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Completed

NCT Number: NCT04854629

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

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.

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Kyphosis Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Spinal Curvatures Spinal Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Back pain

    Time frame: 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 outcomes

  1. Trunk strength/performance

    Time frame: 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

  2. Kyphosis angle

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

    Changes of kyphosis angle as determined by angle measurement

  3. Functional capacity

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

    Changes in Chair-Rise-Test

  4. Pulmonary function

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

    Changes in vital capacity as determined by a pulmonary function monitor

  5. Everyday life skills

    Time frame: 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)

  6. Balance capacity

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

    Changes in Body Sway as determined by a balance sensor device

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • medi GmbH & Co. KG, Bayreuth, Germany

Registry information

Official study title

Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Osteoporotic Vertebral Bone Fracture and Hyperkyphosis.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 22, 2021
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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