Neck Pain, Radicular; Neuropathic, Cervical
Conditions
Brief summary
Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck, scapula or arm. The diagnosis of radicular pain is made clinically by history and physical examination, supported by imaging studies and electrodiagnostic tests. No study has compared the differences in pain, medication utilization, functional outcomes, or patient satisfaction between interlaminar and targeted epidural injections in the cervical spine. In theory, the technique of targeted epidural steroid delivery with a catheter has a lower risk of accidental vascular trespass or disc penetration during the procedure, and far less risk of dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as compared with the interlaminar technique. The investigators hypothesize that this technique results in superior pain control, decreased medication use, improved function and fewer repeat injections. This data could improve patient safety and affect the evolving treatment guidelines for cervical epidural injections.
Detailed description
Cervical radicular pain is a common, painful, disabling problem, often treated by epidural steroid injection (ESI). Two techniques of steroid delivery into the cervical epidural space include the transforaminal and interlaminar approaches. We aimed to determine if the CIESI with versus without a catheter is associated with superior clinical outcomes at follow-up. We hypothesized that the use of a targeted epidural catheter technique would result in superior pain control, function, decreased analgesic use, and lower surgical incidence as compared to standard CIESI at C7-T1.
Interventions
DRUGTriamcinolone 80mg
C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All patients ages 18-75 with C2-6 unilateral radicular pain who are scheduled to undergo cervical epidural steroid injection treatment. * Pain lasting greater than 2 weeks. * Pain resistant to a trial of conservative therapy (i.e. oral steroids,nonsteroidal anti-inflammatory drugs, opioids, muscle relaxants, physical therapy or chiropractic care)
Exclusion criteria
* Patient refusal. * Lack of consent. * Systemic infection or local infection over planned injection site in posterior cervical spine. * Bleeding disorder, current use of anticoagulants or anti-platelet medications. * Intrinsic spinal cord lesions in the cervical region. * History of central neurologic, cerebrovascular, demyelinating or muscular disease. * Concomitant use of oral or injected steroids. * Allergy to medications being used for injection procedures. * Inability to communicate with staff or to participate in follow up. * Pregnancy. * Inability to perform handgrip or arm strength testing. * Cognitive deficit or motor neuron disease. * Daily opiate use that preceded the onset of cervical radicular symptoms or daily opiate use exceeding 3 months prior to study inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain | 1 month | The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period. Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain). Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III) | 1 month | The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject's medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus). |
| Patient Global Impression of Change Score (PGIC) Less Than 3 | 1 month | PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse. A PGIC score less than 3 means the patient reported much improved to very much improved. |
| Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score | 1 month | This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Catheter Delivery Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
No Catheter Delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. | 40 |
| Catheter Targeted Delivery Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Catheter targeted delivery will be used to deliver the medication.
Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. | 36 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
Baseline characteristics
| Characteristic | Catheter Targeted Delivery | No Catheter Delivery | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 37 Participants | 69 Participants |
| Age, Continuous | 50 years | 47 years | 49 years |
| Region of Enrollment United States | 36 participants | 40 participants | 76 participants |
| Sex: Female, Male Female | 20 Participants | 25 Participants | 45 Participants |
| Sex: Female, Male Male | 16 Participants | 15 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 / 40 | 0 / 36 |
| serious Total, serious adverse events | 0 / 40 | 0 / 36 |
Outcome results
Primary
Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain
The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period. Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain). Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants)
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Catheter Delivery | Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain | 60 percentage of participants |
| Catheter Targeted Delivery | Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain | 72 percentage of participants |
p-value: 0.23Fisher Exact
Secondary
Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)
The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject's medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus).
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Catheter Delivery | Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III) | 13 Participants |
| Catheter Targeted Delivery | Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III) | 9 Participants |
p-value: 0.47Chi-squared
Secondary
Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score
This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent.
Time frame: 1 month
Population: Both demonstrate a difference from pretreatment baseline (P=0.05).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Catheter Delivery | Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score | 23 Participants |
| Catheter Targeted Delivery | Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score | 24 Participants |
p-value: 0.41Chi-squared
Secondary
Patient Global Impression of Change Score (PGIC) Less Than 3
PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse. A PGIC score less than 3 means the patient reported much improved to very much improved.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Catheter Delivery | Patient Global Impression of Change Score (PGIC) Less Than 3 | 22 Participants |
| Catheter Targeted Delivery | Patient Global Impression of Change Score (PGIC) Less Than 3 | 24 Participants |
p-value: 0.3Chi-squared