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NCT Number: NCT06976580

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

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.

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Key information

Conditions

Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain score

    Time frame: immediately after the local injection

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

Secondary outcomes

  1. unpleasantness score

    Time frame: 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.

  2. behavior pain score

    Time frame: 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.

  3. soreness around the injection site

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

hee jung kim, MD

CONTACT

[email protected]

82-2-2227-3556

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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