Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial)BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5160 (Published 02 September 2013) Cite this as: BMJ 2013;347:f5160
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It’s Time to Regulate the Use of Whole-body Electrical Stimulation
Authors and affiliations:
Stephen D H Malnick,1 director, Yael Band,1 resident, Pavel Alin,1 senior physician, Nicola A Maffiuletti,2 director
1 Department of Internal Medicine, Kaplan Medical Center, Rehovot, Israel
2 Human Performance Lab, Schulthess Clinic, Zurich, Switzerland
Transcutaneous electrical stimulation (ES) of human nerves and muscles has long been used as a nonpharmacological treatment for pain relief  and/or as a rehabilitation modality to either preserve or restore skeletal muscle mass and function during and after a period of disuse due to injury, surgery or illness . More recently, whole-body ES has emerged as an alternative form of physical exercise for improving fitness and health among healthy people. Despite limited scientific evidence on the safety and effectiveness of this form of exercise, several ES company-sponsored fitness centers have recently been opened in different countries worldwide , making this technology easily accessible to the general population.
On August 4, 2015, a 20-year-old man presented to our hospital with severe muscle pain shortly after one session of gym-based whole-body ES exercise supervised by a fitness professional. Urine and blood testing revealed myoglobinuria, leukocytosis and elevated levels of creatine kinase (129,250 IU/L) and myoglobin (15,450 ng/mL). A diagnosis of rhabdomyolysis was made and he was hospitalized and treated with 11 liters of intravenous 0.9% saline for 5 days. As his condition improved clinically, there was a concomitant decline in creatine kinase levels and a progressive regression of symptoms, similarly to the other cases of whole-body ES-induced rhabdomyolysis described in the literature [4, 5].
On December 3, 2015, an Israeli public television channel presented the potential dangers of whole-body ES in a documentary, in which two of us (SDHM and NAM) were interviewed . We basically warned against inappropriate use of whole-body ES (even if gym-based), discussed the increased risk of rhabdomyolysis and recommended a more active involvement of the regulatory authorities.
During the first few days following the documentary, several other individuals complaining of aching muscles after exerting themselves with whole-body ES contacted our hospital for advice. Two of them were diagnosed with rhabdomyolysis and were hospitalized and treated with intravenous saline for several days. We suspect that the true number of people injured by this form of exercise may be much higher but they are undiagnosed.
On January 11, 2016, the Health Ministry of Israel issued an official warning about ES safety, and recommended that ES devices must not be used in gyms and without medical supervision .
Regulatory authorities, clinicians and users need a greater understanding and awareness of the risk of ES-induced rhabdomyolysis, heightened ability to recognize this condition, and more diligent strategies to prevent this potentially-harmful effect. The Health Ministry of Israel has played a key in role in this regard, and this should serve as an example to other regulatory authorities worldwide.
1. Chesterton LS, Lewis AM, Sim J, et al. Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial). BMJ 2013;347:f5160.
2. Gibson JN, Smith K, Rennie MJ. Prevention of disuse muscle atrophy by means of electrical stimulation: maintenance of protein synthesis. Lancet 1988;2:767-770.
3. Herrero AJ, Martin J, Benito PJ, Gonzalo-Martinez I, Chulvi-Medrano I, Garcia-Lopez D. National Strength and Conditioning Association-Spain position stand. Whole-body electromyostimulation training [Posicionamiento de la National Strength and Conditioning Association-Spain. Entrenamiento con electroestimulación de cuerpo completo]. [Article in Spanish.]. Revista Andaluza de Medicina del Deporte 2015;8:155-62.
4. Kastner A, Braun M, Meyer T. Two cases of rhabdomyolysis after training with electromyostimulation by 2 young male professional soccer players. Clin J Sports Med. 2015;25:e71-3.
5. Finsterer J, Stollberger C. Severe rhabdomyolysis after MIHA-bodytech® electrostimulation with previous mild hyper-CK-emia and noncompaction. Int J Cardiol. 2015;180:100-102.
6. Television documentary on the potential dangers of whole-body electrical stimulation. Channel 10. December 3, 2015: http://lifestyle.nana10.co.il/Article/?ArticleID=1161777. Accessed March 14, 2016.
