Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

NCT01071369 | Completed Phase 4 FDA Drug

• 1 other identifier: protocol 16
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (2)

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

  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.

  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.

Study Arms (2)

Xylocaine

ACTIVE COMPARATOR

0.5% Xylocaine

Drug: Xylocaine

Xylocaine and Celestone

ACTIVE COMPARATOR

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

Drug: Xylocaine; Drug: Xylocaine and Celestone

Interventions

Xylocaine DRUG

0.5% Xylocaine

Xylocaine; Xylocaine and Celestone

Xylocaine and Celestone DRUG

non-particulate Celestone

Also known as: Celestone

Xylocaine and Celestone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pain Management Center of Paducah: lead

Study Sites (1)

Ambulatory Surgery Center

Paducah, Kentucky, 42001, United States

Location

Related Publications (6)

• 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.

  PMID: 24077193 DERIVED

• 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.

  PMID: 22270749 DERIVED

• 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.

  PMID: 22270734 DERIVED

• 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.

  PMID: 21102973 DERIVED

• 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.

  PMID: 20648213 DERIVED

• 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.

  PMID: 20495586 DERIVED

MeSH Terms

Conditions

Back Pain; Neck Pain

Interventions

Lidocaine; Betamethasone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Laxmaiah Manchikanti, MD

  Ambulatory Surgery Center, Paducah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomly assigned to groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 19, 2010
• Study Start: February 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2012
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)