Effect of Regular Electrotherapy in Patients With Chronic Non-specific Neck Pain and Low-back Pain: a Randomized Controlled Double-blinded Pilot Trial
Phase: NA
Conditions: Chronic Low-back Pain, Chronic Pain, Back Pain Without Radiation
Sponsor: Medical University of Vienna

StimaWELL® in patients with chronic neck- and low-back 
pain 
 
Version 6.0 on 25.08.2017 
 
1 
 
 
 
Study protocol 
 
 
 
 
Effectiveness of  mid-frequent electrotherapy  StimaWELL® in patients with 
chronic neck- and low-back pain 
 
 
 
 
 

StimaWELL® in patients with chronic neck- and low-back 
pain 
 
Version 6.0 on 25.08.2017 
 
2 
 
 
Table of contents 
 
Summary ............................................................................................................................................... 33
 ................................................................................................................................................................. 3 
Type of the study ................................................................................................................................... 44
 ................................................................................................................................................................. 4 
Material and methods ......................................................................Fehler! Textmarke nicht definiert.4
 ............................................................................................................ Fehler! Textmarke nicht definiert. 
Inclusion criteria ............................................................................................................................ 66
 ......................................................................................................................................................... 6 
Exclusion criteria ........................................................................................................................... 67
 ......................................................................................................................................................... 6 
Management of complications and aftercare ............................................................................... 77
 ......................................................................................................................................................... 7 
Benefits for study participants ...................................................................................................... 77
 ......................................................................................................................................................... 7 
Ethical considerations ........................................................................................................................... 77
 ................................................................................................................................................................. 7 
Time shedule ......................................................................................................................................... 88
 ................................................................................................................................................................. 8 
Study-related measures ........................................................................................................................ 99
 ................................................................................................................................................................. 9 
Evaluation of personal data and medical history ...................Fehler! Textmarke nicht definiert.10
 .................................................................................................... Fehler! Textmarke nicht definiert. 
Questionnaires for recording the quality of life (QoL), subjective pain perception and 
functionality .............................................................................................................................. 1010
 ....................................................................................................................................................... 10 
Application of StimaWELL® ....................................................................................................... 1010
 ....................................................................................................................................................... 10 
Statistical analysis  ..................................................................................................................... 1111
 ....................................................................................................................................................... 11 
Literature ........................................................................................................................................... 1111
 ............................................................................................................................................................... 11 
 
 

StimaWELL® in patients with chronic neck- and low-back 
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Summary 
 
Transcutaneous electrical nerve stimulation (TENS) is widely used in everyday clinical practice for 
both acute and chronic pain. One of the main indications for the use of TENS is musculoskeletal pain 
(Johnson and Martinson, 2007). Especially in  chronic low-back pain  (Shimoji et al, 2007; Pop et al, 
2010; Buchmuller et al, 2011; Facci et al, 2011; Ratajczak et al., 2011) and  Cervicalgia  (Maayah and 
Al-Jarrah 2010) the effectiveness of TENS has been shown several times in the literature, although no 
clear benefit could be proven in larger systematic reviews or  meta-analyses,  neither for cervical 
syndrome (Machado et al, 2009; Kroeling et al., 2013), nor for lumbargia (Khadilkar et al., 2008; Van 
Middelcoop et al. ,  2011). In the use of TENS with sufficiently high stimulation intensities, a reduced 
need for opioids and less opioid-induced adverse reactions have been observed (Wang et al.,  1997; 
Chen et al, 1998). 
The aim of this study is to assess the effect of the application of regular, mid-frequent electrotherapy 
on chronic neck- or low-back pain. This electrode mat used in the study is larger than the electrode 
patches of conventional TENS devices, and covers the entire spine. The patients are  interviewed 
anamnestically and physically examined before and after the application of the device regarding the 
subjektive pain sensation (Numeric pain rating scale, Shortform-Mc Gill Pain Questionnary  incl. 
Visual analogue scale) and the functionality in everyday life using questinnonaires (Roland-Morris 
Disabilty Questionnaire, Neck Disability Index). Furthermore, the spine mobility (i.e. the range of 
motion) of the cervical and lumbar region is also determined before and after the sessions. 

StimaWELL® in patients with chronic neck- and low-back 
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Type of the study 
 
The study is a prospective, monocentric, double-blind, randomized and controlled study.  
 
Primary outcome: 
- Is there a significant difference in the Visual Analogue Scale (VAS)/Numeric rating scale (NRS) of 
patients with neck- and low-back pain before and after application of StimaWELL®  between verum,  
control group, and control of the control group)?  
 
Secondary outcomes: 
- Is there a significant difference in the individual pain qualities (SF-MPQ), in the  Roland-Morris 
Disabiltiy Questionnaire, in the Neck Disability Index,  in the spinal range of motion (ROM) in chronic 
neck- or low-back pain patients  after application of StimaWELL®  compared to the  control group and 
control of control group?   
- Are there gender-specific differences regarding the effect of StimaWELL® regarding. SF-MPQ, in the 
Roland-Morris Disability Index, Neck-Disability Index or  ROM? 
- Does  the use of StimaWELL®  change the need for painkillers (WHO level II, WHO level III drugs)? 
 
Material and methods 
 
The study will test 125  patients  (equivalent to 50 patients in the verum group, 50 patients in the  
control group, as well as 25 patients in control of the control group) in the pain outpatient clinic of 
the University Clinic for Anesthesia, General Anesthesia and Special Pain Therapy. The patients are  
recruited from the respective  outpatient clinics, by extramural ordinations or libraries by means of 
flyers, and were asked to contact the e-mail address  studie_elektrotherapie@hotmail.com  for  
preliminary examination. As a next step they are randomized into three different groups: “Verum 
group” with superliminal mid-frequency stimulation for 30 min after device calibration, “control 
group” with Sham treatment with device calibration only without consequent electrostimulation, or 
“control of the control group” without any stimulation. During the preliminary examination, all 
patients, regardless whether they have been recruited by public libraries or extramural ordinations, 
are examined by trained medical staff in respect to the inclusion and exclusion criteria. Patients who 
are eligible to participate in the study are then assigned to the six-time weekly sessions for 30 min 
each, and for follow-up examination. 
The recruitment of patients were performed in the pain clinic of the University Clinic for Anesthesia, 
in the University Clinic for Physical Medicine and Rehabilitation in the Medical University of Vienna, 
as well as by the following extramural ordinations and public libraries by means of advertising flyers: 
• 
University Library of the Medical University of Vienna 

