Clinical trial NCT02536274: "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"
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Pain
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Reha-Klinik Schwertbad
name: Schön Klinik Nürnberg Fürth
First posted: 2015-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: 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
timeFrame: 1 month
measure: 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
timeFrame: 1 month
Secondary outcomes:
measure: change in muscular activation due to specific back pain on surface EMG
timeFrame: 1 month
measure: change in muscular activation regarding everyday life on EQ-5D™
timeFrame: 1 month
measure: change in muscular activation regarding everyday life on ZCQ
timeFrame: 1 month
measure: change in muscular activation regarding everyday life on VAS
timeFrame: 1 month
measure: change in muscular activation regarding everyday life on OLBPDQ
timeFrame: 1 month
measure: change in muscular activation regarding everyday life on questionnaire about intake of analgesics
timeFrame: 1 month
measure: change in muscular coordination of back muscles on a course with 6 exercises
timeFrame: 1 month
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Rehaklinik Schwertbad Aachen
city: Aachen
country: Germany
facility: Dept. of Rehabilitation- and Prevention Engineering, Institute of Applied Medical Engineering, Helmholtz Institute of RWTH Aachen University & Hospital
city: Fürth
country: Germany
facility: Spinal Surgery Center, Schön Klinik Nürnberg Fürth
Study officials:
affiliation: Head: Dept. of Rehabilitation and Prevention Engineering, Institute of Applied Medical Engineering RWTH Aachen University
name: Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat.
role: PRINCIPAL_INVESTIGATOR
References: