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"

"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"

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Back Pain

Interventions

Type	Name	Description
DEVICE	Lumbo Sensa® bandage	Patients have to wear it over 21-28 days for at least 8 hours a day
DEVICE	Dynaflex® flexion orthosis	Patients have to wear it over 21-28 days for at least 8 hours a day

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• First posted: 2015-08-31
• Last updated: 2015-08-31

Locations

3 sites across 1 country: Germany