CLINICAL OUTCOMES: PROCESS STUDY SPINAL CORD STIMULATION

PROCESS STUDY

The Medtronic (MDT) PROCESS Study is the first randomised, controlled, multicentre 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 randomised to MDT SCS+CMM and 1 (2%) randomised 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 randomised. 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

Percentage of Patients Achieving ≥ 30% Leg Pain Relief at 24 Months (n=42)

For insights, click here to visit the clinical review report. 

IMPROVED FUNCTIONAL CAPACITY

ADVERSE EVENTS

See the device/therapy manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events, If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.

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

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