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Adding a synchronised light signal to Transcutaneous Electrical Nerve Stimulation (TENS) for foot and leg pain in adults with diabetes-related nerve damage: a pilot study
Feasibility, tolerability and preliminary effects of Transcutaneous Electrical Nerve Stimulation (TENS) with synchronised visual feedback compared with TENS alone in adults with painful diabetic peripheral neuropathy of the foot and lower leg: a randomised parallel-group pilot trial
- Sponsor
- Western Sydney University
- Enrolment
- 40 planned
- Conditions
- Painful diabetic peripheral neuropathy; Neuropathic pain of the foot and lower leg; Diabetes mellitus (type 1 or type 2); Painful diabetic peripheral neuropathy Neuropathic pain of the foot and lower leg Diabetes mellitus (type 1 or type 2); Neurological - Other neurological disorders; Metabolic and Endocrine - Diabetes; Anaesthesiology - Pain management
- Interventions
- Control; it is individually titrated for each participant to a clearly perceptible, comfortable sensory level, below the pain threshold, and the value used is recorded for each participant
- Ages
- adults, older adults
- Registry
- ACTRN12626001150336
Full record on ANZCTRSource: WHO ICTRP, processed 21 September 2026
Primary outcomes
- Change in neuropathic pain symptom severity, measured as NPSI total intensity score. This is a composite outcome: the total score out of 100 is derived by summing the five NPSI subscores (burning superficial spontaneous pain; pressing deep spontaneous pain; paroxysmal pain; evoked pain; paraesthesia
- Change in self-reported pain intensity across the plantar surface of the feet. [Study-specific foot-grid pain mapping, in which participants record a pain rating from 0 (no pain) to 10 (worst pain imaginable) for each demarcated region of the left and right plantar foot diagram. Pain intensity is de
- Change in self-reported pain distribution across the plantar surface of the feet. [Study-specific foot-grid pain mapping, using the same left and right plantar foot diagram. Pain distribution is derived as the number of demarcated regions with a rating greater than zero, reported for each foot and i
History
Started
Last registry update
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