CLINICAL OUTCOMES: PROCESS STUDY SPINAL CORD STIMULATION

PROCESS STUDY

The Medtronic (MDT) PROCESS Study is the first randomized, controlled, multicenter trial comparing the effectiveness of spinal cord stimulation (SCS) plus conventional medical management (CMM) versus CMM alone.

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Clinically Significant Leg Pain Relief

LEG PAIN RELIEF (≥ 50%) AT 6 MONTHS1

24 (48%) patients achieved the primary outcome of ≥ 50% leg pain relief as compared to 4 (9%) patients in the CMM alone group (p < 0.001).

PROCESS Study Results - Leg Pain Relief at 6 Months

 

NOTE: With the VAS, patients rate level of pain on a scale from 0 (no pain) to 10 (worst possible pain); the scores are then graded and given a percentage score.


LEG PAIN RELIEF (≥ 50%) AT 24 MONTHS2

In an as treated analysis2, 34 (47%) patients who received MDT SCS+CMM achieved the primary outcome versus 1 (7%) who received CMM along (p = 0.02).

In a modified ITT analysis2, 17 (37%) patients randomized to MDT SCS+CMM and 1 (2%) randomized to CMM alone achieved the primary outcome of ≥ 50% leg pain relief (p = 0.003).

PROCESS Study Results - Leg Pain Relief at 24 Months

 

NOTE: An ITT analysis compares all data from patients in the groups to which they were randomized. The modified ITT means that for all patients who requested to cross over; at 6 months, they were considered to have < 50% pain relief. An as treated analysis compares the groups based on the treatment the patient is receiving at the time of the visit.


LEG PAIN RELIEF: VAS SCORES FROM BASELINE TO 24 MONTHS (N = 42)2

Compared to baseline, the 42 patients continuing MDT SCS+CMM experienced statistically significantly lower levels of leg pain (P < 0.0001).

Leg Pain VAS Scores from Baseline to 24 Months


LEG PAIN RELIEF (≥ 30%): PATIENTS CONTINUING MDT SCS+CMM AT 24 MONTHS

69% of the 42 MDT SCS+CMM patients continuing therapy achieved (≥ 30%) leg pain relief.3

 

NOTE: A 30% reduction in pain is clinically meaningful.4

IMPROVED FUNCTIONAL CAPACITY

ADVERSE EVENTS


1

Kumar K, Taylor RS, Jacques L et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain 2007;132:179-188.

2

Kumar, et. al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4)762-770.

3

Cruccu G, Anand P, Attal N, et al. EFNS guidelines on neuropathic pain assessment. Eur J Neurol. 2004;11:153-162.

4

Teng J, Mekhail N. Neuropathic pain: mechanisms and treatment options. Pain Practice. 2003;3(1):8-21.

5

Fairbank JC, Couper J, Davies JB, O’Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271-273.