Treatment of Chronic Thoracic and Neck and Upper Extremity Pain
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ClinicalTrials.gov Identifier: NCT01071369 |
Recruitment Status
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Completed
First Posted
: February 19, 2010
Last Update Posted
: April 27, 2017
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Sponsor:
Pain Management Center of Paducah
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
Tracking Information | |||||||
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First Submitted Date ICMJE | February 14, 2008 | ||||||
First Posted Date ICMJE | February 19, 2010 | ||||||
Last Update Posted Date | April 27, 2017 | ||||||
Actual Study Start Date ICMJE | February 2008 | ||||||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
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. ] | ||||||
Change History | Complete list of historical versions of study NCT01071369 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Treatment of Chronic Thoracic and Neck and Upper Extremity Pain | ||||||
Official Title ICMJE | 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 | ||||||
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.
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Masking Description: Randomly assigned to groups Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
120 | ||||||
Original Estimated Enrollment ICMJE |
240 | ||||||
Actual Study Completion Date | June 2012 | ||||||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01071369 | ||||||
Other Study ID Numbers ICMJE | protocol 16 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Laxmaiah Manchikanti, MD, Pain Management Center of Paducah | ||||||
Study Sponsor ICMJE | Pain Management Center of Paducah | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pain Management Center of Paducah | ||||||
Verification Date | April 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |