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

NCT ID: NCT06976580

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

control group

conventional local anesthetic group

Group Type: EXPERIMENTAL

conventional local anesthetic injection

Intervention Type: 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.

skin stretching group

skin stretching group for anesthetic local injection

Group Type: ACTIVE_COMPARATOR

skin stetching technique for local anesthetic injection

Intervention Type: PROCEDURE

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

Interventions

conventional local anesthetic injection

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.

Intervention Type: PROCEDURE

skin stetching technique for local anesthetic injection

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

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

hee jung kim, MD

Role: CONTACT

HEEJKIM@yuhs.ac

82-2-2227-3556

Other Identifiers

4-2025-0207

Identifier Type: -

Identifier Source: org_study_id