EMS Rückensystem/ Studie Klagenfurt

EMS Rückensystem/ Studie Klagenfurt

In einer Studie des Zentrums für Interdisziplinäre Schmerztherapie und Palliativmedizin (ZISOP) am Klinikum Klagenfurt am Wörthersee wurde 2015 bis 2017 bei 100 Patienten die Wirksamkeit einer multidimensionalen dynamischen Tiefwellentherapie bei Patienten mit chronischen unspezifischen Rückenschmerzen getestet. Die Studie bestätigte die Effektivität des StimaWELL® Rückensystem zur signifikanten Schmerzminderung des Patienten am Rücken und beschreibt die multidimensionale dynamische Tiefwellentherapie als eine sehr überzeugende und sichere Methode zur Behandlung von chronischen Rückenschmerzen. Die elektrische Muskelstimulation in Kombination mit Hitze konnte für eine beachtliche Schmerzlinderung und Verbesserung der subjektiven und objektiven Daten im Vergleich zu Standardbehandlung ohne Elektrotherapie beitragen.[1]

Efficacy of mul,dimensional dynamic deep wave therapy in pa,ents with chronic non-specific low back pain: a randomized, double-blind, stra,fied, placebo controlled clinical trial Neuwersch S., Köstenberger M., Pipam W., Breschan C., SteJner H., Demschar S., Trummer B., Likar R. Introduc,on Chronic non-specific low back pain (LBP) which persists for > 12 weeks and is not aMributed to a recognisable pathology, affects more than 70% of individuals in developed countries at some 9me in their lives, and causes more disability than any other medical condi9on worldwide (1,2). A myriad of therapy strategies including drug treatment, injec9on therapies (e.g. epidural cor9costeroid injec9ons, local injec9ons), back exercises, acupuncture, behavioural therapy, massage, biofeedback, and TENS have been described. Electrical muscle s9mula9on (EMS) for management of chronic non-specific low back pain has yet not been properly studied. EMS leads to muscle contrac9on by ac9va9on of myelinated motor neurons before ac9va9on of pain fibres and so differs from TENS. Studies demonstrated that EMS improves lumbar spine func9on significantly in a low back pain popula9on, improves back pain/disability scores and func9onal capacity, quality of life and muscle strength (3). It has been shown (4) that hot treatment reduces pain by vasodilata9on effect and moves reflex arcs that inhibit pain by means of heat receptors. There are few secondary effects when applied regularly. A combina9on of heat therapy and medium frequency EMS may provide addi9on benefit for pa9ents with chronic non-specific low back pain. Our hypothesis was that electric muscle s9mula9on in combina9on with heat could provide beMer pain relief and improvement of subjec9ve and objec9ve data compared to standard treatment without electrotherapy. Par,cipants Adult (>18 years) pa9ents with a medical diagnosis of nonspecific low back pain for > 6 months with a pain intensity of NRS ≥ 4/10 were enrolled. Pa9ents with planned spinal surgery or previous spinal surgery less than 12 month ago, spinal disorders like e.g. tumors, fractures or disk hernia9on with nerve compression with neurological disorders and actual or previous treatment with electrical s9mula9on, including TENS were excluded. In addi9on, pa9ents with concomitant illnesses (e.g. cardiopulmonary, inflammatory, malignancy, osteoporosis, epilepsy or neurological, psychiatric, rheumatologic disorders) or cardiac demand pacemakers, defibrillators, spinal s9mulators or other implanted electronic devices, or with a history of alcohol abuse, substance abuse, or substance dependence were not eligible. Pregnant pa9ents, pa9ents who become pregnant during the study, pa9ents who were not able to read and speak German or pa9ents with pension process were also excluded. S,maWell In this clinical trial, a S9maWell 120 MTRS was used. This system administers a dynamic, wavelike s9mula9on, via 12 sequen9ally opera9ng channels. Different effects can be achieved depending on the frequency used. In addi9on, the s9mula9on maMress with integrated electrodes heats up to 40°C and further integrates heat therapy effects. Study design Between March 2015 and January 2017, we conducted a 6 week randomized, double-blind, stra9fied, placebo controlled clinical trial, comparing two different forms of mul9dimensional dynamic deep wave therapy with placebo treatment with a follow-up 12 weeks ajer randomiza9on. The local Ethics commiMee of Carinthia approved the study protocol and informed consent (protocol number