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.
Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic SCI. Neuromodulation techniques have also been safely and successfully used to strengthen the abdomen in stroke patients.10 Most similar to our TINS protocol is transcutaneous tibial nerve stimulation (TTNS), which has shown to mitigate the development of neurogenic bladder in acute SCI.6 However, neuromodulation is rarely performed in acute SCI, and, to our knowledge, neuromodulation has not been performed to prevent the development of chronic neuropathic pain. There has been little published regarding the effects of electric stimulation upon the trunk in acute SCI as a prevention for chronic neuropathic pain and spasticity. Gaps in the knowledge which we intend to fill are: 1. Safety and feasibility of TINS in acute SCI during inpatient rehabilitation. 2. Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission, discharge, and weekly numerical pain scores and spasticity questionnaire scores in those with TINS compared to sham TINS for 2-months. 3. Analysis of neuropathic pain medication dosages in those with and without TINS at admission, discharge, and 2 months post-discharge, and evaluation of morbidity at 2- months post-discharge
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of participants with morbidity as measured by infections
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections
Time frame: Admission
Number of participants with morbidity as measured by infections
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.
Time frame: 4-weeks post injury
Number of participants with morbidity as measured by infections
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.
Time frame: 2-month follow-up
Number of participants with morbidity as measured by burns.
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.
Time frame: Admission
Number of participants with morbidity as measured by burns.
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.
Time frame: 4-weeks post injury
Number of participants with morbidity as measured by burns.
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.
Time frame: 2-month follow-up
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
Time frame: Admission
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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
Time frame: 4-weeks post injury
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
Time frame: 2-month follow up
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
Time frame: Admission
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
Time frame: 4-weeks post injury
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
Time frame: 2-month follow-up
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.
Time frame: Baseline
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.
Time frame: 2-month follow-up
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.
Time frame: 4-weeks post injury
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.
Time frame: 2-month follow-up