain, Biofeedback, Psychological assessment
Eligibility 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)
Sites / Locations
- Pain Treatment Service, Children's HospitalRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00060619
First Posted
May 8, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00060619
Brief Title
Migraine and Recurrent Abdominal Pain in Children
Official Title
Treatment of Recurrent Pain Syndromes in Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2003
Overall Recruitment Status
Unknown status
Study Start Date
May 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Abdominal Pain
Keywords
Migraine, Functional abdominal pain, Biofeedback, Psychological assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
thermal biofeedback
Intervention Type
Behavioral
Intervention Name(s)
relaxation training
Intervention Type
Behavioral
Intervention Name(s)
cognitive coping skills
Intervention Type
Behavioral
Intervention Name(s)
parent education
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Scharff, Ph.D.
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Treatment Service, Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Scharff, Ph.D.
Phone
617-355-2470
Email
lisa.scharff@tch.harvard.edu
First Name & Middle Initial & Last Name & Degree
Clorinda Schenck
Phone
617-355-8973
Email
clorinda.schenck@tch.harvard.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
12090379
Citation
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. doi: 10.1037//0022-006x.70.3.725.
Results Reference
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PubMed Identifier
11821495
Citation
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. doi: 10.1093/jpepsy/27.2.109.
Results Reference
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PubMed Identifier
11743510
Citation
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. doi: 10.1067/mpd.2001.118883.
Results Reference
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Migraine and Recurrent Abdominal Pain in Children
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