Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials

Biomedicines, 2023 · DOI: 10.3390/biomedicines11071931 · Published: July 7, 2023

Urology Neurology Research Methodology & Design

Simple Explanation

This study aimed to develop a sham protocol for transcutaneous tibial nerve stimulation (TTNS) to be used in randomized controlled trials (RCTs). The goal was to find a sham stimulation method that maintains blinding in patients while avoiding meaningful stimulation of the tibial nerve. The researchers tested different electrode positions and sizes to determine the optimal sham configuration based on visible motor responses.

Study Duration

Not specified

Participants

16 healthy volunteers and 1 SCI patient

Evidence Level

Not specified

Key Findings

1
The 5th metatarsal position with 3.2 cm electrodes was found to be the most suitable sham configuration, achieving a 100% motor response rate.
2
Sensory thresholds were present for all sham configurations, with the highest thresholds observed at the plantar calcaneus.
3
Compared to verum TTNS, sham configurations generally had higher sensory and motor thresholds, with perceived pain being higher only at the lateral malleolus.

Research Summary

This study developed an optimal sham configuration for transcutaneous tibial nerve stimulation (TTNS) to be used in randomized controlled trials (RCTs). The researchers tested three potential electrode positions (lateral malleolus, 5th metatarsal, plantar calcaneus) and two electrode sizes (2.5 cm, 3.2 cm) to determine the best sham setup based on motor response. The 5th metatarsal position with 3.2 cm electrodes proved to be the most suitable sham configuration, demonstrating a 100% motor response rate and minimal perceived pain.

Practical Implications

Clinical Trial Design

The developed sham protocol can be implemented in future RCTs to investigate the effectiveness of TTNS while maintaining blinding and controlling for non-specific treatment effects.

Standardized Procedures

Using a four-electrode setup with the optimized sham configuration allows for standardized procedures and instructions, minimizing the ability of patients to guess their group allocation.

Neuro-Urology Research

The findings contribute to the understanding of neuromodulation-induced effects and can be further researched and implemented in future studies to increase knowledge in the field of neuro-urology.

Study Limitations

1
The study did not assess any blinding information regarding verum and sham stimulation.
2
Active sham stimulation at the 5th metatarsal position may induce some clinical improvements, compromising the treatment gap between the verum and sham groups.
3
The results were derived from healthy subjects that were younger compared to the envisaged patient cohorts, and motor response rates may differ in older or neurologically impaired individuals.

Your Feedback

Was this summary helpful?

Back to Urology