Pediatric Pain Rehabilitation Program | NCT01340261

Studies
Pediatric Pain Rehabilitation Program

NCT01340261

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Dec 12, 2022Actual

Enrollment

975Actual

Phase

Not provided

Conditions

Pediatric Chronic Pain

Interventions

Questionnaires

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Apr 21, 2011

First Submission Date that Met QC Criteria

Apr 21, 2011

First Posted Date

Apr 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2022

Last Update Posted Date

Dec 12, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerard A. Banez, Pediatric Psychologist, Director of Pediatric Pain Rehabilitation Program, The Cleveland ClinicPrincipal Investigator

Lead Sponsor

The Cleveland ClinicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to describe the demographic, medical, and psychological/behavioral characteristics of children and adolescent patients admitted to the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program. The data will also be used to evaluate the clinical outcomes of patients admitted to the program as well as to examine the impact of various background factors on clinical outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

975Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric Pain Rehab Patients			Behavioral: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Behavioral	Questionnaires are completed at admission, discharge, 1-month, 6 month, and yearly follow-up.	Pediatric Pain Rehab Patients

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted into the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All participants admitted to the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program are eligible for enrollment in the registry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerard A Banez, PhD	Cleveland Clinic Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Children's Hospital for Rehabilitation		Cleveland	Ohio	44104	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided