"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"

Back Pain Clinical Trial

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02536274
• Other study ID #: 14-164
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2015
• Last updated: August 26, 2015
• Start date: September 2015

Study information

• Verified date: August 2015
• Source: RWTH Aachen University
• Contact: Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat.
• Phone: +49 241 80 87011
• Email: Disselhorst-klug[@]ame.rwth-aachen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain

Intervention

Device:
• 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

Locations

Country	Name	City	State
Germany	Dept. of Rehabilitation- and Prevention Engineering, Institute of Applied Medical Engineering, Helmholtz Institute of RWTH Aachen University & Hospital	Aachen
Germany	Rehaklinik Schwertbad Aachen	Aachen
Germany	Spinal Surgery Center, Schön Klinik Nürnberg Fürth	Fürth

Sponsors (3)

Lead Sponsor	Collaborator
RWTH Aachen University	Reha-Klinik Schwertbad, Schön Klinik Nürnberg Fürth

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	questionnaires: EQ-5D™, ZCQ, VAS, OLBPDQ and questionnaire about intake of analgesics	1 month	No
Primary	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	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	1 month	No
Secondary	change in muscular activation due to specific back pain on surface EMG	surface electromyogram (EMG) of the back muscles via surface electrodes during the course exercises will be recorded	1 month	No
Secondary	change in muscular activation regarding everyday life on EQ-5D™	EQ-5D™ (EuroQol-5 Dimension)	1 month	No
Secondary	change in muscular activation regarding everyday life on ZCQ	Zürich Claudication Questionnaire (ZCQ)	1 month	No
Secondary	change in muscular activation regarding everyday life on VAS	visual analog scale (VAS)	1 month	No
Secondary	change in muscular activation regarding everyday life on OLBPDQ	Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)	1 month	No
Secondary	change in muscular activation regarding everyday life on questionnaire about intake of analgesics		1 month	No
Secondary	change in muscular coordination of back muscles on a course with 6 exercises	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	1 month	No