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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854629
• Other study ID #: Orthosis Spinomed active
• Status: Completed
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: January 2022
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Bone Diseases, Metabolic
• Kyphosis
• Osteopenia

Intervention

Other:
• Spinomed 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

Locations

Country	Name	City	State
Germany	Institute of Medical Physics University of Erlangen-Nurnberg	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	medi GmbH & Co. KG, Bayreuth, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Kyphosis angle	Changes of kyphosis angle as determined by angle measurement	At baseline and after 16 weeks (i.e. over 16 weeks)
Secondary	Functional capacity	Changes in Chair-Rise-Test	At baseline and after 16 weeks (i.e. over 16 weeks)
Secondary	Pulmonary function	Changes in vital capacity as determined by a pulmonary function monitor	At baseline and after 16 weeks (i.e. over 16 weeks)
Secondary	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)
Secondary	Balance capacity	Changes in Body Sway as determined by a balance sensor device	At baseline and after 16 weeks (i.e. over 16 weeks)