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Accelerometer Study

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

This study is enrolling participants by invitation only.

Sponsor:

Holy Cross Hospital, Florida

Information provided by (Responsible Party):

Holy Cross Hospital, Florida

ClinicalTrials.gov Identifier: NCT02948049

Purpose

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.

 

Condition
Chronic Pain
Back Pain
Neck Pain

 

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)

 

Further study details as provided by Holy Cross Hospital, Florida:

Primary Outcome Measures:

  • 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 ] [ Designated as safety issue: No ]

A subject is considered to have met the primary objective if there is a statistically significant (p value < .05) increase in physical function.

 

Secondary Outcome Measures:

  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer 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 ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer 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 ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer 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 ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer 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 ] [ Designated as safety issue: No ]

 

Other Outcome Measures:

  • 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 ] [ Designated as safety issue: No ]

 

Estimated Enrollment: 150
Study Start Date: October 2016
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study: 18 Years and older   (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
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.

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

Accelerometer Studytriangle  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02948049

Sponsors and Collaborators
Holy Cross Hospital, Florida
Investigators
Principal Investigator: William P McRoberts, MD Holy Cross Hospital, FL
Accelerometer Studytriangle  More Information
Additional Information:
Publications:
  1. Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. Review.
  2. 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.
  3. 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.
  4. 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. Review.
  5. 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. Review.
  6. 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.
  7. 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.
  8. 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. Review.
  9. 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.
  10. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review.
  11. Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum in: J Manipulative Physiol Ther 1992 Jan;15(1):followi.
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4 Comments

  • electricscootershq.org

    Examples of cohort studies of cardiometabolic diseases and cancer using accelerometers to assess physical activity and sedentary behaviour

    • admin

      Thank you

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