Neuropathic Pain, SCI - Spinal Cord Injury
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICETINS Active protocol
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.
DEVICESham protocol
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Study participants will be blinded to the stimulation parameters of the TINS. The research assistant/investigator will apply the electrodes and the PI will be blinded the stimulation setting as well. Unblinding is expected to occur after the 2 month follow up, at which point both subject and PI will be made aware of their group assignment.
Intervention model description
Randomized sham-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with morbidity as measured by infections | Admission | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections |
| Number of participants with morbidity as measured by burns. | Admission | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns. |
| Number of participants with morbidity as measured by urgent transfers. | Admission | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers |
| Number of participants with morbidity as measured by spasticity scores per usual care. | Admission | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS) | Baseline | 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. |
| Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up. | 4-weeks post injury | Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up. |
Countries
United States
Outcome results
None listed