EMBARK Follow-up Project | NCT02195674

Studies
EMBARK Follow-up Project

NCT02195674

Sponsor

Duke University

Status

Completed

Last Update Posted

Nov 16, 2015Estimated

Enrollment

240Estimated

Phase

Not provided

Conditions

Osteoarthritis of the Knee

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
3R01AT004623-06S2	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2015

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

Apr 2013

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jul 18, 2014

First Submission Date that Met QC Criteria

Jul 18, 2014

First Posted Date

Jul 21, 2014Estimated

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

Nov 12, 2015

Last Update Posted Date

Nov 16, 2015Estimated

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

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 the EMBARK Follow-up Project (EFP) is to determine if there is a significant correlation between post-study massage-seeking and changes in pain reported by participants during the Exploring Massage Benefits for Osteoarthritis of the Knee (EMBARK) parent study (NCT00970008). The EFP hypothesizes that a positive correlation exists between pain relief during the parent study and post-study massage-seeking behavior.

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

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

240Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EMBARK Follow-up Project Questionnaire (EFPQ)	The EFPQ is an original set of questions, designed and validated by Dr. Jerger under the supervision of NCCAM and Dr. Ruth Wolever to be administered by email or phone to address the specific aims of this project.	Eight weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completed in the EMBARK parent study.

Exclusion Criteria:

Did not complete the EMBARK parent study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants in the EMBARK parent study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam I Perlman, MD, MPH	Duke University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided