Clinical trial NCT04854629: Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Vertebral Fractures.
Official title: Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Osteoporotic Vertebral Bone Fracture and Hyperkyphosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Kyphosis
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: medi GmbH & Co. KG, Bayreuth, Germany
First posted: 2021-04-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Back pain
timeFrame: At baseline and after 16 weeks (i.e. over 16 weeks)
Secondary outcomes:
measure: Trunk strength/performance
timeFrame: At baseline and after 16 weeks (i.e. over 16 weeks)
measure: Kyphosis angle
timeFrame: At baseline and after 16 weeks (i.e. over 16 weeks)
measure: Functional capacity
timeFrame: At baseline and after 16 weeks (i.e. over 16 weeks)
measure: Pulmonary function
timeFrame: At baseline and after 16 weeks (i.e. over 16 weeks)
measure: Everyday life skills
timeFrame: At baseline and after 16 weeks (i.e. over 16 weeks)
measure: Balance capacity
timeFrame: At baseline and after 16 weeks (i.e. over 16 weeks)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics University of Erlangen-Nurnberg
Study officials:
affiliation: Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg
name: Wolfgang Kemmler, PhD
role: STUDY_CHAIR
References: