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

• 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.
  
  

• 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
  
  

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.