Combination Therapy with Simultaneous Delivery of Spinal Cord Stimulation Modalities: COMBO Randomized Controlled Trial

Figures & data

Figure 1. Study schematic for the Combining Mechanisms for Better Outcomes randomized controlled trial.

d: Days; Mo.: Month.

Figure 2. Illustrative depiction of neurostimulation field shapes.

(A) Produced by an 8 mm bipole configuration typical of conventional spinal cord stimulation and (B) algorithmic-based customized spinal cord stimulation configuration designed to more optimally provide for stimulation of the spinal dorsal horn.

Figure 3. Subject disposition.

A total of 174 subjects were enrolled, of whom 100 were implanted. A prespecified cohort of 89 randomized subjects were included in the interim analysis.

*Pre-specified cohort of 89 randomized subjects for analysis.

SCS: Spinal cord stimulation.

Table 1. Patient baseline characteristics and demographics.

Age (years): mean (SD), n	57.3 (11.86), 89
Gender (female): % (n/N)	65.2 (58/89)
Diagnosis for receiving the stimulator (may have multiple diagnosis):
Failed back surgery syndrome (%)	60.7
Radiculopathy (%)	22.5
Complex regional pain syndrome (%)	2.2
Other (%)	14.6
Average opioid medication (MME): mean (SD), n	31.8 (44.14), 89
Average low back pain (VRS): mean (SD), n	7.6 (1.0), 89
Average overall pain (VRS): mean (SD), n	7.4 (1.0), 89
Disability (Oswestry Disability Index): mean (SD), n	54.2 (8.9), 89
Duration of low back/leg pain (years): mean (SD), n	16.2 (13.0), 89

MME: Morphine milligram equivalents; SD: Standard deviation; VRS: Verbal Rating Scale.

Figure 4. Primary end point evaluation: proportion of subjects with 50% or greater reduction in overall pain at 3 months post-randomization with no increase in baseline average daily opioid medications.

Figure 5. Functional Disability and Patient Satisfaction.

(A) Mean improvement in Oswestry Disability Index score at 3 month follow-up. (B) Proportion of subjects who reported being ‘much’ or ‘very much’ improved at 3 month follow-up.

ODI: Oswestry Disability Index; PGIC: Patient Global Impression of Change.

Figure 6. Long-term follow-up (1 and 2 years).

(A) Responder rate. (B) Mean change in ODI scores versus baseline measurement. (C) Percentage of subjects reporting much or very much improved per PGIC.

ODI: Oswestry Disability Index; PGIC: Patient Global Impression of Change.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data of NCT01719055. Individual and deidentified participant data will not be available. The data, analytical methods and study materials for this clinical study will be made available to other researchers in accordance with Boston Scientific’s data sharing policy (https://www.bostonscientific.com).