The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks,with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of Participants With Reduction in Bladder Medication
Time frame: baseline, 3 months
Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline
The Neurogenic Bladder Symptom (NBSS) Score is a questionnaire that measures bladder symptoms, with total score ranging from 0 to 74; a higher score indicating a worse outcome. Scores at baseline are compared to scores at 3 months, and a change is reported categorically as follows: Stable: A score change within + 5 or -5 points (not including 5) Worse: A score increase of 5 points or more from baseline Improved: A score decrease of 5 points or more from baseline These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change
Time frame: Baseline, 3 months
Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary
Time frame: baseline, 3 months
Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline
The Incontinence Quality of Life questionnaire assesses the impact of urinary incontinence on a person's quality of life. The total score ranges from 0 to 100, a lower score indicating a worse outcome. Scores at baseline are compared to scores at 3 months, and a change is reported as categorically as follows: Stable: A score change within +4 or -4 points (not including 4) Worse: A score decrease of 4 or more points from baseline Improved: A score increase of 4 or more points from baseline These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change.
Time frame: baseline, 3 months
Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey
Time frame: baseline, 3 months
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Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study
Time frame: baseline, 3 months