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
  Purpose

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.


Condition Intervention
Back Pain
Neck Pain
Drug: Xylocaine
Drug: Xylocaine and Celestone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:
  • 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 ]

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. [ 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 ]

Enrollment: 240
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Xylocaine
0.5% Xylocaine
Drug: Xylocaine
0.5% Xylocaine
Other Name: Xylocaine
Active Comparator: Xylocaine and Celestone
0.5% Xylocaine with 6 mg of non-particulate Celestone.
Drug: Xylocaine
0.5% Xylocaine
Other Name: Xylocaine
Drug: Xylocaine and Celestone
non-particulate Celestone
Other Name: Celestone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071369

Locations
United States, Kentucky
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42001
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center, Paducah
  More Information

No publications provided by Pain Management Center of Paducah

Additional 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
Study First Received: February 14, 2008
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 29, 2014