StimaWELL® in patients with chronic neck- and low-back 
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• 
Entrance hall/pinboards on level 5 and pinboards on level 4, levels 7 and 8 of the Medical 
University of Vienna 
• 
Orthopaedics Donauzentrum Dr. Bernhard Gisinger/Dr. Michaela Huber, Donaustadtstraße 1, 
1220 Vienna 
• 
Dr. Christoph Katzenschlager, ENTObere Landstraße 3, 3500 Krems 
• 
Dr. Susanne Kuta, Jägerstraße 41/1, 1200 Vienna, +43-1-3327029 
• 
Dr. Herbert Ledermüller, Friedrich-Engels-Platz 10/3, 1200 Vienna, Tel. +43-1-3304143 
• 
Dr. Marcus Merhaut, Vorgartenstraße 86/1/5, 1200 Vienna, Tel. +43-1-3329245 
• 
Dr. Susi Pachala, Rauscherstraße 2/8, 1200 Vienna, Tel. +43-1-3327237 
• 
Dr. Johanna Palkovits, Winarskystraße 18/5/5, 1200 Vienna, Tel. +43-1-3322033 
• 
Medical Councillor Dr. Monika Pfau, Dresdner Straße 49, 1200 Vienna, Tel. +43-1-3309566 
• 
Dr. Michael Schweitzer, Jägerstraße 64/2/1/2, 1200 Vienna, Tel. +43-1-3303212 
• 
Dr. Stefan Michael Sonnleitner, Pappenheimgasse 37, 1200 Vienna, Tel. +43-1-3304393 
• 
Dr. Johann Weiss, Pappenheimgasse 31/13/2, 1200 Vienna, Tel. +43-1-3328573 
• 
Dr. Thomas Berger, Marchfeldstraße 16-18/1, 1200 Vienna, Tel. +43-1-3322376 
• 
Medical Councillor Dr. Ingeborg Calvi, Romanogasse 21-23, 1200 Vienna, Tel. +43-1-3303460 
• 
Dr. Basil Dabbass, Kluckygasse 17/7, 1200 Vienna, Tel. +43-1-3300213 
• 
Dr. Renate Kastner-Fried, Grundlgasse 5/8, 1090 Vienna, Tel. +43-1-22887700 
• 
Dr. Hai-Duong Nguyen-Huber, Grünentorgasse 10/3, 1090 Wien, Tel. +43-1-3197212 
• 
Dr. Rudolf Christian Rauch, Währinger Straße 60, 1090 Vienna, Tel. +43-1-3108978 
• 
Dr. Paul Groß, Gallitzinstraße 64, 1160 Vienna, Tel. +43-1-9146583 
• 
Dr. Wilhelm Prosche, Thaliastraße 125A/1/2, 1160 Vienna, Tel. +43-1-4947899 
• 
Dr. Christoph Scherer, Geblergasse 53, 1170 Vienna, Tel. +43-1-4059278 
• 
Dr. Birgit Brandner, Gersthofer Straße 162, 1180 Vienna, Tel. +43-1-9081204 
• 
Medical Advisor Dr. Johannes Capek, Gentzgasse 117/29, 1180 Vienna, Tel. +43-1-4793177 
• 
Dr. Renate Hoffmann-Dorninger, Gymnasiumstraße 20/1, 1180 Vienna, Tel. +43-1-4796663 
• 
Dr. Elise Norden-Wainig, Hans-Sachs-Gasse 29, 1180 Vienna, Tel. +43-1-4087815 
• 
Dr. Barbara Nowatschek, Johann-Nepomuk-Vogl-Platz 1/5, 1180 Vienna, Tel. +43-1-4060107 
• 
Dr. Ingrid Rapatz, Thimiggasse 17, 1180 Vienna, Tel. +43-1-3694222 
• 
Dr. Lucia Schachinger, Gentzgasse 6, 1180 Vienna, Tel. +43-1-4796133 
• 
Dr. Margarete Mikhail, Döblinger Hauptstraße 87/2, 1190 Vienna, Tel. +43-1-3687743 
• 
Dr. Evemarie Wolkenstein, Weinberggasse 1, 1190 Vienna, Tel. +43-1-3195944 
• 
Dr.  Thomas J.A.  Rodler,,Sellenygasse 5, 1020 Vienna, Tel. +43-‐1-‐8901564 
• 
Dr.  Hugo Gold, Taborstraße 59/7, 1020 Vienna, Tel. +43-‐1-‐2163949 
• 
MR Dr.  Erich Lemberger, Tandelmarktgasse 22-‐24/2, 1020 Vienna, Tel. +43-‐1-‐2146764 
• 
Dr.  Elyahi Tamir, Raimundgasse 1/1/2, 1020 Vienna, Tel. +43-1-2146 
• 
Dr.  Sanja Annemarie Sharaf, Kegelgasse 4/6, 1030 Vienna, +43‐1‐7132277 
• 
Dr.  Birgitta Gisperg, Weyringergasse 28 A/Door 5, 1040 Vienna, +43‐1‐5047437 
• 
Dr.  Andreas Kurzreiter, Schelleingasse 26/3/Top 1-4, 1040 Vienna, Tel. +43‐15043330 
• 
Dr.  Ewald Alexander Steffal, Wiedner Hauptstraße 139, 1050 Vienna, Tel. +43‐1‐5444401 
• 
Dr.  Andrea Cornelia Hurch-Rath, Meravigliagasse 8, 1060 Vienna, Tel. +43-1-596651 
• 
Dr.  Elisabeth Ita Maranitsch, Gumpendorfer Straße 63 D/3, Phone +43-1-587272  
• 
Dr.  Marcus Franz, Hietzinger Hauptstr. 71/6, 1130 Vienna, Tel. +43-187792  
• 
Dr.  Ruth Michael, Ottakringer Straße 35/5A, 1160 Vienna +43-1-4050116 
• 
Dr.  Wolfgang Sperrer, Neulerchenfelder Straße 4/1/4, 1160 Vienna, Tel. -43-1-406412 
• 
Dr.  Mazen Linecker-‐Al-‐Shakarchi, Thaliastraße 105/1/8, 1160 Vienna, Tel. +43-1-492407  
• 
Dr.  Reihaneh Behrus, Koppstraße 43/2-‐3, 1160 Vienna, Tel. +43-1-495444 
• 
Dr.  Monika Cronenberg, Hernalser Hauptstr.  89/3, 1170 Vienna, Tel. +43-1-486228  
• 
Dr.  Monika Burkart, Rosensteingasse 68/9, 1170 Vienna, Tel. +43-1-485618 
• 
Dr.  Karin Kain, Kalvarienberggasse 66, 1170 Vienna, Tel. +43‐1‐4081411 

