CA2017 NSRBP study Rev A
Research type
Research Study
Full title
A Multi-Center, Prospective, Pragmatic, Randomized, Controlled Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-Surgical Refractory Back Pain
IRAS ID
224762
Contact name
Wim Laloo
Contact email
Sponsor organisation
Nevro Corp
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
Subjects who sign the informed consent will be evaluated for eligibility, based on the study inclusion and exclusion criteria. They then will be randomised to one of the two groups to receive HF10 stimulation in addition to conventional medical management (CMM) or to the CMM only group. HF10 therapy is being used as per its approved labelling. Implantation and use of the HF10 will follow the Nevro Physician's Manual, supporting Manuals and centres’ routine practice. All attempts will be made to optimize therapy based on the Investigators evaluation.
Subjects randomized to the stimulation group will have a trial stimulation phase, and post-trial assessment. Those subjects with a successful Trial Phase will receive a permanent implant of an implantable pulse generator (IPG) and leads, and undergo 12 months of stimulation delivery with follow up and assessments at 1, 3, 6, 9 and 12 months after permanent device activation – in addition to their conventional medical management. The time between implant and activation will be up to 2 weeks providing time for surgical wounds to heal and for the implant medication to washout.
Subjects randomized to the conventional medical management group will receive the normal standard of care at that site. Subjects will be assessed at 1, 3, 6, 9 and 12 months post-randomization with the option of crossing over to the stimulation group at 6 months, if satisfactory pain relief is not achieved. This decision will be based on the investigator's clinical judgement and subject's decision
At all time- points following activation, assessments and monitoring of pain and adverse events will be made.
Subjects will be assessed for pain, disability, sleep disturbance, quality of life, mental and physical function, patient and clinician global impression of change, subject satisfaction, neurological assessment, work status, medication use, adverse events and healthcare utilisation.REC name
North East - York Research Ethics Committee
REC reference
17/NE/0240
Date of REC Opinion
8 Aug 2017
REC opinion
Further Information Favourable Opinion