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| Name | Class |
|---|---|
| University Orthopaedic Associates - Division of OrthoNJ | UNKNOWN |
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The purpose of this study is to track and investigate the outcomes of female patients with acute thoracolumbar compression fractures, focusing on pain management and functional improvement. The study will investigate patients whose compression fractures are within 3 months or less and measure pain scores, using the Numeric Rating Scale (NRS) and Brief Pain Inventory (BPI) and quality of life using the PROMIS questionnaire at 1-week prior to intervention and then 2 weeks, 3 months and 6 months post PNS implantation.
The primary aim is to assess pain reduction among participants that receive the 60-day PNS intervention. The secondary aim is to analyze functional outcomes and quality of life documented in PROMs (Patient Reported Outcomes Measures) provided by CareSense a digital data collection system.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPRINT PNS modulation system | Device | Participants will receive treatment using the commercially available SPRINT PNS system. Their pain levels will be assessed using qualified scales including NRS and BPI and their quality of life using the PROMIS scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Pain as measured using a numeric rating scale (NRS). A 0 - 10 point scale with 0 representing no pain, 1-3 mild, 4-6 moderate and 7-10 severe. | Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation |
| Change in Pain | Pain as measured using a Brief Pain Inventory (BPI). A 0 - 10 point scale with 0 representing no pain and 10 representing severe pain. | Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (QOL) | QOL as measured by PROMIS (Patient-Reported Outcomes Measurement Information System). Responses are scored on 20 to 80 point scale. Scores between 20-55 are within normal limits. Scores 55+ will fall within mild-moderate-severe. | Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatient Orthopedic Clinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Orthopaedic Associates - Division of OrthoNJ | Recruiting | Avenel | New Jersey | 07001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15365697 | Background | Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int. 2005 Mar;16 Suppl 2:S3-7. doi: 10.1007/s00198-004-1702-6. Epub 2004 Sep 8. | |
| 39239614 | Background | Gautam S, Gopal VG, Khuba S, Agarwal A, V M, Kumar S. Evaluation of the role of vertebral augmentation in chronic vertebral compression fractures: A retrospective study. Interv Pain Med. 2023 Mar 11;2(1):100242. doi: 10.1016/j.inpm.2023.100242. eCollection 2023 Mar. |
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| University Orthopaedic Associates - Division of OrthoNJ | Recruiting | Morganville | New Jersey | 07751 | United States |
|
| University Center for Ambulatory Surgery (UCAS) | Recruiting | Somerset | New Jersey | 08873 | United States |
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| University Orthopaedic Associates - Division of OrthoNJ | Recruiting | Somerset | New Jersey | 08873 | United States |
|
| 34745463 | Background | Chitneni A, Berger AA, Orhurhu V, Kaye AD, Hasoon J. Peripheral Nerve Stimulation of the Saphenous and Superior Lateral Genicular Nerves for Chronic Pain After Knee Surgery. Orthop Rev (Pavia). 2021 May 31;13(2):24435. doi: 10.52965/001c.24435. eCollection 2021. |
| 37192232 | Background | Huntoon MA, Slavin KV, Hagedorn JM, Crosby ND, Boggs JW. A Retrospective Review of Real-world Outcomes Following 60-day Peripheral Nerve Stimulation for the Treatment of Chronic Pain. Pain Physician. 2023 May;26(3):273-281. |
| 33446005 | Background | Gabriel RA, Ilfeld BM. Acute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system. Expert Rev Med Devices. 2021 Feb;18(2):145-150. doi: 10.1080/17434440.2021.1877134. Epub 2021 Jan 20. |
| 29618171 | Background | Buchbinder R, Johnston RV, Rischin KJ, Homik J, Jones CA, Golmohammadi K, Kallmes DF. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. 2018 Apr 4;4(4):CD006349. doi: 10.1002/14651858.CD006349.pub3. |
| 12480681 | Background | Bernhard J, Heini PF, Villiger PM. Asymptomatic diffuse pulmonary embolism caused by acrylic cement: an unusual complication of percutaneous vertebroplasty. Ann Rheum Dis. 2003 Jan;62(1):85-6. doi: 10.1136/ard.62.1.85. No abstract available. |
| 30395687 | Background | Prince RL, Lewis JR, Lim WH, Wong G, Wilson KE, Khoo BC, Zhu K, Kiel DP, Schousboe JT. Adding Lateral Spine Imaging for Vertebral Fractures to Densitometric Screening: Improving Ascertainment of Patients at High Risk of Incident Osteoporotic Fractures. J Bone Miner Res. 2019 Feb;34(2):282-289. doi: 10.1002/jbmr.3595. Epub 2018 Nov 5. |
| 24771492 | Background | Wright NC, Looker AC, Saag KG, Curtis JR, Delzell ES, Randall S, Dawson-Hughes B. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res. 2014 Nov;29(11):2520-6. doi: 10.1002/jbmr.2269. |