"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"
NCT ID: NCT02536274
Last Updated: 2015-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
80 participants
INTERVENTIONAL
2015-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients have to pass a course with 6 different exercises in which they have to carry out certain activities of daily life under controlled conditions to examine, if the particular technical aid has a positive impact on pain-related activation of the back muscles.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aim of the study is to analyze systematically the effect of the dynamic flexion orthosis Dynaflex® and of the back bandage Lumbo Sensa® on the activation of the back muscles via surface EMG. On the one hand it shall be proven that the analyzed technical aids have an immediate impact on the activation of the back muscles which reduces the pain symptoms continuously. On the other hand it shall be demonstrated that surface EMG is a suitable approach to examine the effect of technical aids on the muscular activation of the back muscles focusing everyday situations or movements for the first time. From the results it shall be concluded on the everyday effect of orthosis or bandages for the discharge of the back muscles.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Schwertbad Aachen
20 Patients with specific back pain will get Lumbo Sensa® bandage. Study related procedures include a course with 6 exercises which shall be performed at the beginning and completion of the intervention: standing upright for 60s, keeping the upper body statically bent forward 40 degrees for 30s, carrying weight (1 kg) over a circular trajectory 3 times, stairs up and down for 60s, Chair rising test for 30s and 6 minutes walking test at the beginning and the end of the course. In addition, surface electromyogram (EMG) of the back muscles via surface electrodes during the course exercises will be recorded. Study procedures are the same for all study groups.
Lumbo Sensa® bandage
Patients have to wear it over 21-28 days for at least 8 hours a day
Schön Klinik Fürth
20 Patients with specific back pain will get Dynaflex® flexion orthosis. Study related procedures include a course with 6 exercises which shall be performed at the beginning and completion of the intervention: standing upright for 60s, keeping the upper body statically bent forward 40 degrees for 30s, carrying weight (1 kg) over a circular trajectory 3 times, stairs up and down for 60s, Chair rising test for 30s and 6 minutes walking test at the beginning and the end of the course. In addition, surface electromyogram (EMG) of the back muscles via surface electrodes during the course exercises will be recorded. Study procedures are the same for all study groups.
Dynaflex® flexion orthosis
Patients have to wear it over 21-28 days for at least 8 hours a day
Schön Klinik Fürth & Schwertbad Aachen
20 Patients with specific back pain will get no intervention. Study related procedures include a course with 6 exercises which shall be performed at the beginning and completion of the intervention: standing upright for 60s, keeping the upper body statically bent forward 40 degrees for 30s, carrying weight (1 kg) over a circular trajectory 3 times, stairs up and down for 60s, Chair rising test for 30s and 6 minutes walking test at the beginning and the end of the course. In addition, surface electromyogram (EMG) of the back muscles via surface electrodes during the course exercises will be recorded. Study procedures are the same for all study groups.
No interventions assigned to this group
RPE
20 healthy Subjects of the same age without back pain participate in the course for one time to prove the significance of the procedures. (control group) Study related procedures include a course with 6 exercises: standing upright for 60s, keeping the upper body statically bent forward 40 degrees for 30s, carrying weight (1 kg) over a circular trajectory 3 times, stairs up and down for 60s, Chair rising test for 30s and 6 minutes walking test at the beginning and the end of the course. In addition, surface electromyogram (EMG) of the back muscles via surface electrodes during the course exercises will be recorded. Study procedures are the same for all study groups.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lumbo Sensa® bandage
Patients have to wear it over 21-28 days for at least 8 hours a day
Dynaflex® flexion orthosis
Patients have to wear it over 21-28 days for at least 8 hours a day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Reha-Klinik Schwertbad
UNKNOWN
Schön Klinik Nürnberg Fürth
UNKNOWN
RWTH Aachen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat.
Role: PRINCIPAL_INVESTIGATOR
Head: Dept. of Rehabilitation and Prevention Engineering, Institute of Applied Medical Engineering RWTH Aachen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rehaklinik Schwertbad Aachen
Aachen, , Germany
Dept. of Rehabilitation- and Prevention Engineering, Institute of Applied Medical Engineering, Helmholtz Institute of RWTH Aachen University & Hospital
Aachen, , Germany
Spinal Surgery Center, Schön Klinik Nürnberg Fürth
Fürth, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat.
Role: CONTACT
Phone: +49 241 80 87011
Email: [email protected]
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
V Misch, Dr.med.
Role: primary
Klaus J. Schnake, Dr. med.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14-164
Identifier Type: -
Identifier Source: org_study_id