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Randomized Controlled Trial
. 2021 Apr;24(3):448-458.
doi: 10.1111/ner.13358. Epub 2021 Jan 18.

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

Angeles Canós-Verdecho  1   2 , David Abejón  3 , Ruth Robledo  1   2 , Rosa Izquierdo  1   2 , Ara Bermejo  1 , Elisa Gallach  1   4 , Pilar Argente  2   5 , Isabel Peraita-Costa  6   7 , María Morales-Suárez-Varela  6   7
Affiliations
Randomized Controlled Trial

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

Angeles Canós-Verdecho et al. Neuromodulation. 2021 Apr.

Abstract

Objective: 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.

Materials and methods: 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).

Results: 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.

Conclusions: 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.

Keywords: Complex regional pain syndrome; high-frequency 10 kHz (10 kHz); neuromodulation; pain management; spinal cord stimulation.

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