Chronic PainSIMTAPNCT01186341
BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain
An observational study of Chronic Pain, run by Duke University at 9 sites in United States.
Trial summary
Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient Clinics indicate that pain was the leading reason for patient visits. As a precursor to a large multi-site clinical trial, this study aims to determine the feasibility of collecting outcomes data on integrative treatment for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 418 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2009to Jun 2011
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending one of the nine Integrative Medicine Clinics of the BraveNet research network.
Who may be able to join
- Subjects will be men and women aged 18 and over.
- Patient Status: Participants are eligible if they are new or existing patients of the center who are seeking their initial treatment at the Integrative Medicine center for chronic pain (chronic > 3 months) who report their average pain level over the past month to be at least a 4 of 10 on the VAS.
- English or Spanish Literacy: Ability to read and write English or Spanish as confirmed by the site personnel and ability to provide informed consent.
- Subject must provide written informed consent before initiation of any study-related procedures.
- Subject must be able to understand and comply with the requirements of the study, as judged by the investigator.
Who cannot join
- A subject will not be eligible if he/she is unable to provide Informed Consent.
- Inability to read and write in English or Spanish.
- Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the patients risk by participating in the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Maryland Center for Integrative Medicine
Baltimore, Maryland, 21207
Alliance Center for Integrative Medicine
Cincinnati, Ohio, 45236
Duke Integrative Medicine
Durham, North Carolina, 27705
Scripps Center for Integrative Medicine
La Jolla, California, 92037
Penny George Institute for Health and Healing
Minneapolis, Minnesota, 55407
The Continuum Center for Health and Healing
New York, New York, 10016
Jefferson-Myrna Brind Center of Integrative Medicine
Philadelphia, Pennsylvania, 19107
UCSF Osher Center for Integrative Medicine
San Francisco, California, 94143
Venice Family Clinic Simms/Mann Health and Wellness Center
Santa Monica, California, 90405
About this study
Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient Clinics indicate that pain was the leading reason for patient visits. As a precursor to a large multi-site clinical trial, this study aims to determine the feasibility of collecting outcomes data on integrative treatment for pain. These preliminary data will also provide an estimation of effect size for powering the multi-site clinical trial.
Read the detailed description
Integrative medicine (IM) provides a comprehensive approach to care in which healing and wellness of the whole person are the foremost goals. IM is not simply complementary and alternative medicine (CAM), but it stresses patient-centered, healing-oriented care that emphasizes the patient-caregiver relationship.
Little is known about the health outcomes of patients who present to an IM center and undergo a variety of treatment modalities to treat a specific condition. Adequately capturing and describing IM patient outcomes is a challenge for many reasons. First, given the whole person focus of IM, multiple domains of outcomes must be considered including physical, psychological, social, and spiritual. Second, since the patient-centric notion of individualized care is seminal to IM, IM outcomes must allow for patient-reported outcomes. Finally, the complexity of whole system care creates a natural barrier when measuring IM efficacy. Whole systems of care theoretically rely on synergistic and inseparable components and conceptualize the patient-practitioner interaction as a key component of care.
The Bravewell Integrative Medicine Research Network (BraveNet) is a practice-based research network of nine leading integrative medicine centers around the U.S. collaborating in clinical outcomes research to increase the knowledge and evidence-base of IM. These centers may differ in terms of patient population, medical conditions seen, IM services offered, and treatment outcomes, but all are committed to the provision of integrative care.
Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient Clinics indicate that pain was the leading reason for patient visits. As a precursor to a large multi-site clinical trial, this study aims to determine the feasibility of collecting outcomes data on integrative treatment for pain. These preliminary data will also provide an estimation of effect size for powering the multi-site clinical trial.
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain
- Medical subject headings
- Chronic Pain
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 |
|---|---|---|
| Chronic Pain | New or existing patients of the center who are seeking their initial treatment at the Integrative Medicine center for chronic pain (chronic > 3 months) who report their average pain level over the past month to be at least a 4 of 10 on the Visual Analog Scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of assessing the impact of IM intervention on chronic pain
As measured by the number of patients approached to participate, number who refuse to participate, reasons for refusal, and the number of people who provide consent.
Measured: 24 weeks
Secondary outcomes (7)
Quality of Life
As measured by self report on a questionnaire
Measured: 24 weeks
Sense of control
As measured by a Visual Analog Scale
Measured: 24 weeks
Depression and Stress
As measured by self report questionnaires such as the depression (The Center for Epidemiologic Studies Depression Scale (CES-D)and stress (The Perceived Stress Scale - 4)
Measured: 24 weeks
Inflammatory Marker and Vitamin D
High-sensitivity C reactive protein (hs-CRP) and 25-hydroxy-vitamin D levels at baseline and 12 weeks
Measured: 24 weeks
Health services utilization
As measured by self report of health services(including medications and supplements).
Measured: 24 weeks
Work productivity and activity impairment
As measured by the Work Productivity and Activity Impairment (WPAI) survey.
