BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP)
|ClinicalTrials.gov Identifier: NCT01186341|
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : March 26, 2015
|Condition or disease|
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|
|Actual Enrollment :||418 participants|
|Official Title:||BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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.
- 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.
- Quality of Life [ Time Frame: 24 weeks ]As measured by self report on a questionnaire
- Sense of control [ Time Frame: 24 weeks ]As measured by a Visual Analog Scale
- Depression and Stress [ Time Frame: 24 weeks ]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 ]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 ]As measured by self report of health services(including medications and supplements).
- Work productivity and activity impairment [ Time Frame: 24 weeks ]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 ]As measured by the Pain-Visual analog scale of average and worst pain and (total) Brief Pain Inventory (BPI) interference scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186341
|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|
|Principal Investigator:||Rowena Dolor, MD||Duke Clinical Research Institute|
|Principal Investigator:||Ruth Wolever, PhD||Duke Integrative Medicine Center|