Treatment of Chronic Low Back and Lower Extremity Pain

Pain Management Center of Paducah

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Lumbar Interlaminar Epidural; Procedure: Lumbar Interlaminar Epidural injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00681447

protocol 15

Details and patient eligibility

About

1. To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
2. To evaluate and compare the adverse event profile in all patients.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of at least 18 years of age
• Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration
• Subjects who are able to give voluntary, written informed consent to participate in this investigation
• Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
• Subjects have not had recent surgical procedures within the last 3 months.

Exclusion criteria

• Cauda Equina symptoms and/or compressive radiculopathy
• Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
• Uncontrolled major depression or uncontrolled psychiatric disorders
• Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.
• Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
• 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, due to the overlap of pain complaints
• Inability to achieve appropriate 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
• Previous surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Group I

Other group

Description:

Lumbar interlaminar epidural injection with local anesthetic only

Treatment:

Procedure: Lumbar Interlaminar Epidural

Procedure: Lumbar Interlaminar Epidural injection

Group II

Other group

Description:

Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone

Treatment:

Procedure: Lumbar Interlaminar Epidural

Procedure: Lumbar Interlaminar Epidural injection