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Search / Trial NCT06976580

Effect of Skin Stretching on Pain Reduction During Local Anesthetic Injections: A Randomized Clinical Study

Launched by YONSEI UNIVERSITY · May 8, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Skin Stretching Local Anesthetic Injection Pain Lumbar Spinal Stenosis

ClinConnect Summary

This clinical trial is investigating whether stretching the skin during local anesthetic injections can help reduce pain for patients suffering from chronic low back pain and leg pain due to nerve issues. The researchers believe that stretching the skin might make the injection less painful by helping the anesthetic spread out more easily in the tissue. They will compare this skin stretching technique with the standard injection method to see if it makes a difference in how much pain patients feel during the procedure.

To participate in this study, you need to be at least 19 years old and have had ongoing low back pain for more than three months, along with pain in both legs that affects your daily activities. You should also have a certain level of pain, rated at 5 out of 10 or higher on a pain scale. However, some individuals may not be eligible, such as those who have had recent surgeries on their back or certain medical conditions. If you join the trial, you will receive either the skin-stretching technique or the standard injection method and help researchers learn more about how to improve pain management for people like you.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults aged 19 years or older with chronic low back pain lasting for more than 3 months, accompanied by bilateral lower extremity radiculopathy, who require Selective Transforaminal Epidural Block (STEB).
  • Patients with a Numerical Rating Scale (NRS) score of 5/10 or higher, with pain that affects daily life activities.
  • Exclusion Criteria:
  • Patients whose pain is influenced by mechanisms other than radiculopathy, such as peripheral neuropathy or myelopathy.
  • Patients with a history of lumbar surgery within the last 6 months, or spinal injection treatment within the last 3 months.
  • Patients with a history of allergy to local anesthetics, steroids, or contrast agents, or those at increased bleeding risk due to anticoagulant use (INR \> 1.2).
  • Patients with localized infections, sepsis, uncontrolled diabetes, or hypertension.
  • Patients who are unable to consent or cooperate with the study procedures (e.g., cognitive impairment, severe mental illness).

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported