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NCT04854629

Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Vertebral Fractures.

Completed NA Last updated 19 January 2022
What this trial tests

NA trial testing Spinomed active in Osteopenia in 80 participants. Completed in 15 January 2022.

Timeline
7 April 2021
Primary endpoint
15 December 2021
15 January 2022

Quick facts

Lead sponsorUniversity of Erlangen-Nürnberg Medical School
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment80
Start date7 April 2021
Primary completion15 December 2021
Estimated completion15 January 2022
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Osteopenia

Currently open trials in the same condition.

Other University of Erlangen-Nürnberg Medical School trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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