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Not yet recruiting NCT06976580

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

No phase Interventional Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: conventional local anesthetic injection, skin stetching technique for local anesthetic injection.
Who it may be relevant to
Registry conditions: Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure 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.
  • 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.

Primary outcome measures

  • Pain score [Time frame: immediately after the local injection]
Secondary outcome measures (3)
  • unpleasantness score [Time frame: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.]
  • behavior pain score [Time frame: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.]
  • soreness around the injection site [Time frame: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06976580 · 4-2025-0207

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