Measured: 24 weeks
Estimate the effect size of IM interventions for reducing pain in chronic pain patients
As measured by the Pain-Visual analog scale of average and worst pain and (total) Brief Pain Inventory (BPI) interference scale
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Bravewell Collaborative, Alliance Institute for Integrative Medicine, Allina Health System, University of Maryland, Beth Israel Medical Center, Thomas Jefferson University, University of California, San Francisco, Scripps Clinic, Venice Family Clinic
- Responsible party
- Sponsor
- Investigators
- Rowena Dolor, MD, Principal investigator, Duke Clinical Research InstituteRuth Wolever, PhD, Principal investigator, Duke Integrative Medicine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186341
- Sponsor's protocol ID
- Pro00018346
- Acronym
- SIMTAP
- Status last verified
- Jun 2011
- First submitted
- 19 Aug 2010
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Abrams DI, Dolor R, Roberts R, Pechura C, Dusek J, Amoils S, Amoils S, Barrows K, Edman JS, Frye J, Guarneri E, Kligler B, Monti D, Spar M, Wolever RQ. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013 Jun 24;13:146. doi: 10.1186/1472-6882-13-146.
PubMed 23800144
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain
- ClinicalTrials.gov ID
- NCT01186341
- Acronym / sponsor ID
- SIMTAP / Pro00018346
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Bravewell Collaborative, Alliance Institute for Integrative Medicine, Allina Health System, University of Maryland, Beth Israel Medical Center, Thomas Jefferson University, University of California, San Francisco, Scripps Clinic, Venice Family Clinic
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Aug 2010 (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.
Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient Clinics indicate that pain was the leading reason for patient visits. As a precursor to a large multi-site clinical trial, this study aims to determine the feasibility of collecting outcomes data on integrative treatment for pain. These preliminary data will also provide an estimation of effect size for powering the multi-site clinical trial.
Detailed description
Integrative medicine (IM) provides a comprehensive approach to care in which healing and wellness of the whole person are the foremost goals. IM is not simply complementary and alternative medicine (CAM), but it stresses patient-centered, healing-oriented care that emphasizes the patient-caregiver relationship.
Little is known about the health outcomes of patients who present to an IM center and undergo a variety of treatment modalities to treat a specific condition. Adequately capturing and describing IM patient outcomes is a challenge for many reasons. First, given the whole person focus of IM, multiple domains of outcomes must be considered including physical, psychological, social, and spiritual. Second, since the patient-centric notion of individualized care is seminal to IM, IM outcomes must allow for patient-reported outcomes. Finally, the complexity of whole system care creates a natural barrier when measuring IM efficacy. Whole systems of care theoretically rely on synergistic and inseparable components and conceptualize the patient-practitioner interaction as a key component of care.
The Bravewell Integrative Medicine Research Network (BraveNet) is a practice-based research network of nine leading integrative medicine centers around the U.S. collaborating in clinical outcomes research to increase the knowledge and evidence-base of IM. These centers may differ in terms of patient population, medical conditions seen, IM services offered, and treatment outcomes, but all are committed to the provision of integrative care.
Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient Clinics indicate that pain was the leading reason for patient visits. As a precursor to a large multi-site clinical trial, this study aims to determine the feasibility of collecting outcomes data on integrative treatment for pain. These preliminary data will also provide an estimation of effect size for powering the multi-site clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain | – | –New or existing patients of the center who are seeking their initial treatment at the Integrative Medicine center for chronic pain (chronic > 3 months) who report their average pain level over the past month to be at least a 4 of 10 on the Visual Analog Scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending one of the nine Integrative Medicine Clinics of the BraveNet research network.
Key inclusion criteria (5 listed)
- Subjects will be men and women aged 18 and over.
- Patient Status: Participants are eligible if they are new or existing patients of the center who are seeking their initial treatment at the Integrative Medicine center for chronic pain (chronic > 3 months) who report their average pain level over the past month to be at least a 4 of 10 on the VAS.
- English or Spanish Literacy: Ability to read and write English or Spanish as confirmed by the site personnel and ability to provide informed consent.
- Subject must provide written informed consent before initiation of any study-related procedures.
- Subject must be able to understand and comply with the requirements of the study, as judged by the investigator.
Key exclusion criteria (3 listed)
- A subject will not be eligible if he/she is unable to provide Informed Consent.
- Inability to read and write in English or Spanish.
- Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the patients risk by participating in the 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
To evaluate the feasibility of assessing the impact of IM intervention on chronic pain
Time frame: 24 weeks
As measured by the number of patients approached to participate, number who refuse to participate, reasons for refusal, and the number of people who provide consent.
7 secondary outcomes
Quality of Life
Time frame: 24 weeks
Sense of control
Time frame: 24 weeks
Depression and Stress
Time frame: 24 weeks
Inflammatory Marker and Vitamin D
Time frame: 24 weeks
Health services utilization
Time frame: 24 weeks
Work productivity and activity impairment
Time frame: 24 weeks
Estimate the effect size of IM interventions for reducing pain in chronic pain patients
Time frame: 24 weeks
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 26 Oct 2023.
- Derived from this study: PubMed 23800144Abrams DI, Dolor R, Roberts R, Pechura C, Dusek J, Amoils S, Amoils S, Barrows K, Edman JS, Frye J, Guarneri E, Kligler B, Monti D, Spar M, Wolever RQ. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013 Jun 24;13:146. doi: 10.1186/1472-6882-13-146.
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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.
Rowena Dolor, MD principal investigator
Duke Clinical Research Institute
Ruth Wolever, PhD principal investigator
Duke Integrative Medicine Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Duke University at 9 sites 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 5 inclusion and 3 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
To evaluate the feasibility of assessing the impact of IM intervention on chronic pain (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186341, which also lists 1 linked publication.
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 26 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.