Kyphosis, Osteopenia
Conditions
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 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.
Interventions
OTHERSpinomed 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
medi GmbH & Co. KG, Bayreuth, Germany
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor were unaware of participant status (i.e. spinomed active or control) and were not allowed to ask correspondingly
Intervention model description
Randomized controlled trial with two study groups in parallel: (1) Spinomed active orthosis or 16 weeks (2) non spinomed active orthosis control
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Back pain | At baseline and after 16 weeks (i.e. over 16 weeks) | Change in back pain (mean intensity over 4 weeks on the numeric pain scale (NPS) 0-10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kyphosis angle | At baseline and after 16 weeks (i.e. over 16 weeks) | Changes of kyphosis angle as determined by angle measurement |
| Functional capacity | At baseline and after 16 weeks (i.e. over 16 weeks) | Changes in Chair-Rise-Test |
| Trunk strength/performance | At baseline and after 16 weeks (i.e. over 16 weeks) | Changes of maximum dynamic trunk strength (index of trunk extension/flexion/lateral flexion) as determined by a dynamic testing device |
| Everyday life skills | At baseline and after 16 weeks (i.e. over 16 weeks) | Changes of everyday life skills as determined by a questionnaire (late-life function and disability instrument) |
| Balance capacity | At baseline and after 16 weeks (i.e. over 16 weeks) | Changes in Body Sway as determined by a balance sensor device |
| Pulmonary function | At baseline and after 16 weeks (i.e. over 16 weeks) | Changes in vital capacity as determined by a pulmonary function monitor |
Countries
Germany
Outcome results
None listed