Neuropathic Pain Clinical Trial
— TINSOfficial title:
Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
Verified date | October 2021 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Acute tSCI paraplegia within 4 weeks of injury (n=22) - 18-75 years old - Neurologic levels T1-T10 - English speaking - Admitted to TIRR with pain medications - TINS can elicit visible or palpable abdominal muscle contraction Exclusion Criteria: - Subjects with pacemakers, defibrillators, insulin pumps, and similar devices - History of peripheral neuropathy - History of premorbid symptoms of peripheral neuropathy (numbness and/or tingling in the lower extremities, sharp/jabbing/burning pain in the lower extremities, sensitivity to touch, lack of coordination, lack of sensation, muscle weakness, etc.) - History of nervous system disorder (i.e. prior SCI, stroke, brain injury, degenerative diseases such as Parkinson's disease, etc.) - Ventilator dependent respiration - Inability to speak - Non-English speakers - Pregnancy - History of chronic pain - Intolerant to electric stimulation - Intolerant to the trial sessions |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. Review. — View Citation
Ataoglu E, Tiftik T, Kara M, Tunç H, Ersöz M, Akkus S. Effects of chronic pain on quality of life and depression in patients with spinal cord injury. Spinal Cord. 2013 Jan;51(1):23-6. doi: 10.1038/sc.2012.51. Epub 2012 May 1. — View Citation
Bellucci CH, Wöllner J, Gregorini F, Birnböck D, Kozomara M, Mehnert U, Schubert M, Kessler TM. Acute spinal cord injury--do ambulatory patients need urodynamic investigations? J Urol. 2013 Apr;189(4):1369-73. doi: 10.1016/j.juro.2012.10.013. Epub 2012 Oct 12. — View Citation
Büchele G, Och B, Bolte G, Weiland SK. Single vs. double data entry. Epidemiology. 2005 Jan;16(1):130-1. — View Citation
Chartier-Kastler EJ, Denys P, Chancellor MB, Haertig A, Bussel B, Richard F. Urodynamic monitoring during percutaneous sacral nerve neurostimulation in patients with neurogenic detrusor hyperreflexia. Neurourol Urodyn. 2001;20(1):61-71. — View Citation
Diamond J, Foerster A. Recovery of sensory function in skin deprived of its innervation by lesion of the peripheral nerve. Exp Neurol. 1992 Jan;115(1):100-3. Review. — View Citation
Dubeau CE. The aging lower urinary tract. J Urol. 2006 Mar;175(3 Pt 2):S11-5. Review. — View Citation
Gwak YS, Hulsebosch CE. Neuronal hyperexcitability: a substrate for central neuropathic pain after spinal cord injury. Curr Pain Headache Rep. 2011 Jun;15(3):215-22. doi: 10.1007/s11916-011-0186-2. Review. — View Citation
Hatch MN, Cushing TR, Carlson GD, Chang EY. Neuropathic pain and SCI: Identification and treatment strategies in the 21st century. J Neurol Sci. 2018 Jan 15;384:75-83. doi: 10.1016/j.jns.2017.11.018. Epub 2017 Nov 16. Review. — View Citation
http://www.emsci.org/index.php/project/the-project/time-schedule
https://www.nscisc.uab.edu/Public/Facts%202015.pdf
Johnson MI, Bjordal JM. Transcutaneous electrical nerve stimulation for the management of painful conditions: focus on neuropathic pain. Expert Rev Neurother. 2011 May;11(5):735-53. doi: 10.1586/ern.11.48. Review. — View Citation
Ko EJ, Chun MH, Kim DY, Yi JH, Kim W, Hong J. The Additive Effects of Core Muscle Strengthening and Trunk NMES on Trunk Balance in Stroke Patients. Ann Rehabil Med. 2016 Feb;40(1):142-51. doi: 10.5535/arm.2016.40.1.142. Epub 2016 Feb 26. — View Citation
McNeill DL, Carlton SM, Hulsebosch CE. Intraspinal sprouting of calcitonin gene-related peptide containing primary afferents after deafferentation in the rat. Exp Neurol. 1991 Dec;114(3):321-9. — View Citation
McNeill DL, Hulsebosch CE. Intraspinal sprouting of rat primary afferents after deafferentation. Neurosci Lett. 1987 Oct 16;81(1-2):57-62. — View Citation
Nichols ME, Meador KJ, Loring DW, Poon LW, Clayton GM, Martin P. Age-related changes in the neurologic examination of healthy sexagenarians, octogenarians, and centenarians. J Geriatr Psychiatry Neurol. 1994 Jan-Mar;7(1):1-7. — View Citation
Petersen EA, Slavin KV. Peripheral nerve/field stimulation for chronic pain. Neurosurg Clin N Am. 2014 Oct;25(4):789-97. doi: 10.1016/j.nec.2014.07.003. Epub 2014 Aug 15. Review. — View Citation
Stampas A, Korupolu R, Zhu L, Smith CP, Gustafson K. Safety, Feasibility, and Efficacy of Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury Neurogenic Bladder: A Randomized Control Pilot Trial. Neuromodulation. 2019 Aug;22(6):716-722. doi: 10.1111/ner.12855. Epub 2018 Oct 3. — View Citation
Verrills P, Vivian D, Mitchell B, Barnard A. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med. 2011 Sep;12(9):1395-405. doi: 10.1111/j.1526-4637.2011.01201.x. Epub 2011 Aug 3. Review. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with morbidity as measured by infections | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections | Admission | |
Primary | Number of participants with morbidity as measured by infections | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections. | 4-weeks post injury | |
Primary | Number of participants with morbidity as measured by infections | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections. | 2-month follow-up | |
Primary | Number of participants with morbidity as measured by burns. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns. | Admission | |
Primary | Number of participants with morbidity as measured by burns. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns. | 4-weeks post injury | |
Primary | Number of participants with morbidity as measured by burns. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns. | 2-month follow-up | |
Primary | Number of participants with morbidity as measured by urgent transfers. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers | Admission | |
Primary | Number of participants with morbidity as measured by urgent transfers. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers | 4-weeks post injury | |
Primary | Number of participants with morbidity as measured by urgent transfers. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers | 2-month follow up | |
Primary | Number of participants with morbidity as measured by spasticity scores per usual care. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care | Admission | |
Primary | Number of participants with morbidity as measured by spasticity scores per usual care. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care | 4-weeks post injury | |
Primary | Number of participants with morbidity as measured by spasticity scores per usual care. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care | 2-month follow-up | |
Secondary | Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS) | Contains clinically relevant core questions concerning SCI-related pain. This is a 2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity. Developed to augment clinical ratings of spasticity and provide a more comprehensive understanding of an individual's spasticity status. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe". The second component is not answered if the person indicates they have no spasms in part. Lower scores indicate better outcomes. | Baseline | |
Secondary | Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS) | Contains clinically relevant core questions concerning SCI-related pain. This is a 2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity. Developed to augment clinical ratings of spasticity and provide a more comprehensive understanding of an individual's spasticity status. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe". The second component is not answered if the person indicates they have no spasms in part. Lower scores indicate better outcomes. | 2-month follow-up | |
Secondary | Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up. | Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up. | 4-weeks post injury | |
Secondary | Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up. | Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up. | 2-month follow-up |
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