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High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Abdominal Pain: Interim Results from a Multicenter Feasibility Study
Session: MP-03b
Thurs, Nov. 16, 1:30-3:30 pm
Saybrook Room

Please note, medically challenging cases are removed three months after the meeting and scientific abstracts after three years.

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Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Abdominal Pain:  Interim Results from a Multicenter Feasibility Study

Introduction:

-Chronic abdominal pain (CAP): debilitating condition, challenging to treat

-Opioids, sympathetic nerve blocks, and radiofrequency ablation do not resolve pain in many patients

-Traditional spinal cord stimulation has been tried in this patient group; retrospective analysis shows some long term success.1,2,3,4

-High frequency cord stimulation (HF-SCS) at 10 kHz spinal has the potential to increase patient satisfaction because of better pain relief outcomes and the absence of stimulation-induced paresthesias.

Objective: To determine efficacy, safety, and quality of life outcomes in the treatment of CAP with HF-SCS (Senza system,  Nevro Corp., Redwood City, CA), in a prospective single arm, multicenter study

-FDA granted an Investigational Device Exemption and institutional review board approval was obtained at four US centers. Participants who met inclusion/exclusion (Fig 1A) signed informed consent.. 

-If pain relief was achieved in the temporary trial, then subjects were implanted with a HF-SCS system. Lead placement shown in Fig 1B, plus a subcutaneously implanted stimulator. 

-Pain, symptoms and quality of life assessed at Baseline, 1, and 3 months. 

Results:

Twenty subjects have undergone temporary trial, none having previous SCS. Baseline characteristics are shown in Table 1.  Interim results are presented for all implanted subjects.  The number of subjects who have reached each study time point is shown in Table 2.  Ninety-five percent (19/20) achieved successful pain relief during temporary trial, eighteen of those underwent HF-SCS implantation, and one is scheduled for implant. 

The average abdominal pain intensity was reduced by 70% at 3 month post-implant with an 76% responder rate (Figure 2).  The individual responses to the therapy at 3 months are shown in Figure 3.  Responders achieved ≥ 50% pain relief. 

Individual response shown in Figure 3. Over half of the subjects (54%) achieved > 80% relief.  Success does not appear to be dependent on etiology.  Diagnoses for the trial failure and the two who failed to respond at 3 month included gastroparesis with chronic post-surgical pain (1), chronic pancreatitis (1), and chronic post-surgical pain (1).

Conclusions:

Interim results suggest that HF-SCS may be an effective tool for the treatment of CAP, successfully treating 77% of participants at 3 month, with 54% achieving ≥80% pain relief. 

Long term data must be analyzed to better measure the true efficacy of this therapy.

HF-SCS appears to be therapeutic for a range of visceral pathologies. Future studies of predictive clinical features for good therapeutic response with SCS would be valuable.

References:

1. Kapural L, Deer T, Yakovlev A et al. Pain Med. 2010;11(5):685-91.

2. Khan YN, Raza SS, Khan EA. Pain Medicine. 2006;7:S121-S5.

3. Kapural L, Cywinski JB, Sparks DA Neuromodulation. 2011;14(5):423-6; discussion 6-7.

4. Baranidharan G, Simpson KH, Dhandapani K. Neuromodulation. 2014;17(8):753-8; discussion 8.


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