Skip to main content
. 2024 Mar 19;5:1321148. doi: 10.3389/fpain.2024.1321148

Table 1.

FDA cleared indications, technology and parameters, and mechanism of action for transcutaneous electrical nerve stimulation (TENS) and H-Wave®.

Device name FDA cleared indications Technology and parameters Mechanism of action
Transcutaneous electrical nerve stimulation (TENS)
  • Symptomatic relief and management of chronic, intractable pain

  • Adjunctive treatment for post-surgical and post-trauma acute pain

  • Rectangular waveform

  • High frequency (50–100 Hz), low intensity, short pulse duration (50–200 μs)

  • Acupuncture-like TENS (uncommonly used), low-frequency (2–4 Hz), high intensity, longer pulse duration (100–400 μs)

  • Pulse amplitude/intensity adjustable from 0 to 100 mA (current) peak into 500ohm load (0–50 V, voltage) into each channel

Pre-clinical TENS studies suggest multifactorial effects:
  • Peripheral mechanism triggers peripheral opioidergic pathways

  • Spinal effect attributed to “gate-control theory” reduced inflammation-induced dorsal horn neuron sensitization, altered levels of neurotransmitters including gamma-aminobutyric acid and glycine, and modulation of glial cells

  • Endogenous analgesia mediated by descending inhibitory activity transmitted via midbrain periaqueductal grey and rostral ventral medulla

H-Wave®
  • Chronic pain, post-surgical pain, acute pain, temporary pain

  • Relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, maintaining or increasing range of motion

  • Anesthesia in general dentistry, crown, composite and amalgam preparations, periodontal scaling and root planning

  • Muscle spasms associated with temporomandibular joint (TMJ), and muscle re-education, as in regaining joint control in TMJ

  • Proprietary exponentially decaying biphasic waveform

  • Dual-frequency (2 channels), ultra-low (2 Hz), high (60 Hz), or combined; ultra-long pulse duration (5,000 μs)

  • At 1,000-ohm load, delivers 0–35 mA current and 0–35 V voltage

Pre-clinical H-Wave® studies indicate that the low frequency (2 Hz) component causes several cumulative physiological effects:
  • Stimulation of voluntary contraction of smaller, slow twitch skeletal muscle red fibers, resulting in non-fatiguing low-tension contractions

  • Increased blood flow via vasodilation mediated by nitric oxide, skeletal muscle fiber stimulation, and angiogenesis/neovascularization

  • Increased rhythmic lymphatic vessel drainage through stimulation of voluntary smooth muscle fiber contractions, causing fluid and protein waste removal from areas of inflammation

The high frequency (60 Hz) component results in significant prolonged analgesia, through cumulative, repressive effects on nerve action potentials via sodium channel pump deactivation