StimaWELL® in patients with chronic neck- and low-back 
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• 
Dr.  Gerlinde Harter, Marktstraße 17, 2851 Krumbach, +43-2647-422 
• 
likes.  Michentha, Stadt-‐ApothekeGroß-‐Enzersdorf, Kirchenplatz 16, Groß-‐Enzersdorf, Tel. 
+43-2249-271 
 
The calculation of the number of cases is based on the primary endpoint. To achieve a power of 80%, 
using the t-test for unpaired samples, n-number of 37 patients per group is needed for the verum 
and control group, respectively, assuming that the difference in the change in the VAS/NRS score 
between the two groups is exactly 10 (VAS) or 1 point (NRS), and n-number of 10 in the control of 
control group, assuming that there is no significant change in the VAS/NRS score before and after the 
sessions. Based on the study by Pop et al. 2010, a standard deviation of 1.5 (for NRS) was assumed. In 
order to correct for possible drop-outs (about 30 %), the number of cases is increased to 50 patients 
per in the verum and control group each, and to 25 patients in the control of control group. The 
statistical evaluation is carried out with the help of SPSS. 
There is no payment of the study patients provided. All study participants are insured via Zürich 
Versicherungs-Aktiengesellschaft, policy number  07229622-2. 
 
Inclusion criteria 
- 
Women and men aged at least  18 years, who have been suffering from pain and/or tension 
in the  cervical, thoracic  or lumbar spine for at least 3 months without radicular involvement 
or pain radiating into the arms or legs.   
- 
From a scale of 0 to 10, the subjectively perceived pain intensity (numeric pain rating scale, 
NRPS) should be > 5.  
- 
Current laboratory values incl. complete blood count and inflammation values, as well as an 
X-ray of the spine (anterior/posterior and lateral, functional images), each not older than 
max. 3 months, should be used to ensure the work diagnosis  (myalgia, spondylarthrosis, 
spondylolistheses, sacroileitis, etc.) and to verify the exclusion criteria. 
- 
The pain medication must have remained constant 2 weeks before the start of the study and 
must not be changed during  the study period. 
- 
Non-oral pain therapies such as physiotherapy, physical therapy, acupuncture, manual 
therapy, osteopathy, etc. must be completed at least 2 weeks before the start of the study 
and may not be carried out additionally during the study period. 
- 
None of the  following exclusion criteria should apply: 
 
Exclusion criteria 
- 
Pregnancy 
- 
Participation in other studies (anamnestic query) 
- 
Pretreatment with TENS (transcutaneous electrical nerve stimulation; for the purpose of risk 
of unblinding) 
- 
Ongoing pension procedure (in order to avoid bias due to pretension of illness; anamnestic 
query) 

StimaWELL® in patients with chronic neck- and low-back 
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- 
Neuropathic, radicular  pain (anamnestic query) 
- 
Acute instabilities and/or surgical indication in the spine (e. g. sudden loss of strength, acute 
problems with urination or defecation, riding pants hypoesthesia) 
- 
Previous spine surgery 
- 
Infections/abscesses/skin lesions in the spine or the surrounding area 
- 
Malignant diseases or secondary blastomas in the spine or in the surrounding area 
- 
Change in the pain therapy the last 4 weeks (e. g. intravenous infusions, local infiltrations, 
peridural anesthesia or other invasive procedures in the close vicinity of the spine, physical 
treatments, change of the oral drug therapy) 
- 
Cardiac arrhythmias, implanted pacemaker or defibrillator, previous heart surgery 
- 
Epilepsy 
 
Managementof complications and aftercare 
Patients receive a written information sheet with the contact details of the study leaders in order to 
be able to report any  undesirable effect.   
 
