NCT00060619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2003

First QC Date

May 8, 2003

Last Update Submit

June 23, 2005

Conditions

MigraineAbdominal Pain

Keywords

MigraineFunctional abdominal painBiofeedbackPsychological assessment

Interventions

thermal biofeedbackBEHAVIORAL
relaxation trainingBEHAVIORAL
cognitive coping skillsBEHAVIORAL
parent educationBEHAVIORAL

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Migraine or functional abdominal pain of at least 3 months duration, occurring at least weekly or 5 days per month
  • Child assent
  • Parental consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Treatment Service, Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 12090379BACKGROUND

  • 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.

    PMID: 11821495BACKGROUND

  • 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.

    PMID: 11743510BACKGROUND

MeSH Terms

Conditions

Migraine DisordersAbdominal Pain

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lisa Scharff, Ph.D.

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 8, 2003

First Posted

May 12, 2003

Study Start

May 1, 1999

Study Completion

June 1, 2004

Last Updated

June 24, 2005

Record last verified: 2003-03

Locations

US(1)