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NCT04854629
Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Vertebral Fractures.
NA trial testing Spinomed active in Osteopenia in 80 participants. Completed in 15 January 2022.
15 December 2021
Quick facts
| Lead sponsor | University of Erlangen-Nürnberg Medical School |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 80 |
| Start date | 7 April 2021 |
| Primary completion | 15 December 2021 |
| Estimated completion | 15 January 2022 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Spinomed active
Conditions studied
- Osteopenia — all drugs for Osteopenia →
- Kyphosis — all drugs for Kyphosis →
Sponsor
University of Erlangen-Nürnberg Medical School
Who can join
65 and older, female only, with Osteopenia or Kyphosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Osteoporotic vertebral fractures often lead to postural changes, chronic spinal pain conditions and limited functionality. Orthoses that straighten the spine have been shown in studies to have a positive effect on pain, posture and the functional state of patients with a fresh vertebral fracture. The planned study investigates the effect of the orthosis "Spinomed active" in patients aged ≥ 65 years with at least one non-acute osteoporotic vertebral fracture (at least 3 months ago) and chronic back pain.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effects of the "Spinomed active" orthosis on chronic back pain in kyphotic women with osteoporotic vertebral fractures three months and older: A randomized controlled study.
Hettchen M, Willert S, von Stengel S, Kohl M, et al · · 2022 · cited 3× · PMID 36618579 · DOI 10.3389/fpain.2022.1038269 -
Effects of Active Spinal Orthosis on Fatty Infiltration in Paraspinal Muscles in Kyphotic Women with Osteoporotic Vertebral Fracture-Sub-Analysis of a Randomized Controlled Trial.
Hiller M, Kohl M, Chaudry O, Engelke K, et al · · 2025 · PMID 40508875 · DOI 10.3390/healthcare13111262
Verify or expand the search:
- PubMed search for NCT04854629
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Erlangen-Nürnberg Medical School trials
Trials by the same sponsor.
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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 NCT04854629 (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 University of Erlangen-Nürnberg Medical School
- Last refreshed: 19 January 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/NCT04854629.
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