Treatment of Chronic Low Back and Lower Extremity Pain
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00681447 |
Recruitment Status :
Completed
First Posted : May 21, 2008
Last Update Posted : October 21, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
- 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.
- To evaluate and compare the adverse event profile in all patients.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain | Procedure: Lumbar Interlaminar Epidural Procedure: Lumbar Interlaminar Epidural injection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
---|---|
Group I
Lumbar interlaminar epidural injection with local anesthetic only
|
Procedure: Lumbar Interlaminar Epidural
0.5% Xylocaine and non-particulate Celestone Procedure: Lumbar Interlaminar Epidural injection
0.5% Xylocaine and non-particulate Celestone |
Group II
Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone
|
Procedure: Lumbar Interlaminar Epidural
0.5% Xylocaine and non-particulate Celestone Procedure: Lumbar Interlaminar Epidural injection
0.5% Xylocaine and non-particulate Celestone |
- To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ]
- To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ]
- To evaluate and compare the adverse event profile in all patients. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681447
United States, Kentucky | |
Ambulatory Surgery Center | |
Paducah, Kentucky, United States, 42001 |
Principal Investigator: | Laxmaiah Manchikanti, MD | Ambulatory Surgery Center, Paducah |
Responsible Party: | Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah |
ClinicalTrials.gov Identifier: | NCT00681447 |
Other Study ID Numbers: |
protocol 15 |
First Posted: | May 21, 2008 Key Record Dates |
Last Update Posted: | October 21, 2015 |
Last Verified: | October 2015 |
lumbar disc herniation discogenic pain lumbar interlaminar epidural injections |
Low Back Pain Back Pain Pain Neurologic Manifestations |