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Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

Primary Purpose

Back Pain, Neck Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Xylocaine

Xylocaine and Celestone

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ambulatory Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Xylocaine

Xylocaine and Celestone

Arm Description

0.5% Xylocaine

0.5% Xylocaine with 6 mg of non-particulate Celestone.

Outcomes

Primary Outcome Measures

To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids

examined improvements between those who received and did not receive steroids

Secondary Outcome Measures

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

examined differences between those who received and did not receive steroids

To evaluate and compare the adverse event profile in all patients.

examined adverse event differences between those who received and did not receive steroids

Full Information

NCT ID

NCT01071369

First Posted

February 14, 2008

Last Updated

April 25, 2017

Sponsor

Pain Management Center of Paducah

1. Study Identification

Unique Protocol Identification Number

NCT01071369

Brief Title

Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

February 2008 (Actual)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pain Management Center of Paducah

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain, Neck Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Randomly assigned to groups

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xylocaine

Arm Type

Active Comparator

Arm Description

0.5% Xylocaine

Arm Title

Xylocaine and Celestone

Arm Type

Active Comparator

Arm Description

0.5% Xylocaine with 6 mg of non-particulate Celestone.

Intervention Type

Drug

Intervention Name(s)

Xylocaine

Intervention Description

0.5% Xylocaine

Intervention Type

Drug

Intervention Name(s)

Xylocaine and Celestone

Other Intervention Name(s)

Celestone

Intervention Description

non-particulate Celestone

Primary Outcome Measure Information:

Title

To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids

Description

examined improvements between those who received and 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.

Secondary Outcome Measure Information:

Title

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

Description

examined differences between those who received and 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.

Title

To evaluate and compare the adverse event profile in all patients.

Description

examined adverse event differences between those who received and 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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laxmaiah Manchikanti, MD

Organizational Affiliation

Ambulatory Surgery Center, Paducah

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ambulatory Surgery Center

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42001

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24077193

Citation

Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. A randomized, double-blind, active control trial of fluoroscopic cervical interlaminar epidural injections in chronic pain of cervical disc herniation: results of a 2-year follow-up. Pain Physician. 2013 Sep-Oct;16(5):465-78. Erratum In: Pain Physician. 2013 Nov-Dec;16(6):609.

Results Reference

derived

PubMed Identifier

22270749

Citation

Manchikanti L, Malla Y, Cash KA, McManus CD, Pampati V. Fluoroscopic epidural injections in cervical spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):E59-70.

Results Reference

derived

PubMed Identifier

22270734

Citation

Manchikanti L, Malla Y, Cash KA, McManus CD, Pampati V. Fluoroscopic cervical interlaminar epidural injections in managing chronic pain of cervical postsurgery syndrome: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):13-25.

Results Reference

derived

PubMed Identifier

21102973

Citation

Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. A preliminary report of a randomized double-blind, active controlled trial of fluoroscopic thoracic interlaminar epidural injections in managing chronic thoracic pain. Pain Physician. 2010 Nov-Dec;13(6):E357-69.

Results Reference

derived

PubMed Identifier

20648213

Citation

Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):E265-78.

Results Reference

derived

PubMed Identifier

20495586

Citation

Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. The effectiveness of fluoroscopic cervical interlaminar epidural injections in managing chronic cervical disc herniation and radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010 May-Jun;13(3):223-36. Erratum In: Pain Physician. 2010 Jul-Aurg;13(4):399-400.

Results Reference

derived

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

http://painphysicianjournal.com/current/pdf?article=MTk3Nw%3D%3D&journal=77

Available IPD/Information Comments

A Randomized, Double-Blind, Active Control Trial of Fluoroscopic Cervical Interlaminar Epidural Injections in Chronic Pain of Cervical Disc Herniation: Results of a 2-Year Follow-Up

Learn more about this trial

Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

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