Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
CompletedEarly phase 1NCT00370799
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids. To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. To assess improvements among patients and compare steroid groups with each other and local anesthetic group. To evaluate and compare the adverse event profile in all patients
Study details
- Official title
- A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome
- Conditions
- Interventions
- Drug: Caudal epidural injection
- Drug: Caudal Epidural Injection with generic Celestone
- Drug: Caudal Epidural Injection with Celestone
- Drug: Caudal Epidural Injection with DepoMedrol
- Sponsor
- Pain Management Center of Paducah
- Start date
- 2007-01
- Primary completion
- 2009-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * At least 18 years of age * History of chronic, function-limiting low back pain of at least 6 months duration * Able to give voluntary, written informed consent to participate, * Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up * No recent surgical procedures within last three months Exclusion Criteria: * Cauda Equina symptoms and/or compressive radiculopathy * Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine * Uncontrolled major Depression or uncontrolled psychiatric disorder * Uncontrolled or acute medical illnesses * Chronic severe conditions that could interfere with outcome assessments * Women who are pregnant or lactating * Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment * Patients with multiple complaints involving concomitant hip osteoarthritis * Inability to achieve proper positioning and inability to understand informed consent and protocol * History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00370799