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Effectiveness of Thoracic Facet Joint Nerve Blocks

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ClinicalTrials.gov Identifier: NCT00355706
Recruitment Status : Completed
First Posted : July 25, 2006
Results First Posted : November 26, 2013
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

Brief Summary:
  1. To demonstrate whether:

    i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.

    ii. Addition of Depo-steroid provides additional relief of thoracic facet joint pain when used with facet joint nerve blocks.

  2. To demonstrate whether or not there are clinically significant improvements in function of patients who receive thoracic facet joint nerve block with Depo-steroid compared to patients randomized to Group I who receive only local anesthetic blocks.
  3. To determine the adverse event profile in both groups

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Thoracic facet joint nerve blocks Not Applicable

Detailed Description:

Participants Study participants were recruited at the interventional pain management practice from consecutive new patients presenting with thoracic pain. One hundred patients were included and randomly assigned to one of 2 groups; either a local anesthetic only group (Group I) or a local anesthetic with steroid group (Group II), with 50 patients in each group. Patients meeting the inclusion criteria were eligible to undergo diagnostic thoracic facet joint nerve blocks. Only patients positive for controlled comparative local anesthetic blocks met the criteria for inclusion for thoracic medial branch blocks.

Inclusion and Exclusion Criteria Only patients with nonspecific mid-back or upper back pain without suspected disc herniation, radiculitis, thoracic fracture, stenosis, or intercostal neuritis were included. Further, patients suspected of disc-related pain with radicular symptoms were also excluded, based on radiologic testing and symptomatology involving radicular or chest wall pain. Patients also should have previously received conservative management with physical therapy, chiropractic manipulation exercises, drug therapy, and bed rest, and so forth, but continued to have pain.

Further inclusion criteria were a diagnosis of thoracic facet joint pain by means of controlled comparative local anesthetic blocks; patients who were over 18 years of age; patients with a history of chronic function-limiting mid-back or upper back pain of at least 6 months duration; and patients who where competent to understand the study protocol and provide voluntary, written informed consent, and participate in the outcome measurements. A negative or false-positive response to controlled comparative local anesthetic blocks, uncontrollable to heavy opioid use (morphine equivalent of 300 mg), uncontrolled

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation
Study Start Date : August 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Group I - without Steroids
Thoracic Facet Joint Nerve Blocks with Local Anesthetic(0.25% Bupivacaine)
Procedure: Thoracic facet joint nerve blocks
Thoracic medial branch blocks
Other Name: Thoracic medial branch blocks

Active Comparator: Group II - with steroid
Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Sterioids(0.15 mg of non-particulate betamethasone)
Procedure: Thoracic facet joint nerve blocks
Thoracic medial branch blocks
Other Name: Thoracic medial branch blocks




Primary Outcome Measures :
  1. Numeric Rating Scale [ Time Frame: 2 years ]
    Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.

  2. Oswestry Disability Index [ Time Frame: 24 months ]
    Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).


Other Outcome Measures:
  1. Opioid Intake [ Time Frame: 24 months ]
    Opioid intake(morphine equivalence mg)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Positive for facet joint pain with comparative local anesthetic blocks

Candidates are over 18 years of age

Subjects with a history of chronic, function limiting neck pain of at least six 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 Investigator, 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 The subject has not had recent surgical procedures within the last three months.

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Exclusion Criteria:

  • Negative or false-positive response to controlled comparative local anesthetic blocks

Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 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 intercranial pressure, pseudotumor cerebri, intercranial 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 hip osteoarthritis, will not be amenable to study 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355706


Locations
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United States, Kentucky
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42003
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
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Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00355706    
Other Study ID Numbers: protocol 5
First Posted: July 25, 2006    Key Record Dates
Results First Posted: November 26, 2013
Last Update Posted: March 10, 2020
Last Verified: March 2020
Keywords provided by Laxmaiah Manchikanti, MD, Pain Management Center of Paducah:
chronic low back pain
thoracic facet joint
nerve block
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations