Details

Autor(en) / Beteiligte

• Petersen, Erika A.
• Stauss, Thomas G.
• Scowcroft, James A.
• Brooks, Elizabeth S.
• White, Judith L.
• Sills, Shawn M.
• Amirdelfan, Kasra
• Guirguis, Maged N.
• Xu, Jijun
• Yu, Cong
• Nairizi, Ali
• Patterson, Denis G.
• Tsoulfas, Kostandinos C.
• Creamer, Michael J.
• Galan, Vincent
• Bundschu, Richard H.
• Mehta, Neel D.
• Sayed, Dawood
• Lad, Shivanand P.
• DiBenedetto, David J.
• Sethi, Khalid A.
• Goree, Johnathan H.
• Bennett, Matthew T.
• Harrison, Nathan J.
• Israel, Atef F.
• Chang, Paul
• Wu, Paul W.
• Argoff, Charles E.
• Nasr, Christian E.
• Taylor, Rod S.
• Caraway, David L.
• Mekhail, Nagy A.

Titel

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial

Ist Teil von

• Mayo Clinic proceedings. Innovations, quality & outcomes, 2022-08, Vol.6 (4), p.347-360

Ort / Verlag

Netherlands: Elsevier Inc

Erscheinungsjahr

2022

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy. A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months. The participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were “satisfied” or “very satisfied” with the 10-kHz SCS treatment. The 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy. clincaltrials.gov Identifier: NCT03228420