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

NCT02948049 | Terminated

• 1 other identifier: Actigraph IIT
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain; Back Pain; Neck Pain

Keywords

Accelerometer; Spinal Cord Stimulator; Peripheral Nerve Stimulator; Physical Function

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (4)

• 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).

  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).

  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).

  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).

  Pre-implant to 8 weeks post permanent implant

Other Outcomes (1)

• Evaluate the relationship between physical function and/or pain in subjects stratified into subgroups based on descriptive variables.

  Pre-implant to 8 weeks post permanent implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects enrolled in this study must meet the following criteria:
• Subject is 18 years of age or older
• Subject is a candidate for on label use of a SCS or PNS device
• Subject is ambulatory
• Subject is able to understand and willing to comply with study procedures and requirements
• Subject is able to provide informed consent to participate in the study

You may not qualify if:

• Subjects will be excluded from participation in this study if they meet any one of the following criteria:
• Subject has comorbidities that, in the judgment of the investigator, may confound the reliability of the information acquired in this study
• In the judgment of the investigator, the subject is not seeking an improvement in physical function as a treatment goal of SCS or PNS

Sponsors & Collaborators

• Holy Cross Hospital, Florida: lead

Related Publications (11)

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967 Jul-Aug;46(4):489-91. No abstract available.

  PMID: 4952225 BACKGROUND

• Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008 Oct;63(4):762-70; discussion 770. doi: 10.1227/01.NEU.0000325731.46702.D9.

  PMID: 18981888 BACKGROUND

• Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.

  PMID: 18487245 BACKGROUND

• Perruchoud C, Buchser E, Johanek LM, Aminian K, Paraschiv-Ionescu A, Taylor RS. Assessment of physical activity of patients with chronic pain. Neuromodulation. 2014 Jun;17 Suppl 1:42-7. doi: 10.1111/ner.12036.

  PMID: 24974774 BACKGROUND

• Paraschiv-Ionescu A, Perruchoud C, Buchser E, Aminian K. Barcoding human physical activity to assess chronic pain conditions. PLoS One. 2012;7(2):e32239. doi: 10.1371/journal.pone.0032239. Epub 2012 Feb 23.

  PMID: 22384191 BACKGROUND

• Huang KT, Martin J, Marky A, Chagoya G, Hatef J, Hazzard MA, Thomas SM, Lokhnygina Y, Lad SP. A national survey of spinal cord stimulation trial-to-permanent conversion rates. Neuromodulation. 2015 Feb;18(2):133-9; discussion 139-40. doi: 10.1111/ner.12199. Epub 2014 Jun 13.

  PMID: 24930992 BACKGROUND

• Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

  PMID: 15621359 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

  PMID: 11074683 BACKGROUND

• Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

  PMID: 1834753 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William P McRoberts, MD

  Holy Cross Hospital, FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 28, 2016
• Study Start: October 1, 2016
• Primary Completion: January 27, 2017
• Study Completion: January 27, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share