CompletedNot Applicable

A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections

United States120 participantsStarted 2010-02

Plain-language summary

The purpose of this study is to: * evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections. * evaluate and compare the adverse event profile in all groups.

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: * Patients with history of lumbar surgery of at least 6 months duration in the past * Patients over the 18 years of age * Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration * Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements Exclusion criteria: * Post surgery, central spinal stenosis, and facet joints as sole pain generators * Unstable or heavy opioid use * Uncontrolled psychiatric disorders * Uncontrolled medical illness * Any conditions that could interfere with the interpretation of the outcome assessments * Pregnant or lactating women * Patients with a history or potential for adverse reaction(s) to local anesthetics or steroid.

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

Numeric rating scale (NRS), Oswestry Disability Index (ODI)

Timeframe: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.

Trial details

NCT IDNCT01053273

SponsorPain Management Center of Paducah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

View on ClinicalTrials.gov More Low Back Pain trials