Benefits for study participants 
The advantage of the patients  is the intensified medical and physical care during the study, as well as 
the option to receive further treatments with StimaWELL® in the Pain Outpatient Clinic after the 
study partcipation. 
 
Ethical considerations 
 
StimaWELL® is a form of electrotherapy, based on the TENS device widely used in everyday clinical 
practice,   and  ist  not-invasiv,cost-effective, easy to perform, low side effect,  and  takes  only  
approx.   30  minutes per application. Analogous to the TENS device, a painkiller requirement 
reducing effect is expected after repeated application. 
The duration of the total examination ofabout one hour  and follow-up evaluation of 60 
minuteseach, as well as   6 therapy units of 30 minutes per patient at weekly intervals,  can be 
regarded as less stressful. 
There are no additional invasive measures beyond  the normaln  outpatient  measures  (e.B. X-ray 
examination, bloodsampling). For these reasons, no risks for the study participants are to be 
expected. 
The consent ofthe study participants is given by means of an information sheet and detailed oral 
information. 
 
 

StimaWELL® in patients with chronic neck- and low-back 
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Time shedule 
 
All examinations (anamnesis incl. personal data collection and assessment of the past medical 
history, physical examination, quesionnaires about the funcionality in daily life, quality of life, and 
measurement of the spine mobility) can be carried out within about an hour in total. The  application 
of StimaWELL® does not exceed about an hour (about 30 minutes on average). 
 
Actionn 
Number of 
treatments/sessions 
Required 
time 
anamnesis 
1x 
about 10  
minutes 
Survey of the subj. Pain perception by means of 
questionnaire (SF-MPQ incl. VAS) 
2x (before and after  6 
units StimaWELL®) 
about 10 
minutes 
Survey of functionality in everyday life by means of 
questionnaires (Roland-Morris Disability 
Questionnaire, Neck Disability Index) 
2x  (before and after 6 
units StimaWELL®) 
about 20 
minutes 
Examination of the spinal mobility (ROM) 
2x  (before and after 6 
units StimaWELL®) 
about 10 
minutes 
Application of StimaWELL® or Sham treatment 
6x 
about 30 
minutes 
Evaluation of medication intake 
2x  (before and after 6 
units StimaWELL®) 
about 5 
minutes 

StimaWELL® in patients with chronic neck- and low-back pain 
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Time Shedule 
 
 
 
 
 
  
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8 
First contact in 
the outpatient 
clinic, patient 
recruitment 
Basic 
investigation (SF-
MPQ incl. 
VAS/NRS, ROM, 
RMDQ, NDI, 
medication) 
 
  
  
  
  
Final investigation 
(SF-MPQ incl. 
VAS, ROM, 
RMDQ, NDI, 
medication) 
  
 
Session 1 
(verum/ 
control/ 
control of 
control) 
Session 2 
(verum/ 
control/ 
control of 
control) 
Session 3 
(verum/ 
control/ 
control of 
control) 
Session 4 
(verum/ 
control/ 
control of 
control) 
Session 5 
(verum/ 
control/ 
control of 
control) 
Session 6 
(verum/ 
control/ 
control of 
control) 
  

StimaWELL® in patients with chronic neck- and low-back pain
 
 
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Study-related measures 
 
At the beginning of the study, a detailed explanation is performed by means of an information sheet 
and an informed consent is obtained. After a basic investigation (anamnesis inkl. collection of 
personal data and medical history, physical examination and quesionnaires), patients were 
randomized into one of the three gourps (verum, control, control of control). Weekly sessions withor 
without electrostimulation for 30 min each and six times in total are then performed. In the end,  the 
same investigations performed at the beginning of the study are repeated and patients were asked 
for any unvoluntary effects during the study. The basic, as well as the final investigation consist of the 
following: 
 
Evaluation of personal data and medical history 
• 
Collection of personal data 
• 
Evaluation of the actual pain state (in rest, under activity, average in the last 4 weeks, 
minimum, maximum) using NRS 
• 
Current or previous illnesses or surgeries 
• 
Concomitant medication 
 
