Neck Pain
Conditions
Brief summary
1. 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. 2. 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. 3. To determine the adverse event profile in both groups.
Interventions
PROCEDURECervical facet joint nerve blocks
Sponsors
Pain Management Center of Paducah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | over 2 years | Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) | 2 years | 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. |
Countries
United States
Participant flow
Recruitment details
Consecutive new patients presenting to interventional pain management practice with neck pain without suspected disc herniation or radiculitis.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 60 |
| 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) | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Group 2 - With Steroid | Group 1- Without Steroid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 60 Participants | 120 Participants |
| Age Continuous | 43 years STANDARD_DEVIATION 14.1 | 46 years STANDARD_DEVIATION 13.2 | 44 years STANDARD_DEVIATION 13.7 |
| duration of pain | 87 months STANDARD_DEVIATION 104 | 120 months STANDARD_DEVIATION 122 | 103 months STANDARD_DEVIATION 174 |
| Sex: Female, Male Female | 48 Participants | 41 Participants | 89 Participants |
| Sex: Female, Male Male | 12 Participants | 19 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Numeric Rating Scale (NRS)
Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.
Time frame: over 2 years
Population: A sample size of 60 patients for each group was chosen.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Without Steroids | Numeric Rating Scale (NRS) | Baseline | 8.2 units on a scale | Standard Deviation 0.8 |
| Group 1 - Without Steroids | Numeric Rating Scale (NRS) | 2 years | 3.5 units on a scale | Standard Deviation 1.1 |
| Group 2 - With Steroids | Numeric Rating Scale (NRS) | Baseline | 8.2 units on a scale | Standard Deviation 1.1 |
| Group 2 - With Steroids | Numeric Rating Scale (NRS) | 2 years | 3.2 units on a scale | Standard Deviation 1 |
p-value: <0.05Paired t test
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.
Time frame: 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Without Steroids | Neck Disability Index (NDI) | Baseline | 25.4 units on a scale | Standard Deviation 5.7 |
| Group 1 - Without Steroids | Neck Disability Index (NDI) | 24 months | 11.6 units on a scale | Standard Deviation 5.2 |
| Group 2 - With Steroids | Neck Disability Index (NDI) | Baseline | 25.1 units on a scale | Standard Deviation 5 |
| Group 2 - With Steroids | Neck Disability Index (NDI) | 24 months | 11.0 units on a scale | Standard Deviation 4.7 |
p-value: <0.05Paired t test