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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia; Kyphosis
• Intervention / Treatment: Other: Spinomed active

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Institute of Medical Physics University of Erlangen-Nurnberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinomed active orthosis; Wearing the orthosis for 16 weeks	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
No Intervention: Control group; 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)

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: medi GmbH & Co. KG, Bayreuth, Germany
• Investigators: Study Chair: Wolfgang Kemmler, PhD, Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Back Pain; Bone Diseases, Metabolic; Kyphosis
• Other Study ID Numbers: Orthosis Spinomed active

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data that support the findings of this study are available on request from the corresponding researcher (SW)
• IPD Sharing Time Frame: Data will become available in March 2022 without time limit.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No