Back Pain Lower Back ChronicNCT01355237
Observational Cohort Study of Chronic Low Back Pain
An observational study of Back Pain Lower Back Chronic, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. The investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 175 Osher… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The CLBP patients will be identified from two different sources at Brigham and Women's Hospital (BWH): those coming to be treated at the OCC, and those coming to non-OCC physician providers at BWH (comparison group).
Who may be able to join
- 3 months or more of chronic low back pain or 6 months or more of intermittent low back pain OR
- having at least one of a list of ICD-9 diagnostic codes for uncomplicated low back pain
- having two or more visits for back pain within the past two years; one of these visits must have happened within the past year (as a screening marker of chronicity)
Who cannot join
- under the age of 21
- unable to understand English
- have complicated low back pain (e.g. history of back pain related to cancer, fracture, or infection)
- unable to participate in the phone follow-up for the next one-year period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study II - Observational Cohort Study of Chronic Low Back Pain
This research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. The investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 175 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 175 non-OCC CLBP patients treated within Brigham and Women's Hospital. Outcomes will include assessment of functional status, symptom relief, satisfaction with care, health-related quality of life, and worker productivity, and will be measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3, 6, and 12 months.
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Complementary and alternative medicine (CAM)
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 |
|---|---|---|
| OCC Patients | Patients being treated for chronic low back pain at the Osher Clinical Center of Brigham and Women's Hospital | |
| Comparison | Patients being treated for chronic low back pain at Brigham and Women's Hospital, other than at Osher Clinical Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional disability related to low back pain
Measured by change in Modified Roland Morris disability scale (0-23 points)
Measured: 6 months
Change in Bothersomeness of pain
Measured by change in bothersomeness scale (On a scale of 0-10)
Measured: 6 months
Secondary outcomes (1)
Cost-effectiveness of integrative care for chronic low back pain
Measured by utilization of health care services and productivity in the workplace
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startFeb 2012
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Julie E. Buring, Brigham and Women's Hospital
- Investigators
- Julie E Buring, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355237
- Sponsor's protocol ID
- 1R01AT005065-01A1-2
- Other IDs
- 1R01AT005065-01A1
- Status last verified
- Jun 2017
- First submitted
- 12 May 2011
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study II - Observational Cohort Study of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01355237
- Acronym / sponsor ID
- 1R01AT005065-01A1-2
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Complementary and alternative medicine (CAM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center
- Study start
- Feb 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 May 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.
This research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. The investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 175 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 175 non-OCC CLBP patients treated within Brigham and Women's Hospital. Outcomes will include assessment of functional status, symptom relief, satisfaction with care, health-related quality of life, and worker productivity, and will be measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3, 6, and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCC Patients | – | –Patients being treated for chronic low back pain at the Osher Clinical Center of Brigham and Women's Hospital |
| Comparison | – | –Patients being treated for chronic low back pain at Brigham and Women's Hospital, other than at Osher Clinical Center |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The CLBP patients will be identified from two different sources at Brigham and Women's Hospital (BWH): those coming to be treated at the OCC, and those coming to non-OCC physician providers at BWH (comparison group).
Key inclusion criteria (3 listed)
- 3 months or more of chronic low back pain or 6 months or more of intermittent low back pain OR
- having at least one of a list of ICD-9 diagnostic codes for uncomplicated low back pain
- having two or more visits for back pain within the past two years; one of these visits must have happened within the past year (as a screening marker of chronicity)
Key exclusion criteria (4 listed)
- under the age of 21
- unable to understand English
- have complicated low back pain (e.g. history of back pain related to cancer, fracture, or infection)
- unable to participate in the phone follow-up for the next one-year period.
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
Change in functional disability related to low back pain
Time frame: 6 months
Measured by change in Modified Roland Morris disability scale (0-23 points)
Change in Bothersomeness of pain
Time frame: 6 months
Measured by change in bothersomeness scale (On a scale of 0-10)
1 secondary outcome
Cost-effectiveness of integrative care for chronic low back pain
Time frame: 12 months
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 14 Jun 2017.
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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.
Julie E Buring, ScD principal investigator
Brigham and Women's 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 Back Pain Lower Back Chronic, run by Brigham and Women's 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 4 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 14 Jun 2017. 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.
What does the primary outcome measure?
Change in functional disability related to low back pain (time frame: 6 months). The study lists 2 primary outcomes in all. 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 14 Jun 2017.