PMID- 33462918 OWN - NLM STAT- MEDLINE DCOM- 20210818 LR - 20220210 IS - 1525-1403 (Electronic) IS - 1094-7159 (Linking) VI - 24 IP - 3 DP - 2021 Apr TI - 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. PG - 448-458 LID - 10.1111/ner.13358 [doi] AB - 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. CI - (c) 2021 International Neuromodulation Society. FAU - Canos-Verdecho, Angeles AU - Canos-Verdecho A AD - Multidisciplinary Pain Management Unit, Hospital Universitari i Politecnic La Fe, Valencia, Spain. AD - Anaesthesiology Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain. FAU - Abejon, David AU - Abejon D AD - Multidisciplinary Pain Management Unit, Hospital Universitario Quironsalud, Madrid, Spain. FAU - Robledo, Ruth AU - Robledo R AD - Multidisciplinary Pain Management Unit, Hospital Universitari i Politecnic La Fe, Valencia, Spain. AD - Anaesthesiology Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain. FAU - Izquierdo, Rosa AU - Izquierdo R AD - Multidisciplinary Pain Management Unit, Hospital Universitari i Politecnic La Fe, Valencia, Spain. AD - Anaesthesiology Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain. FAU - Bermejo, Ara AU - Bermejo A AD - Multidisciplinary Pain Management Unit, Hospital Universitari i Politecnic La Fe, Valencia, Spain. FAU - Gallach, Elisa AU - Gallach E AD - Multidisciplinary Pain Management Unit, Hospital Universitari i Politecnic La Fe, Valencia, Spain. AD - Psychiatry Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain. FAU - Argente, Pilar AU - Argente P AD - Anaesthesiology Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain. AD - Surgical Specialities Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain. FAU - Peraita-Costa, Isabel AU - Peraita-Costa I AUID- ORCID: 0000-0002-4148-6161 AD - Unit of Preventive Medicine and Public Health, Department of Preventive Medicine and Public Health, Food Sciences, Toxicology and Forensic Medicine, Universitat de Valencia, Valencia, Spain. AD - CIBER Epidemiology and Public Health (CIBERESP). The Institute of Health Carlos III (ISCIII), Madrid, Spain. FAU - Morales-Suarez-Varela, Maria AU - Morales-Suarez-Varela M AUID- ORCID: 0000-0003-0785-1492 AD - Unit of Preventive Medicine and Public Health, Department of Preventive Medicine and Public Health, Food Sciences, Toxicology and Forensic Medicine, Universitat de Valencia, Valencia, Spain. AD - CIBER Epidemiology and Public Health (CIBERESP). The Institute of Health Carlos III (ISCIII), Madrid, Spain. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20210118 PL - United States TA - Neuromodulation JT - Neuromodulation : journal of the International Neuromodulation Society JID - 9804159 SB - IM MH - *Chronic Pain MH - *Complex Regional Pain Syndromes/therapy MH - Humans MH - Pain Measurement MH - Prospective Studies MH - Spinal Cord MH - *Spinal Cord Stimulation MH - Treatment Outcome MH - Upper Extremity OTO - NOTNLM OT - Complex regional pain syndrome OT - high-frequency 10 kHz (10 kHz) OT - neuromodulation OT - pain management OT - spinal cord stimulation EDAT- 2021/01/20 06:00 MHDA- 2021/08/19 06:00 CRDT- 2021/01/19 06:03 PHST- 2020/12/11 00:00 [revised] PHST- 2020/10/26 00:00 [received] PHST- 2020/12/15 00:00 [accepted] PHST- 2021/01/20 06:00 [pubmed] PHST- 2021/08/19 06:00 [medline] PHST- 2021/01/19 06:03 [entrez] AID - S1094-7159(21)00057-X [pii] AID - 10.1111/ner.13358 [doi] PST - ppublish SO - Neuromodulation. 2021 Apr;24(3):448-458. doi: 10.1111/ner.13358. Epub 2021 Jan 18.