Clinical trial: "Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain" (NCT02536274)

Eligibility criteria:
Inclusion Criteria:

        for the application with Dynaflex®:

          -  central or foraminal lumbar stenosis, Claudicatio spinalis pathology

          -  degenerative lumbar instability (e.g. Spondylolisthesis) with lumboischialgia or
             Claudicatio spinalis pathology

          -  herniated vertebral disk with forms of ischialgia pain

          -  age: 18-80 years

        additionally for the application with LumboSensa®:

          -  scoliosis

          -  osteoporosis

          -  inflammatory rheumatic back pain

          -  Failed Back Surgery Syndrome

          -  painful conditions after stabilizing or reinforcing surgeries

        Exclusion Criteria:

          -  paresis of the lower extremity

          -  contact allergy to orthotic material

          -  diseases in body regions with contact to orthosis, which become manifest
             neurologically/dermatologically

          -  acute Spondylodiscitis

          -  tumor diseases

          -  recent vertebral body fractures

          -  pregnant and lactating females

          -  subject has been committed to an institution by legal or regulatory order

          -  dependency or working relationship with the investigator

          -  participation in a parallel interventional clinical study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Contradiction