TENS in Scleroderma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Electrical Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Scleroderma, Gastroparesis, Systemic Sclerosis (SSc). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcutaneous Electrical Nerve Stimulation in Scleroderma
Overview
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.
Interventions
- Device Transcutaneous Electrical Nerve Stimulation
Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
Primary outcome measures
- Tolerability of the TENS device [Time frame: 14 months]
Secondary outcome measures (3)
- Efficacy of TENS in treating Scleroderma-related Gastroparesis [Time frame: 14 months]
- Assessment of the Effect of TENS of Gastroparesis Symptoms [Time frame: 14 months]
- Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis [Time frame: 14 months]
Eligibility criteria
Inclusion criteria
- 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
- Stable GI specific therapy including prokinetics over the last 4 weeks.
Exclusion criteria
- 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.
- Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Publications
- Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25. PMID 19558608
- Khanna D, Hays RD, Maranian P, Seibold JR, Impens A, Mayes MD, Clements PJ, Getzug T, Fathi N, Bechtel A, Furst DE. Reliability and validity of the University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. Arthritis Rheum. 2009 Sep 15;61(9):1257-63. doi: 10.1002/art.24730. PMID 19714600
- McMahan ZH, Kulkarni S, Chen J, Chen JZ, Xavier RJ, Pasricha PJ, Khanna D. Systemic sclerosis gastrointestinal dysmotility: risk factors, pathophysiology, diagnosis and management. Nat Rev Rheumatol. 2023 Mar;19(3):166-181. doi: 10.1038/s41584-022-00900-6. Epub 2023 Feb 6. PMID 36747090
- Song G, Trujillo S, Fu Y, Shibi F, Chen J, Fass R. Transcutaneous electrical stimulation for gastrointestinal motility disorders. Neurogastroenterol Motil. 2023 Nov;35(11):e14618. doi: 10.1111/nmo.14618. Epub 2023 Jun 8. PMID 37288650
Identifiers
NCT: NCT06646913 · HUM00246152