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Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT01071369
First received: February 14, 2008
Last updated: June 20, 2013
Last verified: June 2013

February 14, 2008
June 20, 2013
February 2008
February 2008   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01071369 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Chronic Thoracic and Neck and Upper Extremity Pain
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Back Pain
  • Neck Pain
  • Drug: Xylocaine
    0.5% Xylocaine
    Other Name: Xylocaine
  • Drug: Xylocaine and Celestone
    non-particulate Celestone
    Other Name: Celestone
  • Active Comparator: Xylocaine
    0.5% Xylocaine
    Intervention: Drug: Xylocaine
  • Active Comparator: Xylocaine and Celestone
    0.5% Xylocaine with 6 mg of non-particulate Celestone.
    Interventions:
    • Drug: Xylocaine
    • Drug: Xylocaine and Celestone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
December 2013
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01071369
protocol 16
No
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
Pain Management Center of Paducah
Not Provided
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center, Paducah
Pain Management Center of Paducah
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP