TENS in Scleroderma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.
Age >= 18 years
English speaking.
Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
Disqualifiers
Pregnancy, or currently lactating.
A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
Known allergy to adhesive ECG electrodes.
Trial design
Design model
Single group
Treatments tested in this trial
Transcutaneous Electrical Nerve Stimulation
DevicePatients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Scleroderma Patients with Gastroparesis SymptomsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tolerability of the TENS device
1. Proportion of subjects who are able to complete the trial 2. Proportion of subjects who utilize the device for at least 80% of the proposed applications.
Time frame
14 monthsSecondary outcomes
1
Efficacy of TENS in treating Scleroderma-related Gastroparesis
To assess the mean change in the GCSI Total score (0-4 where higher score reflects greater severity) after the TENS intervention.
Time frame
14 months2
Assessment of the Effect of TENS of Gastroparesis Symptoms
To assess the mean change in the GIT 2.0 Distention/Bloating scale (0-3.0 where 0 is lower severity and 3.0 is greater severity) after the TENS intervention.
Time frame
14 months3
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
To evaluate the number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
14 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov