Randomized Prospective Study in Patients with Complex Regional Pain Syndrome of the Upper Limb with High-Frequency Spinal Cord Stimulation (10-kHz) and Low-Frequency Spinal Cord Stimulation

Canós-Verdecho, A.; Abejón, D.; Robledo, R.; Izquierdo, R.; Bermejo, A.; Gallach, E.; Argente, P.; Peraita-Costa, I.; Morales-Suárez-Varela, M.ía.

Neuromodulation Journal of the International Neuromodulation Society 24(3): 448-458

2021


ISSN/ISBN: 1525-1403
PMID: 33462916
DOI: 10.1111/dth.14148
Accession: 080335851

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Abstract
The objective of this prospective randomized study of cases and controls was to evaluate the efficacy of treatment with low-frequency spinal cord stimulation (LF-SCS) and 10 kHz spinal cord stimulation (10-kHz SCS) in patients diagnosed with complex regional pain syndrome type I (CRPS) with upper limb involvement. Fifty patients were randomized to receive conventional treatment or SCS with a commercially available low-frequency or 10-kHz system. Patients were assessed at 1, 3, 6, and 12 months. The primary endpoint was at 12-months post permanent implantation of the SCS devices. Outcome measures assessed included: Numerical Rating Scale (NRS), 12-Item Short-Format Health Survey (SF-12), Oswestry Disability Index (ODI), Study Sleep Scale medical outcomes (MOS-SS), Douleur Neuropathique 4 questions pain questionnaire (DN4), Patient Global Impression Scale on the impact of treatment improvement (PGI-I), Clinician Global Impression Scale on the impact of improving the patient (CGI-I). Forty-one patients were finally included in the analysis, 19 patients in the conventional treatment group, 12 in the LF-SCS group, and 10 in the 10-kHz SCS group. At the primary endpoint, patients treated with LF-SCS presented improvements in the NRS and DN4 outcomes around 2.4 and 1.5 times above the minimal clinically important difference (MCID) thresholds. At the primary endpoint, patients treated with 10-kHz SCS presented improvements in the NRS and DN4 outcomes around 2 and 1.4 times above the MCID thresholds. Patients experienced considerable improvement after SCS. The results show that LF-SCS has very good results when compared with conventional treatment. The results obtained with 10-kHz SCS are encouraging, with the advantages of the absence of paresthesia making it an alternative in the treatment of CRPS.