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

Not Applicable

Completed

• Conditions: Kyphosis; Osteopenia
• Interventions: Other: Spinomed active

• Registration Number: NCT04854629
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-07
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-22
• Primary Completion: 2021-12-15
• Status Verified: 2022-01
• Study Completion: 2022-01-15
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinomed active orthosis	Spinomed active	Wearing the orthosis for 16 weeks

Primary Outcome Measures

Name	Time	Method
Back pain	At baseline and after 16 weeks (i.e. over 16 weeks)	Change in back pain (mean intensity over 4 weeks on the "numeric pain scale (NPS) "0-10").

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Medical Physics University of Erlangen-Nurnberg; 🇩🇪 Erlangen, Germany