Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Vertebral Fractures.
CompletedNot applicableNCT04854629
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Osteoporotic Vertebral Bone Fracture and Hyperkyphosis.
- Conditions
- Osteopenia
- Kyphosis
- Interventions
- Other: Spinomed active
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Collaborators
- medi GmbH & Co. KG, Bayreuth, Germany
- Start date
- 2021-04-07
- Primary completion
- 2021-12-15
- Sex
- Female
- Age range
- from 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Germany
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04854629