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

NCT04854629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-01-19

No results posted yet for this study

Summary

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.

Conditions

  • Osteopenia
  • Kyphosis

Interventions

OTHER

Spinomed active

Wearing of the orthosis 2-3 h/twice a day for 16 weeks Supplementation of a maximum of 1000 mg/d calcium and 800 IE/d vitamin D

Sponsors & Collaborators

  • medi GmbH & Co. KG, Bayreuth, Germany

    collaborator UNKNOWN

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Wolfgang Kemmler, PhD · Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2021-12-15
Completion
2022-01-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854629 on ClinicalTrials.gov