BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP)

This study has been completed.
Sponsor:
Collaborators:
The Bravewell Collaborative
Alliance Institute for Integrative Medicine
Allina Hospitals and Clinics
University of Maryland
Beth Israel Medical Center
Thomas Jefferson University
University of California, San Francisco
Scripps Clinic
Venice Family Clinic
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT01186341
First received: August 19, 2010
Last updated: June 12, 2011
Last verified: June 2011
  Purpose

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.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To evaluate the feasibility of assessing the impact of IM intervention on chronic pain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    As measured by self report on a questionnaire

  • Sense of control [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    As measured by a Visual Analog Scale

  • Depression and Stress [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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)

  • Inflammatory Marker and Vitamin D [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    High-sensitivity C reactive protein (hs-CRP) and 25-hydroxy-vitamin D levels at baseline and 12 weeks

  • Health services utilization [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    As measured by self report of health services(including medications and supplements).

  • Work productivity and activity impairment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    As measured by the Work Productivity and Activity Impairment (WPAI) survey.

  • Estimate the effect size of IM interventions for reducing pain in chronic pain patients [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    As measured by the Pain-Visual analog scale of average and worst pain and (total) Brief Pain Inventory (BPI) interference scale


Enrollment: 418
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients attending one of the nine Integrative Medicine Clinics of the BraveNet research network.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186341

Locations
United States, California
Scripps Center for Integrative Medicine
La Jolla, California, United States, 92037
UCSF Osher Center for Integrative Medicine
San Francisco, California, United States, 94143
Venice Family Clinic Simms/Mann Health and Wellness Center
Santa Monica, California, United States, 90405
United States, Maryland
University of Maryland Center for Integrative Medicine
Baltimore, Maryland, United States, 21207
United States, Minnesota
Penny George Institute for Health and Healing
Minneapolis, Minnesota, United States, 55407
United States, New York
The Continuum Center for Health and Healing
New York, New York, United States, 10016
United States, North Carolina
Duke Integrative Medicine
Durham, North Carolina, United States, 27705
United States, Ohio
Alliance Center for Integrative Medicine
Cincinnati, Ohio, United States, 45236
United States, Pennsylvania
Jefferson-Myrna Brind Center of Integrative Medicine
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Duke University
The Bravewell Collaborative
Alliance Institute for Integrative Medicine
Allina Hospitals and Clinics
University of Maryland
Beth Israel Medical Center
Thomas Jefferson University
University of California, San Francisco
Scripps Clinic
Venice Family Clinic
Investigators
Principal Investigator: Rowena Dolor, MD Duke Clinical Research Institute
Principal Investigator: Ruth Wolever, PhD Duke Integrative Medicine Center
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rowena Dolor, MD, Duke Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01186341     History of Changes
Other Study ID Numbers: Pro00018346
Study First Received: August 19, 2010
Last Updated: June 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Chronic Pain

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014