"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"

NCT02536274 | Unknown

• 1 other identifier: 14-164
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (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 questionnaires

  questionnaires: EQ-5D™, ZCQ, VAS, OLBPDQ and questionnaire about intake of analgesics

  1 month

• 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

Secondary Outcomes (7)

• change in muscular activation due to specific back pain on surface EMG

  1 month

• change in muscular activation regarding everyday life on EQ-5D™

  1 month

• change in muscular activation regarding everyday life on ZCQ

  1 month

• change in muscular activation regarding everyday life on VAS

  1 month

• change in muscular activation regarding everyday life on OLBPDQ

  1 month

Study Arms (4)

Schwertbad Aachen

EXPERIMENTAL

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

Schön Klinik Fürth

EXPERIMENTAL

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

Schön Klinik Fürth & Schwertbad Aachen

NO INTERVENTION

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.

RPE

NO INTERVENTION

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.

Interventions

Lumbo Sensa® bandage DEVICE

Patients have to wear it over 21-28 days for at least 8 hours a day

Schwertbad Aachen

Dynaflex® flexion orthosis DEVICE

Patients have to wear it over 21-28 days for at least 8 hours a day

Schön Klinik Fürth

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Reha-Klinik Schwertbad: collaborator
• Schön Klinik Nürnberg Fürth: collaborator

Study Sites (3)

Rehaklinik Schwertbad Aachen

Aachen, 52066, Germany

Location

Dept. of Rehabilitation- and Prevention Engineering, Institute of Applied Medical Engineering, Helmholtz Institute of RWTH Aachen University & Hospital

Aachen, 52074, Germany

Location

Spinal Surgery Center, Schön Klinik Nürnberg Fürth

Fürth, 90763, Germany

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat.

  Head: Dept. of Rehabilitation and Prevention Engineering, Institute of Applied Medical Engineering RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat.

CONTACT

+49 241 80 87011; Disselhorst-klug@ame.rwth-aachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 31, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

DE (3)