7. Warning to the public of the health risks involved in the use of EMS devices in gyms and privately. Israel Health Ministry. January 11, 2016: http://www.health.gov.il/English/News_and_Events/Spokespersons_Messages/.... Accessed March 14, 2016.
Patient consent obtained.
Competing interests: No competing interests
Re: Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial)
Transcutaneous electrical nerve stimulation (TENS) which is a noninvasive treatment, is primarily used to reduce pain. One randomised controlled trial showed TENS could relieve pain for patients with tennis elbow compared with sham TENS . And previous meta-analysis also indicated that TENS was effective for the management of the patients with chronic musculoskeletal pain . However, Chesterton and colleagues’ multicentre randomised clinical trial did not support the use of TENS for tennis elbow . Therefore, we conducted a meta-analysis (Registration: PROSPERO CRD42013005682) to assess the effects of TENS for tennis elbow.
Relevant randomised clinical trials were identified by electronically searching the following data sources (up to September, 2013): Medline, Embase, Web of Science, the Cochrane Library, PEDro, CINAHL, China Biology Medicine disc. Keywords related to epicondylitis such as ‘epicondylitis’, ‘tennis elbow’, ‘physical therapy’, ‘electrotherapy’, and ‘TENS’ were included. We included patients with tennis elbow in the systematic review. And we only considered these trials that compared a treatment group, which received TENS, and a control group, which performed sham TENS, other interventions or no intervention. Primary outcome measure is pain intensity. The Physiotherapy Evidence Database scale  was used to assess the risk of bias for included trails in the systematic review.
Two randomised controlled trials [1, 3] of 301 patients met the inclusion criteria for the meta-analysis. According to Physiotherapy Evidence Database scale, one trail 1 including 60 patients is low quality (PEDro score=3), another trail 3 including 241 patients is high quality (PEDro score=8). The pooling revealed that TENS was not superior to control group for pain relief [SMD (95% CI) = -0.09 (-0.37, 0.19), p=0.55]. In all subgroups, there were no significant differences between TENS and control group at the end of the intervention [SMD (95% CI) = -0.37 (-1.40, 0.66), p=0.48], intermediate term [SMD (95% CI) = 0.10 (-0.15, 0.36), p=0.42] and long term [SMD (95% CI) = -0.11 (-0.36, 0.15), p=0.41]. See figure 1.
The current evidence indicates TENS did not provide additional benefit for relieving pain compared to control group. However, the number of included studies and the sample size of subjects in this meta-analysis were small. Therefore, some large-scale randomised clinical trials are needed. To evaluate how long any improvement intervention may last based on TENS, we need more trails for follow-up sessions with longer durations in tennis elbow. In addition, there are different frequencies in use for TENS, which could lead to different results in tennis elbow. Hence, it is necessary to perform a meta-analysis of different frequencies of TENS to determine the optimal intervention approach in tennis elbow.
Xue-Qiang Wang, Pei-Jie Chen*
Key Laboratory of Exercise and Health Sciences, Ministry of Education, Shanghai University of Sport, Shanghai, China
Correspondence to: Pei-Jie Chen, firstname.lastname@example.org.
1. Weng C-S, Shu S-H, Chen C-C, Tsai Y-S, Hu W-C, Chang Y-H. The evaluation of two modulated frequency modes of acupuncture-like TENS on the treatment of tennis elbow pain. Applications Basis & Communications 2005;17:236-42.
2. Johnson M, Martinson M. Efficacy of electrical nerve stimulation for chronic musculoskeletal pain: a meta-analysis of randomized controlled trials. Pain 2007;130:157-65.
3. Chesterton LS, Lewis AM, Sim J, Mallen CD, Mason EE, Hay EM, van der Windt DA. Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial). BMJ 2013; 347:f5160.
4. Pinto RZ, Maher CG, Ferreira ML, Hancock M, Oliveira VC, McLachlan AJ, Koes B, Ferreira PH. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Ann Intern Med. 2012;157:865-77.
Competing interests: No competing interests