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

August 19, 2010
June 12, 2011
June 2009
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01186341 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain
BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Chronic Pain
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
418
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01186341
Pro00018346
No
Rowena Dolor, MD, Duke Clinical Research Institute
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
Principal Investigator: Rowena Dolor, MD Duke Clinical Research Institute
Principal Investigator: Ruth Wolever, PhD Duke Integrative Medicine Center
Duke University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP