WFRF:(Cook Andrew)
Sökning: WFRF:(Cook Andrew) > Multicentre, double...
- 46 av 133
- Föregående post
- Nästa post
- Till träfflistan
Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP) : a trial protocol
-
- Al-Kaisy, Adnan (författare)
- St Thomas Hosp, Pain Management & Neuromodulat Ctr, Westminster Bridge Rd, London SE1 7EH, England
-
- Royds, Jonathan (författare)
- Guys & St Thomas NHS Fdn Trust, London, England
-
- Palmisani, Stefano (författare)
- Guys & St Thomas NHS Fdn Trust, London, England
- visa fler...
- visa färre...
- (creator_code:org_t)
- 2020-01-28
- 2020
- Engelska.
- Ingår i: Trials. - : BMC. - 1745-6215. ; 21
- Tidskriftsartikel (refereegranskat)
Abstract
Ämnesord
Stäng
- Introduction: Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population.Methods: This is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient.Discussion: The outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Annan hälsovetenskap (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Other Health Sciences (hsv//eng)
Nyckelord
- Spinal cord stimulation
- Neuropathic pain
- Chronic neuropathic low back pain
- Neuromodulation
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
- 46 av 133
- Föregående post
- Nästa post
- Till träfflistan
Hitta mer i SwePub
- Av författaren/redakt...
- Al-Kaisy, Adnan
- Royds, Jonathan
- Palmisani, Stefa ...
- Pang, David
- Wesley, Samuel
- Taylor, Rod S.
- visa fler...
- Cook, Andrew
- Eldabe, Sam
- McCracken, Lance ...
- Duarte, Rui
- Fairbank, Jeremy
- visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
- MEDICIN OCH HÄLS ...
- och Hälsovetenskap
- och Annan hälsoveten ...
- Artiklar i publikationen
- Trials
- Av lärosätet
- Uppsala universitet
Sök utanför SwePub
- Sök vidare i:
- Google Book Search
- Google Scholar
Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.
- Copyright © LIBRIS - Nationella bibliotekssystem
- LIBRIS.kb.se
