The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is: To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma. Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
University of Michigan
Ann Arbor, Michigan, United States
Acceptability of the TENS Device
Acceptability of the TENS device as demonstrated by: 1. Subjects who are able to complete the trial by reaching the end of the testing period with the device 2. Subjects who utilize the device for at least 80% of the proposed applications.
Time frame: 4 weeks
Efficacy of TENS in Treating Scleroderma-related Gastroparesis
Mean change in the GCSI Total score (0-4 where higher score reflects greater severity)from baseline to after the TENS intervention.
Time frame: 4 weeks
Assessment of the Effect of TENS of Gastroparesis Symptoms
Mean change in the ULCA-GIT 2.0 Distention/Bloating scale (0-3.0 where 0 is lowest severity and 3.0 is greatest severity) from baseline to after the TENS intervention.
Time frame: 4 weeks
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. The CTCAE v5.0 is a standardize tool to grade adverse events on a scale of 1 to 5, where 1 is "mild" grade 2 is "moderate", 3 is "severe", 4 is "life threatening", and 5 is "death". Outcome is shown as number of participants who experienced an adverse event in each possible grade.
Time frame: 8 weeks
Gastric Motility in Participants
Participants were categorized as having "normal" or "abnormal" gastric motility at baseline. Those who were categorized as "abnormal" at baseline repeated the test at 4 weeks, after the intervention. Those who were classified as "normal" did not repeat the test.
Time frame: 4 weeks
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