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

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 Overview

• Status: Completed
• Conditions: Chronic Pain

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 Type: Observational
• Enrollment (Actual): 418

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Center for Integrative Medicine
    • San Francisco, California, United States, 94143
      • UCSF Osher Center for Integrative Medicine
    • Santa Monica, California, United States, 90405
      • Venice Family Clinic Simms/Mann Health and Wellness Center
  • Maryland
    • Baltimore, Maryland, United States, 21207
      • University of Maryland Center for Integrative Medicine
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Penny George Institute for Health and Healing
  • New York
    • New York, New York, United States, 10016
      • The Continuum Center for Health and Healing
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Integrative Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Alliance Center for Integrative Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson-Myrna Brind Center of Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	As measured by self report on a questionnaire	24 weeks
Sense of control	As measured by a Visual Analog Scale	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)	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	24 weeks
Health services utilization	As measured by self report of health services(including medications and supplements).	24 weeks
Work productivity and activity impairment	As measured by the Work Productivity and Activity Impairment (WPAI) survey.	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	24 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of Maryland; University of California, San Francisco; Beth Israel Medical Center; Thomas Jefferson University; Allina Health System; The Bravewell Collaborative; Alliance Institute for Integrative Medicine; Venice Family Clinic; Scripps Clinic
• Investigators: Principal Investigator: Rowena Dolor, MD, Duke Clinical Research Institute; Principal Investigator: Ruth Wolever, PhD, Duke Integrative Medicine Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (Estimated): August 23, 2010

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Chronic Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Pro00018346