Lumbar Spinal Stenosis With Bilateral Lower Extremity RadiculopathyNCT06976580
Effect of Skin Stretching on Pain Reduction During Local Anesthetic Injections: A Randomized Clinical Study
A study testing conventional local anesthetic injection and skin stetching technique for local anesthetic injection in people with Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy
- What is being tested?
- conventional local anesthetic injection and skin stetching technique for local anesthetic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 May 2025to 26 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine
Seoul, Seodamun-gu
About this 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.
- Being tested
- conventional local anesthetic injection, skin stetching technique for local anesthetic injection
- Keywords
- skin stretching, local anesthetic injection pain, lumbar spinal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional local anesthetic injectionProcedure or surgery
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 injectionProcedure or surgery
Skin stretching techinique will be applied to the local anesthetic injection site by stretching the skin around the needle entry point.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | conventional local anesthetic group Receives: Procedure: conventional local anesthetic injection |
| skin stretching group | Active comparator | skin stretching group for anesthetic local injection Receives: Procedure: skin stetching technique for local anesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
A comparison of pain score between control (conventional local anesthetic method) and skin stretching group using NRS.
Measured: immediately after the local injection
Secondary outcomes (3)
unpleasantness score
A comparison of unplesantness score(NRS), and skin stretching group.
Measured: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.
behavior pain score
pain behavior using Pain Assessment in Advanced Dementia (PAINAD) scale, and skin stretching group.
Measured: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.
soreness around the injection site
soreness around the injection site between control (conventional local anesthetic method) and skin stretching group using NRS (numeral rating scale).
Measured: immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start7 May 2025
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal Stenosis With Bilateral Lower Extremity RadiculopathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976580
- Sponsor's protocol ID
- 4-2025-0207
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skin Stretching on Pain Reduction During Local Anesthetic Injections: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06976580
- Acronym / sponsor ID
- 4-2025-0207
- Keywords
- skin stretching, local anesthetic injection pain, lumbar spinal stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Procedure: conventional local anesthetic injectionconventional local anesthetic group |
| skin stretching group | Active comparator | Procedure: skin stetching technique for local anesthetic injectionskin stretching group for anesthetic local injection |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional local anesthetic injectionA 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 or surgery | control group |
| skin stetching technique for local anesthetic injectionSkin stretching techinique will be applied to the local anesthetic injection site by stretching the skin around the needle entry point. | Procedure or surgery | skin stretching group |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional local anesthetic injection and skin stetching technique for local anesthetic injection in people with Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: immediately after the local injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.