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

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Osteopenia; Kyphosis

Treatments: Other: Spinomed active

Study type: Interventional

Funder types: Other

Identifiers

NCT04854629

Orthosis Spinomed active

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Spinomed active orthosis

Experimental group

Description:

Wearing the orthosis for 16 weeks

Treatment:

Other: Spinomed active

Control group

No Intervention group

Description:

No intervention: non spinomed active control