The Palliative Effect of TENS-WAA on 'Capsaicin/Heat' Induced Acute Lower Back Pain: a Self-controlled Clinical Study

Launched by XIAONAN HUANG · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new pain relief method for acute lower back pain using a device called Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory (TENS-WAA). The study aims to determine if this device can effectively reduce pain caused by a model that simulates acute back pain using capsaicin, a substance derived from chili peppers that activates pain receptors in the body. The trial will measure how well TENS-WAA works by looking at changes in blood flow in the brain areas that process pain and by asking participants to rate their pain levels.

To participate in this trial, individuals must be healthy adult males aged 18 to 44, who have no recent pain and are not on any medications that could affect their pain perception. Importantly, those with serious health issues, a history of spinal surgery, or certain allergies will not be eligible. Participants can expect to wear the TENS-WAA device on their wrist or ankle during the study, which is designed to be safe and easy to use. This trial is still in the planning stages and is not yet recruiting participants.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy adult males between the ages of 18-44 years;
• • The dominant hand is the right hand;
• • No persistent pain in the last month;
• • No acute pain in the last week;
• • Good health with no medical condition for which he/she is receiving treatment;
• • Subjects agreed to participate in this trial and signed an informed consent form.
• Exclusion Criteria:
• • With malignant tumours and serious heart, liver and kidney diseases;
• • Those with skin breakage at the site of capsaicin application;
• • Those with a history of lumbar spine surgery, spinal fracture, rheumatic disease, cancer, pacemaker, or congenital anomalies of the spine;
• • Any other medical condition that may affect pain perception, including neurological and psychiatric disorders;
• • Taking sedative and sleep-aiding drugs within one week;
• • Those who are allergic to capsaicin;
• • Currently participating in another clinical trial concerning lower back pain or pain.