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

University of Erlangen-Nürnberg Medical School80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Osteopenia Kyphosis

Interventions

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Living independently in the community * ≥ 1 low-traumatic vertebral fracture ≥ 3 months ago * Chronic back pain according to the national guideline for low back pain * Mean back pain intensity NPS ≥ 1 (1-10 scale) * Hyperkyphosis, kyphosis angle according to Debrunner \>40° * Intact skin or adequate wound coverage in the area of the contact surface of the orthosis Exclusion Criteria: * Secondary osteoporosis (as determined by study physician) * Expected change in overall pain therapy during the study period * Structurally fixed kyphosis, lack of extension ability of the thoracic spine * Kyphoplasty, vertebroplasty * Use of back orthoses during the last 6 months * Depression * Dementia, cognitive impairment (Mini Mental Test \< 25) * Fresh neurological deficits; incontinence \> grade 1 * Body dimensions that do not allow for adjustment of the back orthosis * Absence during baseline and follow-up assessments