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.

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

Higher incidence of osteopenia in female population

The data that support the findings of this study are available on request from the corresponding researcher (SW)

Data will become available in March 2022 without time limit.

Outcomes assessor were unaware of participant status (i.e. spinomed active or control) and were not allowed to ask correspondingly