Osteoarthritis of the KneeEFPNCT02195674
EMBARK Follow-up Project
An observational study of Osteoarthritis of the Knee, run by Duke University.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the EMBARK parent study.
Who may be able to join
- Completed in the EMBARK parent study.
Who cannot join
- Did not complete the EMBARK parent study.
About this study
Official title: Exploring Massage Benefits for Arthritis of the Knee (EMBARK): Post-study Massage Questionnaire
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.
- Conditions
- Osteoarthritis of the Knee
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Adam I Perlman, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195674
- Sponsor's protocol ID
- Pro00054004
- Other IDs
- 3R01AT004623-06S2
- Acronym
- EFP
- Status last verified
- Oct 2015
- First submitted
- 18 Jul 2014
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Massage Benefits for Arthritis of the Knee (EMBARK): Post-study Massage Questionnaire
- ClinicalTrials.gov ID
- NCT02195674
- Acronym / sponsor ID
- EFP / Pro00054004
- Conditions
- Osteoarthritis of the Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the EMBARK parent study.
Key inclusion criteria (1 listed)
- Completed in the EMBARK parent study.
Key exclusion criteria (1 listed)
- Did not complete the EMBARK parent study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EMBARK Follow-up Project Questionnaire (EFPQ)
Time frame: Eight weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam I Perlman, MD, MPH principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Knee, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMBARK Follow-up Project Questionnaire (EFPQ) (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.