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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Pain score [Срок оценки: immediately after the local injection]

Вторичные конечные точки (3)

• unpleasantness score [Срок оценки: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.]
• behavior pain score [Срок оценки: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.]
• soreness around the injection site [Срок оценки: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06976580 · 4-2025-0207

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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