Clinical trial NCT02948049: Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)
Official title: Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pain
Back Pain
Neck Pain
Keywords: Accelerometer
Spinal Cord Stimulator
Peripheral Nerve Stimulator
Physical Function
Lead sponsor: Holy Cross Hospital, Florida
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects recruited for this study will be representative of the population of subjects with chronic pain and a candidate for SCS or PNS trial. Subjects recruited for this study must be 18 years of age or older. It is anticipated that approximately equal numbers of males and females will be recruited. No subjects will be excluded based upon his/her race or ethnicity.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess whether there is an increase in objective measurements of physical function in subjects after treatment with an FDA-approved spinal cord stimulation device (SCS) or FDA-approved peripheral nerve stimulation (PNS) device compared with pre-implant.
timeFrame: Pre-implant to 8 weeks post permanent implant
Secondary outcomes:
measure: Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-worn accelerometer in subjects correlate with an improvement in subjective assessments as measured by the Numeric Rating Scale (NRS).
timeFrame: Pre-implant to 8 weeks post permanent implant
measure: Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-worn accelerometer in subjects correlate with an improvement in subjective assessments as measured by the Short Form-36 Health Survey (SF-36).
timeFrame: Pre-implant to 8 weeks post permanent implant
measure: Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-worn accelerometer in subjects correlate with an improvement in subjective assessments as measured by the Oswestry Disability Index (ODI).
timeFrame: Pre-implant to 8 weeks post permanent implant
measure: Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-worn accelerometer in subjects correlate with an improvement in subjective assessments as measured by the Neck Disability Index (NDI).
timeFrame: Pre-implant to 8 weeks post permanent implant
Other outcomes:
measure: Evaluate the relationship between physical function and/or pain in subjects stratified into subgroups based on descriptive variables.
timeFrame: Pre-implant to 8 weeks post permanent implant
Locations:
Study officials:
affiliation: Holy Cross Hospital, FL
name: William P McRoberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
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