UnknownNot Applicable

Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block

South Korea50 participantsStarted 2016-04

Plain-language summary

This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results in shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy and safety of US-guided LSB, and 3) To verify that US-guided LSB has similar success rates to fluoroscope-guided LSB. 50 patients who are supposed to undergo LSB due to sympathetically maintained pain, satisfy criteria of inclusion and exclusion, and voluntarily sign the informed consent will be enrolled.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who have sympathetically-mediated pain and are supposed to undergo LSB procedure (e.g. pain with asymmetric skin temperature of lower limb in previous thermography, small fiber disorder in previous quantitative sudomotor axon reflex test (QSART), vascular insufficiency in lower extremities, diabetic polyneuropathy, postherpetic neuralgia, complex regional pain syndrome, cancer-related neuropathic pain such as chemotherapy-induced peripheral neuropathy, other lower extremity neuropathies, lower extremity crush injury etc.) * Numeric rating scale (NRS) ≥ 4/10 * Failure of previous conservative treatments, such as physiotherapy, oral medication, or other noninvasive treatment Exclusion Criteria: * Previous lumbar sympathetic neurolysis * Bleeding tendency * Local infection * Allergy to local anesthetics or contrast media * Pregnancy * Severe variation near procedure site-scoliosis, tumor, abdominal aneurysm, etc. * BMI ≥ 30 kg/m2 * Cognitive dysfunction

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in Procedure time (I1)

Timeframe: through the LSB procedure completion (day 0)

Trial details

NCT IDNCT02737527

SponsorSeoul National University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11

Contact for this trial

Jee Youn Moon, MD, PhD

82-10-5299-2036 jymoon0901@gmail.com

View on ClinicalTrials.gov More Complex Regional Pain Syndrome trials