Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To demonstrate whether:
i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.
ii. Adjuvant medications (Sarapin and Depo-Medrol) provide additional relief of cervical facet joint pain when used with facet joint nerve blocks.
To demonstrate whether or not there are clinically significant improvements in function of patients who receive cervical facet joint nerve block with or without Sarapin and Depo-Medrol (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.
To determine the adverse event profile in both groups.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- without steroid | Active Comparator | Cervical Facet Joint Nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) |
|
| Group 2 - with steroid | Active Comparator | Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical facet joint nerve blocks | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) | Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable. | over 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index (NDI) | Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability. | 2 years |
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laxmaiah Manchikanti, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Surgery Center | Paducah | Kentucky | 42003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20859313 | Result | Manchikanti L, Singh V, Falco FJ, Cash KA, Fellows B. Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in management of chronic neck pain: a randomized, double-blind controlled trial. Pain Physician. 2010 Sep-Oct;13(5):437-50. |
Not provided
Not provided
Not provided
Consecutive new patients presenting to interventional pain management practice with neck pain without suspected disc herniation or radiculitis.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Without Steroids | Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) |
| FG001 | Group 2 With Steroids | Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1- Without Steroid | Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) |
| BG001 | Group 2 - With Steroid | Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numeric Rating Scale (NRS) | Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable. | A sample size of 60 patients for each group was chosen. | Posted | Mean | Standard Deviation | units on a scale | over 2 years |
|
24 months
Infection, Nerve root or Spinal cord trauma
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1- Without Steroid | Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment |
Not provided
The study limitations include the lack of a placebo group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laxmaiah Manchikanti, MD | Pain Management Center of Paducah | 2705548373 | 101 | drlm@thepainmd.com |
Not provided
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| duration of pain | Mean | Standard Deviation | months |
|
|
|
|
| Secondary | Neck Disability Index (NDI) | Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Group 2 - With Steroid | Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone) | 0 | 60 | 0 | 60 |
Not provided
Not provided