Status:
COMPLETED
Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Vertebral Fractures.
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborating Sponsors:
medi GmbH & Co. KG, Bayreuth, Germany
Conditions:
Osteopenia
Kyphosis
Eligibility:
FEMALE
65+ years
Phase:
NA
Brief 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 posit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04854629
Start Date
April 7 2021
End Date
January 15 2022
Last Update
January 19 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Medical Physics University of Erlangen-Nurnberg
Erlangen, Germany, 91052