CompletedNot Applicable

A Comparison Study Between Contrast Spread and Loss of Resistance Techniques

United States45 participantsStarted 2019-08-19

Plain-language summary

Early epidural space identification is critical to the efficacy and safety of cervical epidural steroid injections (CESI) \[1\]. Currently, the accepted method for epidural space recognition is the loss of resistance technique (LORT). I perform CESIs with fluoroscopy only \[2\]. I hypothesized that the contrast spread technique (CST) might recognize epidural space concurrently with or sooner than LORT. I also suggested that smaller needles might be employed with CST but not with LORT. To test my hypotheses, I conducted a comparison study.

Who can participate

Age range

18 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: * Clinical and recent MRI findings confirming the diagnosis of cervical radiculitis * Inadequate pain relief with conservative care for more than 3 months * Signed informed consent * The procedure was covered by medical insurance Exclusion Criteria: * Bleeding disorder or anticoagulants therapy * Serious comorbidities such as congestive heart failure * Pregnancy * Uncontrolled diabetes mellitus * Refusal to participate in the study

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

Confirmation of the LOR with epidurally located 18G Tuohy needle by the Epidrum device.

Timeframe: 30 seconds

Confirmation of the LOR with epidurally located 25G Tuohy needle by the Epidrum device.

Timeframe: 30 seconds

Trial details

NCT IDNCT05260294

SponsorYakov Perper, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-08

View on ClinicalTrials.gov More Cervical Radiculopathy trials