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

Primary Purpose

Osteopenia, Kyphosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Spinomed active
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteopenia

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Medical Physics University of Erlangen-Nurnberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Spinomed active orthosis

Control group

Arm Description

Wearing the orthosis for 16 weeks

No intervention: non spinomed active control

Outcomes

Primary Outcome Measures

Back pain
Change in back pain (mean intensity over 4 weeks on the "numeric pain scale (NPS) "0-10").

Secondary Outcome Measures

Trunk strength/performance
Changes of maximum dynamic trunk strength (index of trunk extension/flexion/lateral flexion) as determined by a dynamic testing device
Kyphosis angle
Changes of kyphosis angle as determined by angle measurement
Functional capacity
Changes in Chair-Rise-Test
Pulmonary function
Changes in vital capacity as determined by a pulmonary function monitor
Everyday life skills
Changes of everyday life skills as determined by a questionnaire (late-life function and disability instrument)
Balance capacity
Changes in Body Sway as determined by a balance sensor device

Full Information

First Posted
April 13, 2021
Last Updated
January 18, 2022
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
medi GmbH & Co. KG, Bayreuth, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04854629
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
medi GmbH & Co. KG, Bayreuth, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Kyphosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcomes assessor were unaware of participant status (i.e. spinomed active or control) and were not allowed to ask correspondingly
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinomed active orthosis
Arm Type
Experimental
Arm Description
Wearing the orthosis for 16 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention: non spinomed active control
Intervention Type
Other
Intervention Name(s)
Spinomed active
Intervention Description
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
Primary Outcome Measure Information:
Title
Back pain
Description
Change in back pain (mean intensity over 4 weeks on the "numeric pain scale (NPS) "0-10").
Time Frame
At baseline and after 16 weeks (i.e. over 16 weeks)
Secondary Outcome Measure Information:
Title
Trunk strength/performance
Description
Changes of maximum dynamic trunk strength (index of trunk extension/flexion/lateral flexion) as determined by a dynamic testing device
Time Frame
At baseline and after 16 weeks (i.e. over 16 weeks)
Title
Kyphosis angle
Description
Changes of kyphosis angle as determined by angle measurement
Time Frame
At baseline and after 16 weeks (i.e. over 16 weeks)
Title
Functional capacity
Description
Changes in Chair-Rise-Test
Time Frame
At baseline and after 16 weeks (i.e. over 16 weeks)
Title
Pulmonary function
Description
Changes in vital capacity as determined by a pulmonary function monitor
Time Frame
At baseline and after 16 weeks (i.e. over 16 weeks)
Title
Everyday life skills
Description
Changes of everyday life skills as determined by a questionnaire (late-life function and disability instrument)
Time Frame
At baseline and after 16 weeks (i.e. over 16 weeks)
Title
Balance capacity
Description
Changes in Body Sway as determined by a balance sensor device
Time Frame
At baseline and after 16 weeks (i.e. over 16 weeks)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Higher incidence of osteopenia in female population
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kemmler, PhD
Organizational Affiliation
Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Medical Physics University of Erlangen-Nurnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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