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NCT03978585: HIT-CIPN
Comparison of High Tone Therapy and TENS Therapy
NA trial testing high tone external muscle stimulation in Peripheral Nervous System Problem in 51 participants. Completed in 31 December 2021.
31 December 2021
Quick facts
| Lead sponsor | Paracelsus Medical University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 3 September 2019 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- high tone external muscle stimulation
- transcutaneous electrical nerve stimulation (TENS) therapy
Conditions studied
- Peripheral Nervous System Problem — all drugs for Peripheral Nervous System Problem →
Sponsor
Paracelsus Medical University
Who can join
18 and older, any sex, with Peripheral Nervous System Problem. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the efficacy of home-based high tone external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation (TENS) in chemotherapy-induced peripheral neuropathy (CIPN). One half of the participants will receive TENS therapy, the other half will receive High tone external muscle Stimulation. It is expected that HTEMS improves symptoms of CIPN.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Electrotherapy as treatment for chemotherapy-induced peripheral neuropathy - a randomized controlled trial.
Sassmann R, Gampenrieder SP, Rieder F, Johansson T, et al · · 2024 · cited 3× · PMID 39777312 · DOI 10.3389/fneur.2024.1451456 -
Different types of electrostimulation target specific impaired sensory and motor functions in chemotherapy-induced peripheral neuropathy: a secondary analysis of a controlled trial.
Rieder F, Sassmann R, Kienberger YT, Castagnaviz V, et al · · 2026 · PMID 41859404 · DOI 10.3389/fneur.2026.1653161
Verify or expand the search:
- PubMed search for NCT03978585
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of high tone external muscle stimulation
Trials testing the same drug.
- NCT06664723 — High Tone External Muscle Stimulation on Diabetic Foot Ulcer · NA · not yet recruiting
Other Paracelsus Medical University trials
Trials by the same sponsor.
- NCT07315334 — Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy · not yet recruiting
- NCT04591860 — A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutur · NA · not yet recruiting
- NCT06056193 — The SIR-POBA Bypass Trial · NA · withdrawn
- NCT06056206 — The SIR-POBA Shunt Trial · NA · withdrawn
- NCT05506111 — Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma. · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03978585 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Paracelsus Medical University
- Last refreshed: 28 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03978585.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing