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

Not Applicable

Not yet recruiting

• Conditions: Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy

• Registration Number: NCT06976580
• Lead Sponsor: Yonsei University

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 radiculopathy undergoing selective transforaminal nerve block. This research is based on the hypothesis that mechanical skin stretching can reduce injection-related pain by facilitating the dispersion of the anesthetic agent and decreasing tissue resistance. By comparing the skin stretching technique with the conventional method of local anesthetic administration, this study aims to evaluate differences in pain perception, discomfort, and behavioral pain responses. The ultimate goal is to provide evidence for a simple, non-invasive, and effective intervention that can improve patient comfort and enhance the quality of clinical pain management.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-21
• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score	immediately after the local injection	A comparison of pain score between control (conventional local anesthetic method) and skin stretching group using NRS.

Secondary Outcome Measures

Name	Time	Method
unpleasantness score	immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.	A comparison of unplesantness score(NRS), and skin stretching group.
behavior pain score	immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.	pain behavior using Pain Assessment in Advanced Dementia (PAINAD) scale, and skin stretching group.
soreness around the injection site	immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.	soreness around the injection site between control (conventional local anesthetic method) and skin stretching group using NRS (numeral rating scale).