Questionnaires for recording the quality of life (QoL),  subjective pain perception and  
functionality 
The survey of the quality of life,the subjective sensation of pain, as well as the functionality in 
everyday life is carried out  with the means of validated  questionnaires (SF-MPQ:  subjective pain 
relief;  Roland-Morris Disability Questionnaire/Neck Disability Index: Questioning functionality in 
everyday life). The  mobility (range of motion) of the cervical and lumbar spine is based on  validated 
tests (modified-modified  Schober: Williams et al., 1993; Tousignant et al., 2005; Performance 
Attainment Associates CROM: see Tousignant et al., 2000; Williams et al., 2010). 
 
Application of StimaWELL® 
StimaWELL® is a multidimensional, dynamic deep stimulation device from Schwa-medico, which is an 
electrode mat consisting of 12 bilateral stimulation bars. Mid-frequent electrotherapy  (2-6 kHz) can 
be applied, also in comination with heat application and mechanical stimulation (massage) if desired. 
According to the company, StimaWELL® can be used in acute and chronic pain in the spine  with or 
without degenerations detectable in X-ray or MRI such as osteochondrosis, spondylarthrosis, 
spondylolisthesis, intervertebral disc protrusions, lumbar spinal canal stenosis, as well as  in 
osteoporosis.  
In accordance with the Medical Devices Directive 93/42/EEC, the device bears the CE marking 
CE0482. StimaWELL® Is used in the study according to the indication specified by the manufacturer, 
namely  pain treatment in the spine area, in consideration of the contraindications (see exclusion 
criteria).   

StimaWELL® in patients with chronic neck- and low-back pain
 
 
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Patients who have been assigned into the verum group receive a suprathreshold stimulation for 30 
minutes in each session, which remains subjectively clearly noticeable. In the control group, the 
device is initially set for device calibration and then switched off (= sham therapy), in the control of  
control group, the device is kept inactivated from start to finish of the session; to avoid unblinding of 
the patient, the display is covered with a blanket after device setting so that it can’t be seen by the 
patients. 
 
Statistical analysis 
Data is evaluated using Sigma Plot version 12.0 from Systat Software GmbH and SPSS® version 19 
from IBM. The  demographic data are divided into the following variables and presented: 
- 
Qualitative variables (e.B. gender): absolute frequency in %, calculated separately for verum 
control  and  control of the control group 
- 
Quantitative variables (e.B. age, NRS, VAS, ROM): mean + standard deviation, median, 
minimum, maximum; calculated for verum and control and control of the control group 
Primary parameters: 
Is there a difference in VAS/NRS between the verum and control groupn  after the application of 
StimaWELL®? 
Mean and standard deviation, minimum, maximum and median for the difference between the pre- 
and post values are calculated separately for all  groups. Statistically significant difference is checked 
with the help of the t-test for unpaired samples. A significance level of alpha = 5% (two-sided) is 
used. 
Secondary parameters (e.B. differences in the individual pain qualities in the SF-MPQ; gender-specific 
differences in SF-MPQ, Roland-Morris Test/Neck Disability Index, ROM; Change in drug dosage) are 
analyzed using RM-One Way ANOVA and Bonferroni correction. 
The data of the patients used are pseudonymized. The  completeness of the entries (e.B. patient 
number and initials on each sheet of the CRF) is controlled  after testing and transfer to the online 
form (Clincase) or to Excel developed by the Statistics Institute. The data is transferred to Excel 
sheets, backed up electronically 2 times at least and printed out once. An interim evaluation in half of 
the study is planned to check the statistical fluctuation and the dropout rate. 
Literature 
 
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Laurent B, Camdessanché JP;  Lombotens Trial Group. Value of TENS for relief of chronic low 
back pain with or without radicular pain.  Eur J Pain.  2011; 16(5):656-65. 
 
2. Chen L, Tang J, White PF, Sloninsky A, Wender RH, Naruse R, Kariger R. The effect of location 
of transcutaneous electrical nerve stimulation on postoperative opioid analgesic 
requirement: acupoint versus nonacupoint stimulation.  Anesth Analg.  1998;87(5):1129-34. 
 

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15. Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the 
intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic 
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