Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy
Conditions
Keywords
skin stretching, local anesthetic injection pain, lumbar spinal stenosis
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.
Interventions
PROCEDUREconventional 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.
PROCEDUREskin 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | immediately after the local injection | A comparison of pain score between control (conventional local anesthetic method) and skin stretching group using NRS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| unpleasantness score | 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. |
| behavior pain score | 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. |
| soreness around the injection site | 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). |
Contacts
Primary Contacthee jung kim, MD
Outcome results
None listed