Status:
NOT_YET_RECRUITING
Effect of Skin Stretching on Pain Reduction During Local Anesthetic Injections: A Randomized Clinical Study
Lead Sponsor:
Yonsei University
Conditions:
Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the potential analgesic effect of skin stretching during local anesthetic injection in patients with chronic lumbar pain and bilateral lower extremity radic...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06976580
Start Date
May 1 2025
End Date
December 31 2025
Last Update
May 16 2025
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