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The Effectiveness of 5% hypertonic saline adjuvant to lumbosacral transforaminal epidural block in patients with lumbosacral radicular pain screened for neuropathic pain using DN4 (Douler Neuropathique 4) questionnaire: a randomized controlled study

The Effectiveness of 5% hypertonic saline adjuvant to lumbosacral transforaminal epidural block in patients with lumbosacral radicular pain screened for neuropathic pain using DN4 (Douler Neuropathique 4) questionnaire: a randomized controlled study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0006033
Enrollment
100
Registered
2021-03-26
Start date
2021-04-23
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : After obtaining informed consent, the patients condition is evaluated before the procedure, and the site lumbosacral spine to be performed is marked. After applying general monitor

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with chronic lumbosacral unilateral radiating pain over 3 months 2) Patients with symptom-related unilateral 1-2 level lesions of the lumbosacral spine in radiologic examination (CT or MRI) 3) Patients screened for neuropathic pain by obtaining 4 points or more in DN4 questionnaire 4) Patients whose symptoms have not improved even after conservative treatment for more than 3 months 5) Patients with pain intensity of NRS 4 or higher 6) 20 = age <80 7) Patients who voluntarily agreed in writing to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1) Patients in acute phase with pain period less than 3 months 2) Patients whose pain intensity is less than 4 points or 10 points in NRS 3) When the axial pain is more severe than the radiating pain 4) Patients with progressive motor weakness or neurological findings 5) Those who are contraindicated in nerve block procedure, such as coagulopathy or infection 6) Patients with uncontrolled medical or psychiatric problems 7) Patients with side effects from local anesthetics, steroids, or contrast agents 8) Pregnant or lactating patients 9) Patients diagnosed with cancer and undergoing treatment 10) Patients with a history of surgery on the cervical spine 11) If the patient does not agree to participate in the study

Design outcomes

Primary

MeasureTime frame
NRS (Numerical rating scale, 0 = no pain, 10 = unbearable pain)

Secondary

MeasureTime frame
NRS (Numerical rating scale, 0 = no pain, 10 = unbearable pain);ODI(0 – 50; 0 = no disability, 50 = complete disability);MQS (Medication quantification scale);PHQ-9 (patient health questionnaire-9);GPE (Global perceived effect, 1-7);Responder rate (0 – 100% of patients)

Countries

Korea, Republic of

Contacts

Public ContactHyun-Jung Kwon

Asan Medical Center

hyunjung.kwon88@gmail.com+82-2-3010-0059

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026