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"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"

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ClinicalTrials.gov Identifier: NCT02536274
Recruitment Status : Unknown
Verified August 2015 by RWTH Aachen University.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Collaborators:
Reha-Klinik Schwertbad
Schön Klinik Nürnberg Fürth
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:

Aim of the study is to analyze systematically by using surface EMG the effect of the dynamic flexion orthosis Dynaflex® and the back bandage Lumbo Sensa® on the voluntary activation of the low back muscles and thereby on the muscles' stiffness.

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.


Condition or disease Intervention/treatment Phase
Back Pain Device: Lumbo Sensa® bandage Device: Dynaflex® flexion orthosis Not Applicable

Detailed Description:

Usually low back pain is accompanied by male and prolonged activation of the back muscles through the Central Nervous System. It has been proved that this male innervation pattern are often related to a to the spine asymmetrical muscular activation. Biomechanically, both the asymmetric muscular activation as well as the prolonged activation of the muscles causes additional stress to the already damaged structures resulting in additional pain. Technical aids like back orthoses or bandages are supposed to relax the painful muscles and reduce pain in this way. However, no studies are available which analyze systematically the effect of such technical aids on the activation pattern of the back muscles.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Low Back Pain" and "Examination of the Impact of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Low Back Pain"
Study Start Date : September 2015
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: 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.
Device: Lumbo Sensa® bandage
Patients have to wear it over 21-28 days for at least 8 hours a day

Experimental: 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.
Device: Dynaflex® flexion orthosis
Patients have to wear it over 21-28 days for at least 8 hours a day

No Intervention: 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 Intervention: 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.



Primary Outcome Measures :
  1. change in activation of the lumbar muscles at everyday movements on targeted application of technical aids such as dynaflex® or LumboSensa® at 1 month assessed by questionnaires [ Time Frame: 1 month ]
    questionnaires: EQ-5D™, ZCQ, VAS, OLBPDQ and questionnaire about intake of analgesics

  2. change in activation of the lumbar muscles at everyday movements on targeted application of technical aids such as dynaflex® or LumboSensa® at 1 month assessed by course exercises [ Time Frame: 1 month ]
    course: 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


Secondary Outcome Measures :
  1. change in muscular activation due to specific back pain on surface EMG [ Time Frame: 1 month ]
    surface electromyogram (EMG) of the back muscles via surface electrodes during the course exercises will be recorded

  2. change in muscular activation regarding everyday life on EQ-5D™ [ Time Frame: 1 month ]
    EQ-5D™ (EuroQol-5 Dimension)

  3. change in muscular activation regarding everyday life on ZCQ [ Time Frame: 1 month ]
    Zürich Claudication Questionnaire (ZCQ)

  4. change in muscular activation regarding everyday life on VAS [ Time Frame: 1 month ]
    visual analog scale (VAS)

  5. change in muscular activation regarding everyday life on OLBPDQ [ Time Frame: 1 month ]
    Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)

  6. change in muscular activation regarding everyday life on questionnaire about intake of analgesics [ Time Frame: 1 month ]
  7. change in muscular coordination of back muscles on a course with 6 exercises [ Time Frame: 1 month ]
    course: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536274


Contacts
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Contact: Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat. +49 241 80 87011 Disselhorst-klug@ame.rwth-aachen.de

Locations
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Germany
Rehaklinik Schwertbad Aachen
Aachen, Germany, 52066
Contact: V Misch, Dr.med.    +49 241 6002 257    v.misch@schwertbad.de   
Sub-Investigator: V Misch, Dr. med.         
Dept. of Rehabilitation- and Prevention Engineering, Institute of Applied Medical Engineering, Helmholtz Institute of RWTH Aachen University & Hospital
Aachen, Germany, 52074
Principal Investigator: Catherine Disselhorst-Klug, Univ.-Prof. Dr.         
Sub-Investigator: L Igova         
Spinal Surgery Center, Schön Klinik Nürnberg Fürth
Fürth, Germany, 90763
Contact: Klaus J. Schnake, Dr. med.    +49 911 9714 1700    kschnake@schoen-kliniken.de   
Principal Investigator: Klaus J. Schnake, Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
Reha-Klinik Schwertbad
Schön Klinik Nürnberg Fürth
Investigators
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Principal Investigator: Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat. Head: Dept. of Rehabilitation and Prevention Engineering, Institute of Applied Medical Engineering RWTH Aachen University
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02536274    
Other Study ID Numbers: 14-164
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms