The BraveNet prospective observational study on integrative medicine treatment approaches for pain

Abstract

Background: Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures.

Methods: Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks.

Results: Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (-23%) and interference (-28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12.

Conclusions: Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures.

Trial registration: ClinicalTrials.gov, NCT01186341.

Figures

Figure 1

Mosaic plot of Modalities received by Patients. The x-axis shows the number of modalities received and the width of the column is proportional to the number of patients in each category – 1 modality (n = 22 patients), 2 modalities (n = 50), 3 modalities (n = 50), 4 modalities (n = 52), 5 modalities (n = 42), 6 modalities (n = 19), 7 modalities (n = 5), all 8 modalities (n = 3). The y-axis shows the proportion of patients who received each modality; the actual percentages are included in each colored box (where feasible).

Figure 2

Repeated-measures analysis of primary outcome: Brief Pain Inventory (BPI) pain scores. Reported P values are overall model results summarizing any potential change across four time points throughout the study. Individual estimated change from baseline scores specify changes in scores from baseline to any designated study visit on a scale from 0 to 10, with 0 indicating least possible pain or interference.