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

NCT06976580 | Completed DMC

• 1 other identifier: 4-2025-0207
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy

Keywords

skin stretching; local anesthetic injection pain; lumbar spinal stenosis

Outcome Measures

Primary Outcomes (1)

• Pain score

  A comparison of pain score between control (conventional local anesthetic method) and skin stretching group using NRS.

  immediately after the local injection

Secondary Outcomes (3)

• unpleasantness score

  immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.

• behavior pain score

  immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.

• soreness around the injection site

  immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.

Study Arms (2)

control group

EXPERIMENTAL

conventional local anesthetic group

Procedure: conventional local anesthetic injection

skin stretching group

ACTIVE COMPARATOR

skin stretching group for anesthetic local injection

Procedure: skin stetching technique for local anesthetic injection

Interventions

conventional local anesthetic injection PROCEDURE

A conventional infiltration anesthesia will be conducted on the lumbar area of the patient, targeting the epidermis and subcutaneous tissue. A 25G syringe will be used, with the needle angle set between 30° and 45°. 1cc of 1% lidocaine will be injected. The target size of the wheal is 5-10 mm.

control group

skin stetching technique for local anesthetic injection PROCEDURE

Skin stretching techinique will be applied to the local anesthetic injection site by stretching the skin around the needle entry point.

skin stretching group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, Seodamun-gu, South Korea

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 16, 2025
• Study Start: May 7, 2025
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)