A15/14). The study design included a screening day (baseline evalua9on before randomiza9on); a double-blind, placebocontrolled, randomized, stra9fied treatment phase (18 treatments in 6 weeks; 3 days a week); and a 12-week follow-up. Electrical s9mula9on was discon9nued ajer the 18th treatment. Ajer randomiza9on in one of 4 groups, pa9ents get either one of the mul9dimensional dynamic deep wave therapy programs in combina9on with heat (40°C) (Group A and B), a sham electrotherapy with reducing electrical current output and reducing heat (Group C, placebo group), or standard treatment without electrotherapy (Group D, control group). Results In summary 100 pa9ents, from 217 pa9ent screened, were recruited. Most of the pa9ents (60%) successfully completed the trial. The most common causes of withdrawal were lack of efficacy (11%), increasing back pain during and ajer treatment (9%), protocol viola9ons (3%), headache (1%), recogni9on of placebo treatment (1%), skin irrita9on (1%), and AEs (1% - increasing pain ajer improper use of dynamometer). 14% discon9nued because they were randomized to the control group. Discon9nua9on rates were 5 in Group A (20%), 7 in group B (26.9%), 16 in group C (64%), and 12 in group D (50%). Sta9s9cal analysis showed that pa9ents in group C and D discon9nue more likely (p = 0.005) than pa9ents in groups A and B. Demographic data were similar for the 100 pa9ents who were randomized. Pa9ent demographic characteris9cs were representa9ve of a LBP popula9on. During and ajer treatment negligible side effects e.g. skin irrita9ons were present and EMS was shown to be safe. Primary endpoint Our primary outcome was a change from baseline at 18 days in low back pain pain-intensity score (NRS). Actual pain-intensity scores showed no sta9s9cal difference between the 4 groups before treatment. Mean actual pain intensity score at baseline was 5.7 (SD 0.9). Ajer 18 treatments mean actual average pain-intensity score was 2.6 (SD 2.1); in follow-up, mean actual average pain-intensity score was 3.8 (SD 2.4). Ajer 18 treatments there was a sta9s9cal significant pain reduc9on in group A (p = 0.000), which was also shown for follow-up (p = 0.001). A significant pain reduc9on (p = 0.000) ajer 18 treatments and in follow-up (p = 0.001) was also shown for the treatment group B. Also a placebo effect for group C (p = 0.006) has been shown ajer 18 treatments, but not in follow-up (p = 0.302). There was no significant change from baseline in the control group D. Group comparison NRS: There was no sta9s9cal difference between Group A and B (p = 0.061). Sta9s9cal analysis showed that group A had a significantly (p = 0.000) greater pain reduc9on than the control group D ajer the last treatment. Treatment group B had a sta9s9cal significant (p = 0.029) pain reduc9on compared to group C and group D (p = 0.000). Also a placebo effect (group C significantly greater pain reduc9on compared to the control group D (p = 0.004) has been shown. Conclusion A reduc9on of 3 points for treatment group A in mean actual pain (5.7 to 2.4) and 4 points for treatment group B (5.5 to 1.4) on the 11-point numerical ra9ng scale is highly clinically relevant, as is the sta9s9cal significant persistent effect. In conclusion, mul9dimensional dynamic deep wave therapy is a very effec9ve and safe method for trea9ng chronic low back pain. 0 1 2 3 4 5 6 NRS group A group B group C group D References 1. Chou R. Low back pain (chronic). BMJ Clin Evid. 2010; 2010: 1116. 2. Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: es9mates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. 3. Durmus D, Akyol Y, Alayli G, Tander B, Zahiroglu Y, Canturk F. Effects of electrical s9mula9on program on trunk muscle strength, func9onal capacity, quality of life, and depression in the pa9ents with low back pain: a randomized controlled trial. Rheumatol Int. 2009 Jun;29(8):947-54. 4. Demir Y. Non-Pharmacological Therapies in Pain Management. Pain Management - Current Issues and Opinions, Dr. Gabor Racz (Ed.), 2012. InTech, DOI: 10.5772/30050. stefan.neuwersch [at] kabeg.at

[1] Neuwersch S., Köstenberger ,M. u.a.: ZISOP (2017) – Zentrum für Interdisziplinäre Schmerztherapie und Palliativmedizin Klinikum Klagenfurt am Wörthersee Efficacy of multidimensional dynamic deep wave therapy in patients with chronic non-specific low back pain: a randomized, double-blind, stratfied, placebo controlled clinical trial