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

April 20, 2017 updated by: Holy Cross Hospital, Florida
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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Pre-implant to 8 weeks post permanent implant
A subject is considered to have met the primary objective if there is a statistically significant (p value < .05) increase in physical function.
Pre-implant to 8 weeks post permanent implant

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: Pre-implant to 8 weeks post permanent implant
Pre-implant to 8 weeks post permanent implant
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).
Time Frame: Pre-implant to 8 weeks post permanent implant
Pre-implant to 8 weeks post permanent implant
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).
Time Frame: Pre-implant to 8 weeks post permanent implant
Pre-implant to 8 weeks post permanent implant
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).
Time Frame: Pre-implant to 8 weeks post permanent implant
Pre-implant to 8 weeks post permanent implant

Other Outcome Measures

Outcome Measure
Time Frame
Evaluate the relationship between physical function and/or pain in subjects stratified into subgroups based on descriptive variables.
Time Frame: Pre-implant to 8 weeks post permanent implant
Pre-implant to 8 weeks post permanent implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holy Cross Hospital, Florida

Investigators

  • Principal Investigator: William P McRoberts, MD, Holy Cross Hospital, FL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

January 27, 2017

Study Completion (Actual)

January 27, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Actigraph IIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Back Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe