Treatment of Chronic Thoracic and Neck and Upper Extremity Pain
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ClinicalTrials.gov Identifier: NCT01071369 |
Recruitment Status
:
Completed
First Posted
: February 19, 2010
Last Update Posted
: April 27, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Back Pain Neck Pain | Drug: Xylocaine Drug: Xylocaine and Celestone | Phase 4 |
This is a Single-center, prospective, controlled, double-blind, randomized study in thoracic and cervical regions.
Patients are studied in 2 groups in each region.
- Group I-local anesthetic only.
- Group II-local anesthetic with 6 mg of non-particulate Celestone.
All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Randomly assigned to groups |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Cervical and Thoracic Interlaminar Epidural Injections in Thoracic and Cervical Disc Herniation, Discogenic Pain, and Post-Cervical Laminectomy Syndrome |
Actual Study Start Date : | February 2008 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Xylocaine
0.5% Xylocaine
|
Drug: Xylocaine
0.5% Xylocaine
|
Active Comparator: Xylocaine and Celestone
0.5% Xylocaine with 6 mg of non-particulate Celestone.
|
Drug: Xylocaine
0.5% Xylocaine
Drug: Xylocaine and Celestone
non-particulate Celestone
Other Name: Celestone
|
- To demonstrate clinically significant improvements or lack thereof with the 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. ]examined improvements between those who received and did not receive 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. [ 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. ]examined differences between those who received and did not receive steroids
- 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. ]examined adverse event differences between those who received and did not receive steroids

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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 thoracic or cervical pain with or without upper extremity 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:
- 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 shoulder 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.

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): NCT01071369
United States, Kentucky | |
Ambulatory Surgery Center | |
Paducah, Kentucky, United States, 42001 |
Principal Investigator: | Laxmaiah Manchikanti, MD | Ambulatory Surgery Center, Paducah |
Study Data/Documents: Clinical Study Report

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah |
ClinicalTrials.gov Identifier: | NCT01071369 History of Changes |
Other Study ID Numbers: |
protocol 16 |
First Posted: | February 19, 2010 Key Record Dates |
Last Update Posted: | April 27, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
Back Pain Neck Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Lidocaine Betamethasone benzoate Betamethasone-17,21-dipropionate Betamethasone Betamethasone Valerate Betamethasone sodium phosphate Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Respiratory System Agents |