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

NCT ID: NCT04854629

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2022-01-15

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.

Conditions

Osteopenia; Kyphosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Spinomed active orthosis

Wearing the orthosis for 16 weeks

Group Type: EXPERIMENTAL

Spinomed active

Intervention Type: OTHER

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

Control group

No intervention: non spinomed active control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

medi GmbH & Co. KG, Bayreuth, Germany

UNKNOWN

Sponsor Role: collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Kemmler, PhD

Role: STUDY_CHAIR

Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg

Locations

Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, , Germany

Countries

Germany

Other Identifiers

Orthosis Spinomed active

Identifier Type: -

Identifier Source: org_study_id