Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Xiaonan Huang

Conditions:

Acute Low Back Pain

Eligibility:

MALE

18-44 years

Phase:

NA

Brief Summary

Acute lower back pain is a common condition that occurs in all age groups, and most people will experience acute lower back pain at least once in their lives. The use of pharmacological analgesic inte...

Detailed Description

Content of the study Phase 1 trial: subjects were randomly divided into Left1 group (n=15) and Right1 group (n=15), subjects in the Left1 group were intervened in the left lower ankle after capsaicin/...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 5 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06944665

Start Date

May 5 2025

End Date

January 31 2026

Last Update

April 25 2025

Active Locations (1)

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1

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China, 200433