경피증의 TENS

실험적: 위마비 증상을 동반한 피부경화증 환자

장치: 경피 전기 신경 자극

환자는 4주 치료 기간 동안 하루 2회, 45분 동안 TENS 장치를 사용하게 됩니다.

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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.

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.

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.

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.

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.