Back PainNCT02536274
"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"
A study testing Lumbo Sensa® bandage and Dynaflex® flexion orthosis in people with Back Pain, run by RWTH Aachen University at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Lumbo Sensa® bandage and Dynaflex® flexion orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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®:
Show all 11Show fewer
- scoliosis
- osteoporosis
- inflammatory rheumatic back pain
- Failed Back Surgery Syndrome
- painful conditions after stabilizing or reinforcing surgeries
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat. contact
Germany3 sites
Rehaklinik Schwertbad Aachen
Aachen, 52066
V Misch, Dr.med., +49 241 6002 257, v.misch@schwertbad.de
V Misch, Dr. med.
Dept. of Rehabilitation- and Prevention Engineering, Institute of Applied Medical Engineering, Helmholtz Institute of RWTH Aachen University & Hospital
Aachen, 52074
Catherine Disselhorst-Klug, Univ.-Prof. Dr.
L Igova
Spinal Surgery Center, Schön Klinik Nürnberg Fürth
Fürth, 90763
Klaus J. Schnake, Dr. med., +49 911 9714 1700, kschnake@schoen-kliniken.de
Klaus J. Schnake, Dr. med.
About this study
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"
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.
Read the 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
- Being tested
- Lumbo Sensa® bandage, Dynaflex® flexion orthosis
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbo Sensa® bandageDevice
Patients have to wear it over 21-28 days for at least 8 hours a day
Dynaflex® flexion orthosisDevice
Patients have to wear it over 21-28 days for at least 8 hours a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month
Secondary outcomes (7)
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
Measured: 1 month
change in muscular activation regarding everyday life on EQ-5D™
EQ-5D™ (EuroQol-5 Dimension)
Measured: 1 month
change in muscular activation regarding everyday life on ZCQ
Zürich Claudication Questionnaire (ZCQ)
Measured: 1 month
change in muscular activation regarding everyday life on VAS
visual analog scale (VAS)
Measured: 1 month
change in muscular activation regarding everyday life on OLBPDQ
Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)
Measured: 1 month
change in muscular activation regarding everyday life on questionnaire about intake of analgesics
Measured: 1 month
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Reha-Klinik Schwertbad, Schön Klinik Nürnberg Fürth
- Responsible party
- Sponsor
- Investigators
- Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat., Principal investigator, Head: Dept. of Rehabilitation and Prevention Engineering, Institute of Applied Medical Engineering RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536274
- Sponsor's protocol ID
- 14-164
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT02536274
- Acronym / sponsor ID
- 14-164
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Reha-Klinik Schwertbad, Schön Klinik Nürnberg Fürth
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Schwertbad Aachen | Experimental | Device: Lumbo Sensa® bandage20 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. |
| Schön Klinik Fürth | Experimental | Device: Dynaflex® flexion orthosis20 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- scoliosis
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbo Sensa® bandagePatients have to wear it over 21-28 days for at least 8 hours a day | Device | Schwertbad Aachen |
| Dynaflex® flexion orthosisPatients have to wear it over 21-28 days for at least 8 hours a day | Device | Schön Klinik Fürth |
Primary outcome
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
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
7 secondary outcomes
change in muscular activation due to specific back pain on surface EMG
Time frame: 1 month
change in muscular activation regarding everyday life on EQ-5D™
Time frame: 1 month
change in muscular activation regarding everyday life on ZCQ
Time frame: 1 month
change in muscular activation regarding everyday life on VAS
Time frame: 1 month
change in muscular activation regarding everyday life on OLBPDQ
Time frame: 1 month
change in muscular activation regarding everyday life on questionnaire about intake of analgesics
Time frame: 1 month
change in muscular coordination of back muscles on a course with 6 exercises
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat. contact
Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat. principal investigator
Head: Dept. of Rehabilitation and Prevention Engineering, Institute of Applied Medical Engineering RWTH Aachen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbo Sensa® bandage and Dynaflex® flexion orthosis in people with Back Pain, run by RWTH Aachen University at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Disselhorst-Klug, Univ.-Prof. Dr. rer. nat. (+49 241 80 87011, Disselhorst-klug@ame.rwth-aachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.