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

Holy Cross Hospital, Florida

Status: Terminated

Conditions: Back Pain; Chronic Pain; Neck Pain

Study type: Observational

Funder types: Other

Identifiers

NCT02948049

Actigraph IIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects enrolled in this study must meet the following criteria:

1. Subject is 18 years of age or older
2. Subject is a candidate for on label use of a SCS or PNS device
3. Subject is ambulatory
4. Subject is able to understand and willing to comply with study procedures and requirements
5. Subject is able to provide informed consent to participate in the study

Exclusion criteria

Subjects will be excluded from participation in this study if they meet any one of the following criteria:

1. Subject has comorbidities that, in the judgment of the investigator, may confound the reliability of the information acquired in this study
2. In the judgment of the investigator, the subject is not seeking an improvement in physical function as a treatment goal of SCS or PNS