NCT02948049

Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Holy Cross Hospital, Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a single site, prospective, observational trial utilizing a wrist-worn accelerometer to evaluate clinical outcomes of SCS and PNS in the treatment of chronic pain.

Detailed description

Up to 150 evaluable subjects will be recruited at this site on an ongoing basis. Evaluable subjects are defined as subjects that complete the End of Study visit. Each subject will be assigned an accelerometer and have data recorded for a seven-day period pre-implant trial to collect baseline data. The accelerometer will also be worn during the trial for a period of up to seven (7) days. If the trial is successful and the subject is implanted, the subject will wear the accelerometer for a seven-day period at least six (6) weeks post-permanent implant. The following assessments will be administered to subjects at the baseline (pre-implant trial) visit, the end of implant trial visit and the end of study visit (8 weeks post-permanent implant): the Numerical Rating Scale (NRS) 11-point scale for pain; the SF-36 Health Survey; the Oswestry Disability Index (ODI). Subjects treated for neck pain will also complete the Neck Disability Index (NDI). Additionally, the subjects will be asked to complete a subject diary to record average daily NRS scores for days the accelerometer is worn.

Conditions

• Chronic Pain
• Back Pain
• Neck Pain

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-01-27
• Completion: 2017-01-27
• First posted: 2016-10-28
• Last updated: 2017-04-21