Non-traumatic and Traumatic Health IssuesNCT01393262
Orthopaedic Hand Service Data Repository
An observational study of Non-traumatic and Traumatic Health Issues, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the research is to investigate multiple facets of non-traumatic and traumatic health issues. The majority of our research deals with mind-body aspects of health. The investigators often correlate different psychological measures against one another or match psychological and depression scores against… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-traumatic and Traumatic Health Issues
- How many people
- 9,620 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All individuals will be over the age of 18 and English speaking, excluding vulnerable populations (mental disabilities, prisoners etc.). Patients may be traumatic or non-traumatic.
Who may be able to join
- Over 18 years
- Patients presenting to Hand Service for traumatic or non-traumatic issues.
- English Speaking
Who cannot join
- under 18 years
- vulnerable population
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of the research is to investigate multiple facets of non-traumatic and traumatic health issues. The majority of our research deals with mind-body aspects of health. The investigators often correlate different psychological measures against one another or match psychological and depression scores against standard of care objective measurements (grip strength and range of motion).
The data repository also serves to streamline our studies and amalgamate many studies that are no more than minimal risk and do not involve randomization in any way.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Escort | Not described | |
| Hand Service patient | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startNov 2009
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-traumatic and Traumatic Health IssuesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Enrolment
- 9,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Chung-Jen Chen, Massachusetts General Hospital
- Investigators
- Neal Chen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393262
- Sponsor's protocol ID
- 2009-P-001019
- Status last verified
- Jan 2021
- First submitted
- 11 Jul 2011
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopaedic Hand Service Data Repository
- ClinicalTrials.gov ID
- NCT01393262
- Acronym / sponsor ID
- 2009-P-001019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,620 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 13 Jul 2011 (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 research is to investigate multiple facets of non-traumatic and traumatic health issues. The majority of our research deals with mind-body aspects of health. The investigators often correlate different psychological measures against one another or match psychological and depression scores against standard of care objective measurements (grip strength and range of motion).
The data repository also serves to streamline our studies and amalgamate many studies that are no more than minimal risk and do not involve randomization in any way.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Escort | – | – |
| Hand Service patient | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals will be over the age of 18 and English speaking, excluding vulnerable populations (mental disabilities, prisoners etc.). Patients may be traumatic or non-traumatic.
Key inclusion criteria (3 listed)
- Over 18 years
- Patients presenting to Hand Service for traumatic or non-traumatic issues.
- English Speaking
Key exclusion criteria (2 listed)
- under 18 years
- vulnerable population
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
Not reported in the source record.
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 12 Jan 2021.
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.
Neal Chen, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-traumatic and Traumatic Health Issues, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 2 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 12 Jan 2021.