Does it Need to be New to be Novel?

One area of my research for the past 9-years has been studying electrical stimulation and healing of chronic wounds [1-9]. The mention of electrical stimulation as a modality is not new, and too many, not novel (or evidence-based). Electrical stimulation has been used as a modality to decrease pain for over 100 years. It was FDA approved by the United States for increasing blood flow. Numerous papers have been published over the past 50 years on electrical stimulation for its ability to decrease pain, facilitate strength, increase blood flow and heal wounds. This modality is not novel anymore, or is it? I believe looking at 3 main areas can help us become an evidence-based consumer of a modality so it may become novel in your practice.

Research: If we need an objective judge and jury for a modality, we must look at the research. Electrical stimulation or functional electrical stimulation (FES) has shown great clinical utility for strengthening after and ACL repair [10]. Transcutaneous electrical stimulation (TENS) was at one time prescribed to many people with pain. The health care provider and insurance companies found the outcomes for long-term relief of pain poor and TENS decreased in popularity quickly [11]. Electrical stimulation and its application for non-healing wounds have had varied outcomes for wound healing rates. The excitement about this novel modality for wound healing dwindled as clinical outcomes experienced by the clinician did not match the expectation of a good healing rate.

Research that is “not significant”: In order to prevent a Type I error, we have historically set the probability at .05. If a study used electrical stimulation to treat a wound vs. standard care and p>.05, does this immediately indicate that electrical stimulation is not a good modality for wounds? If we found out that P=.08, would this be clinically meaningful? In the same scenario, researchers would want to prevent a type II error (also called power). Power is directly related to sample size and effect size. If the study indicated p=.08, is that still clinically meaningful?

Both Type I and II errors with our modality may still be novel. We may need to increase the sample size (power) or analyze the methods before stating it is not significant.

Being Novel with a modality: If a novel modality is still not achieving the desired outcomes, one may want to look at specific parameters. Target populations, electrical stimulation parameters and electrodes similar to the successful trials? In my past studies differences have been found in blood flow by adding heat plus electrical stimulation, biphasic vs. monophasic waveforms, type of electrode and a novel electrical stimulation device using a whirlpool type current.

Does it need to be new to be novel? In my opinion, the answer is no. Research that changes electrical stimulation parameters may create something very novel with excellent clinical outcomes. Become an evidence-based consumer of research and observe if your clinical outcomes can be improved with a modality that is not novel.

1. Lawson D,Petrofsky JS (2007) A randomized control study on the effect of biphasic electrical stimulation in a warm room on skin blood flow and healing rates in chronic wounds of patients with and without diabetes. Med SciMonit 13: CR258-263.
2. Lawson D, Petrofsky J(2013) The effect of monophasic vs. biphasic current on healing rate and blood flow in people with pressure and neuropathic ulcers. J Acute Care PhysTher 4:26-33.
3. Petrofsky J, Lawson D, Prowse M, Suh HJ (2008) Effects of a 2-, 3- and 4-electrode stimulator design on current dispersion on the surface and into the limb during electrical stimulation in controls and patients with wounds. J Med EngTechnol 32: 485-497.
4. Petrofsky J, Schwab E, Cuneo M(2006)Current distribution under electrodes in relation to stimulation current and skin blood flow: Are modern electrodes really providing the current distribution during stimulation we believe they are? J Med EngTechnol 30:368-381.
5. Petrofsky JS Lawson D, Berk L, Suh H (2010) Enhanced healing of diabetic foot ulcers using local heat and electrical stimulation for 30 min three times per week. J Diabetes 2: 41-46.
6. Petrofsky JS, Lawson D, Suh HJ, Rossi C, Zapata K, et al. (2007) The influence of local versus global heat on the healing of chronic wounds in patients with diabetes. Diabetes TechnolTher 9: 535-544.
7. Petrofsky JS, Schwab E, Lo T, Cuneo M, Lawson D (2007) The thermal effect on the blood flow response to electrical stimulation. Med SciMonit 13: CR498-504.
8. Suh H Petrofsky J, Fish A, Hernandez V, Mendoza E, et al. (2009) A new electrode design to improve outcomes in the treatment of chronic non-healing wounds in diabetes. Diabetes TechnolTher 11: 315-322.
9. Suh H, Petrofsky JS, Lo T(2009) The combined effect of a three-channel electrode delivery system with local heat on the healing of chronic wounds. Diabetes TechnolTher 11:681-688.
10. Imoto AM, Peccin S, Almeida GJM, Saconato H, Atallah ÁN(2011) Effectiveness of electrical stimulation on rehabilitation after ligament and meniscal injuries: a systematic review São Paulo Medical Journal = RevistaPaulista De Medicina 129:414-423.
11. Poitras S, Brosseau L(2008) Evidence-informed management of chronic low back pain with transcutaneous electrical nerve stimulation, interferential current, electrical muscle stimulation, ultrasound, and thermotherapy.Spine J 8:226-233