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10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience
- Source :
- European Spine Journal. 29:2786-2794
- Publication Year :
- 2020
- Publisher :
- Springer Science and Business Media LLC, 2020.
-
Abstract
- Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain. Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0–10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2–C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza® system (Nevro Corp., Redwood City, CA, USA) and included in the safety and effectiveness evaluation at 3 months post-implant (primary endpoint assessment, PEA) and followed to 12 months. Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed. Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.
- Subjects :
- Visual analogue scale
Upper limb pain
Spinal cord stimulation
Upper Extremity
03 medical and health sciences
0302 clinical medicine
medicine
Clinical endpoint
Humans
Pain Management
Orthopedics and Sports Medicine
Prospective Studies
Spinal Cord Stimulation
030222 orthopedics
Neck pain
Neck Pain
business.industry
Australia
Clinical trial
Treatment Outcome
medicine.anatomical_structure
Spinal Cord
Anesthesia
Upper limb
Surgery
Human research
Chronic Pain
medicine.symptom
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 14320932 and 09406719
- Volume :
- 29
- Database :
- OpenAIRE
- Journal :
- European Spine Journal
- Accession number :
- edsair.doi.dedup.....6cc69d4c492814581c7d0c734f01083e