1. 2011;14;525-530Use of Observational Mechanical Gateway Connector in Spinal Cord Stimulation Trials
   Retrospective Evaluation
   Chong H. Kim , MD, Mohammed A. Issa, MD, and Richard M. Vaglienti, MD.

BACKGROUND: Spinal cord stimulation (SCS) is an established treatment option for chronic pain. Prior to permanent implantation, temporary trials are performed to evaluate the SCS treatment. Currently there are multiple manufacturers with varying fundamental differences in delivery and resultant paresthesias. However, trials are typically limited to one manufacturer for the patient to evaluate.

OBJECTIVE: To evaluate the role of the Observational Mechanical Gateway (OMG) Connector for patients undergoing SCS trials.

STUDY DESIGN: Retrospective cohort design study. Patients undergoing SCS trials were offered at the end of the 7 day trial to experience stimulation using the OMG Connector.

SETTING: Academic university-based pain management center.

METHOD: Participants were trialed using the OMG Connector at the end of the 7 day spinal cord stimulation trial. Data based on participants’ preference were collected.

RESULTS: The average pain score at baseline was 7.3 on a 10-point scale overall, with improvement during the SCS trial to 2.9 overall; 3.5 in Medtronic (MT); and 2.4 in St. Jude (SJ) SCS trials (P = 0.04). The average pain score with OMG was 2.6 overall; 2.8 in MT; and 2.4 in SJ (P = 0.28). In terms of overall coverage of pain distribution, paresthesia and overall satisfaction, the P values were 0.24, 0.21 and 0.33 respectively. Overall, 12 of 16 participants underwent permanent implantation. One of the 4 failed trials was successfully retrialed with the OMG Connector.

LIMITATIONS:  Small sample of participants and the duration of the OMG Connector trial.

CONCLUSIONS: The OMG Connector offers patients another opportunity to better access the available treatment options during the SCS trial period.