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

Study Overview
=================
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.

Official Title
-----------------
Effects of the Spinomed Active Orthosis on Chronic Back Pain in Women With Osteoporotic Vertebral Bone Fracture and Hyperkyphosis.

Conditions
-----------------
Osteopenia, Kyphosis

Intervention / Treatment
-----------------
* Other: Spinomed active


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with two study groups in parallel: (1) Spinomed active orthosis or 16 weeks (2) non spinomed active orthosis control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinomed active orthosis<br>Wearing the orthosis for 16 weeks | Other: Spinomed active<br>* 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<br>|
| No Intervention: Control group<br>No intervention: non spinomed active control | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain | Change in back pain (mean intensity over 4 weeks on the numeric pain scale (NPS) 0-10). | At baseline and after 16 weeks (i.e. over 16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk strength/performance | Changes of maximum dynamic trunk strength (index of trunk extension/flexion/lateral flexion) as determined by a dynamic testing device | At baseline and after 16 weeks (i.e. over 16 weeks) | 
| Kyphosis angle | Changes of kyphosis angle as determined by angle measurement | At baseline and after 16 weeks (i.e. over 16 weeks) | 
| Functional capacity | Changes in Chair-Rise-Test | At baseline and after 16 weeks (i.e. over 16 weeks) | 
| Pulmonary function | Changes in vital capacity as determined by a pulmonary function monitor | At baseline and after 16 weeks (i.e. over 16 weeks) | 
| Everyday life skills | Changes of everyday life skills as determined by a questionnaire (late-life function and disability instrument) | At baseline and after 16 weeks (i.e. over 16 weeks) | 
| Balance capacity | Changes in Body Sway as determined by a balance sensor device | At baseline and after 16 weeks (i.e. over 16 weeks) |