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

NCT04854629 | Completed

• 1 other identifier: Orthosis Spinomed active
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Trunk strength/performance

  At baseline and after 16 weeks (i.e. over 16 weeks)

• Kyphosis angle

  At baseline and after 16 weeks (i.e. over 16 weeks)

• Functional capacity

  At baseline and after 16 weeks (i.e. over 16 weeks)

• Pulmonary function

  At baseline and after 16 weeks (i.e. over 16 weeks)

• Everyday life skills

  At baseline and after 16 weeks (i.e. over 16 weeks)

Study Arms (2)

Spinomed active orthosis

EXPERIMENTAL

Wearing the orthosis for 16 weeks

Other: Spinomed active

Control group

NO INTERVENTION

No intervention: non spinomed active control

Interventions

Spinomed active 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

Spinomed active orthosis

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Higher incidence of osteopenia in female population
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• medi GmbH & Co. KG, Bayreuth, Germany: collaborator

Study Sites (1)

Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Kyphosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Curvatures; Spinal Diseases

Study Officials

• Wolfgang Kemmler, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor were unaware of participant status (i.e. spinomed active or control) and were not allowed to ask correspondingly
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two study groups in parallel: (1) Spinomed active orthosis or 16 weeks (2) non spinomed active orthosis control

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 22, 2021
• Study Start: April 7, 2021
• Primary Completion: December 15, 2021
• Study Completion: January 15, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available in March 2022 without time limit.

Locations

DE (1)