Comparative Study of the Efficacy between Self-controlled Energo-Neuro-Adaptive Regulator and Transcutaneous Electrical Nerve Stimulation for Whiplash Injury
by Jaesung Han, Inbo Han
Department of Neurosurgery, CHA Bundang Medical Center, CHA University, Seongnam, Korea
Objective: Self-Controlled Energo-Neuro-Adaptive Regulator (SCENAR) device was introduced in 2006 as an alternative electrotherapy for pain in Korea. The aim of this study is to investigate the efficacy of SCENAR standing for SCENAR in patients with subacute neck pain following a rear-end collision.
Methods: A randomized and controlled prospective study was conducted on 60 patients with neck pain following rear-end collision between the ages of 20 to 50 years. Written informed consent was obtained and participants were randomly allocated to transcutaneous electrical nerve stimulation (TENS) and SCENAR therapy. The treatment regimen included 20-min treatment sessions for 4 weeks (3 times per week). Therapeutic effects were evaluated at each of the assessment points (0, 4, 8, 12 and 16 weeks) using a visual analogue scale (VAS) pain scores and neck disability index (NDI) scores. Results: Eligible participants (n=70) were recruited between March 2014 and July 2015. Final trial sample (n=60) compromised 32 within the SCENAR group and 28 TENS group. The SCENAR group showed superior pain reduction compared with TENS (SCENAR: initial mean VAS score; 6.3, final mean VAS score; 2.1, TENS: initial mean VAS score; 6.2, final mean VAS score; 3.7). Sixteen week NDI scores showed the disability level of the SCENAR group (9.5) was significantly lower than that of the TENS group (14.3).
Whiplash occurs as the result of acceleration-deceleration mechanism of energy transfer to the neck. It is a symptom com- plex which has no pathological or radiological correlates2,11,13). The most common cause is a motor vehicle accident such as rear-end or side-impact collisions. The most common symptom is neck pain. In addition to neck pain, there may be pain in one or both arms and interscapular area and arm pain. The most common treatment options include physiotherapy, acu-puncture, or a neck collar2,11,13). However, the recovery is often incomplete and 30% to 40% of people who get neck pain fol-lowing motor vehicle accident continue to complain of constant severe pain even after 12 month13,15).
Electrotherapies such as transcutaneous electrical nerve sti- mulation (TENS) are one of popular treatment options for whi- plash patients12). The Self-Controlled Energo-Neuro-Adaptive Regulator (SCENAR; ZAO, OKB RITM, Russia) standing for SCENAR is a hand held, battery powered, electrotherapy de- vice. It was first invented in Russia in mid-80s under space and military research program. The SCENAR device combines Western electrical biofeedback with Eastern energy medicine14). This is the first time that SCENAR therapy is used in the treat-ment of whiplash. The aim of this study was to investigate the short-term efficacy of SCENAR therapy in patients with subacute neck pain after rear-end collision.
Materials & Methods
In the period March 2014 to July 2015 consecutive patients who presented to the spine center at our hospital after a motor vehicle accident were evaluated for recruitment into our study. The study was approved by the Institutional review board of
our institute and informed consent was obtained from all the participants.
Whiplash injury can be categorized into 4 different grades according to clinical symptoms and radiologic findings. Our study included 1, 2 grade of whiplash injury patients, 20 to 50 years of age who had been exposed to a rear-end car colli-sion experienced neck pain for more than 1 month. The fol-lowing patients were excluded from the study: (1) patients aged below 20 or above 50 years; (2) patients with neurologi- cal deficits, whiplash injury grade 3; (3) patients with fractures or dislocation of the cervical spine, loss of consciousness after accident, and injuries other than the whiplash injury. Further- more, we also excluded patients presenting contraindications for the SCENAR therapy, which compromised those having cardiac pacemaker.
Electrodes were applied to the skin overlying the posterior surface of the neck and upper thorax regions. Dosage was set to a level that the participant described as strong but comfor- table. Participants received TENS therapy (100 Hz, 200 sec, 2 mA) according to the schedule (for 20 min, 3 times per week for 4 weeks).
SCENAR device weighs approximately 208.5 g is 180 mm in length and 60 mm width, with an electrical contact at one end and runs off a 4.5 V battery (Fig. 1). The practitioner appl- ies it onto the skin overlying the posterior surface of the neck and upper thorax regions in an identical manner to the TENS therapy. The SCENAR device provides slightly uncom- fort-able but not painful sensation. Participants received SCENAR therapy for 20 min, 3 times per week, for 4 weeks.
The dimensions, application to skin regions, and overall po- tential treatment sensations of each group had similar proper-ties to facilitate a blinded comparison.
Participants scored their average neck pain using a visual analogue scale (VAS) pain scores (0=no pain and 10=worst pain)8). Neck disability was measured by neck disability index (NDI) scores (0=no neck disability and 30=extremely dis-abled)9). VAS pain scores and NDI scores were collected du- ring weeks 4, 8, 12 and 16 of the trial. The administrators were blinded as to which therapy each participant received.
Data analysis was performed using StatsDirect software ver-sion 2.4.4 (StatsDirect Ltd., Altrincham, UK) and GraphPad Prism 4.0 (GraphPad Software, Inc., San Diego, CA, USA). Variableare presented as mean±standard deviation compared using a Student t test for continuous variables and the Chi- square test for categorical variables between SCENAR and TENS groups. Logistic regression analyses were to adjust possi- ble confounders, including age, gender, hypertension and dia- betes mellitus (DM). A p-value of 0.05 was considered to indi- cate statistical significance.
A total of 70 participants were included in the present trial. The clinical characteristics of all the subjects are summarized in Table 1. There was no statistically significant difference for age and gender. Additionally, the prevalence of hypertension and DM did not differ between SCENAR and TENS groups (Table 1). In the TENS group, 7 participants were lost during follow-up compared with 3 in the SCENAR group. No adverse affects were registered in any of intervention groups.
Pain and neck disability scores at each follow-up are shown
Table 1. Baseline characteristics in participants who completed the trial..
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