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Effect of TENS on Sensory Parameters in Diabetic Polyneuropathy
Sponsor: Burdur Mehmet Akif Ersoy University
Summary
Diabetic polyneuropathy is a common complication of diabetes that damages the nerves of the feet and legs. Besides causing pain, it gradually reduces the ability to feel light touch on the sole of the foot. This loss of protective sensation is important because it removes the warning signal that normally prevents unnoticed injuries, which can lead to foot ulcers. Transcutaneous electrical nerve stimulation (TENS) is a non-drug treatment that delivers mild electrical currents through the skin using surface electrodes. It is inexpensive, widely available, and generally well tolerated. Most previous studies of TENS in diabetic polyneuropathy have looked at whether it relieves pain. Far less is known about whether it affects touch sensation, and whether the frequency of the stimulation matters. This study compares three groups of patients with long-standing diabetic polyneuropathy. One group receives high-frequency TENS (100 Hz), one receives low-frequency TENS (5 Hz), and one receives sham stimulation at an intensity too low to have a treatment effect. Treatment is given five days a week for eight weeks, with electrodes placed on the calf and the sole of the foot. The main measure is the lightest touch a participant can feel on the big toe, tested with Semmes-Weinstein monofilaments before and after the eight-week period. Additional measures include electrical and pressure pain thresholds and questionnaires on pain, mood, and quality of life. Participants and the researchers performing the assessments do not know which group each participant is in.
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation on Sensory Parameters in Patients With Diabetic Polyneuropathy: A Randomized, Double-Blind, Sham-Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2021-09-06
Completion Date
2021-11-01
Last Updated
2026-09-08
Healthy Volunteers
No
Interventions
High-Frequency TENS
Transcutaneous electrical nerve stimulation delivered with a dual-channel PRIMERA TENS/NMES stimulator (DJO, LLC, USA) using standard 2-inch self-adhesive electrodes, one placed on the calf and one on the plantar surface of the foot. Stimulation was delivered at 100 Hz with a pulse width of 200 microseconds for 30 minutes per session, using a zero-direct-current, asymmetric biphasic rectangular waveform. Intensity was individually adjusted to each participant's sensory tolerance. Sessions were delivered five days per week for eight weeks.
Low-Frequency TENS
Transcutaneous electrical nerve stimulation delivered with the same device, electrode type, and electrode placement as the high-frequency arm. Stimulation was delivered at 5 Hz with a pulse width of 175 microseconds for 15 minutes per session, using a zero-direct-current, asymmetric biphasic rectangular waveform. Intensity was individually adjusted to each participant's sensory tolerance. Sessions were delivered five days per week for eight weeks.
Sham TENS
Sham stimulation delivered with the same device, electrode type, and electrode placement as the active arms, at a sub-therapeutic intensity (approximately 2-3 mA) insufficient to produce a physiological effect. All other aspects of the procedure were identical to the low-frequency arm, including session duration and schedule. Sessions were delivered five days per week for eight weeks.
Locations (1)
Akdeniz University City:
Antalya, Turkey (Türkiye)