Trial Outcomes & Findings for Effectiveness of Cervical Transforaminal Epidural Steroid Injection (NCT NCT04544683)
NCT ID: NCT04544683
Last Updated: 2024-04-10
Results Overview
Percentage of participants reporting 50% or greater improvement in index arm pain following an initial cervical transforaminal injection of steroid (CTFESI) at 1, 3, 6, and 12 months post-injection. Patient-reported arm pain intensity scores were captured at baseline and the designated follow-up time points using an 11-point Numeric Rating Scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable".
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
1 month, 3 months, 6 months, 12 months
Results posted on
2024-04-10
Participant Flow
Participant milestones
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
1 Month Follow-up
|
30
|
|
Overall Study
3 Month Follow-up
|
29
|
|
Overall Study
6 Month Follow-up
|
26
|
|
Overall Study
12 Month Follow-up
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
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|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Underwent cervical spine surgery
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
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|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 12.2 • n=33 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=33 Participants
|
|
Duration of Pain
6 weeks to 3 months
|
13 Participants
n=33 Participants
|
|
Duration of Pain
>3 months up to 6 months
|
20 Participants
n=33 Participants
|
|
Arm Pain Numeric Rating Scale
|
6.5 units on a scale
STANDARD_DEVIATION 1.4 • n=33 Participants
|
|
Neck Pain Numeric Rating Scale
|
4.5 units on a scale
STANDARD_DEVIATION 2.9 • n=33 Participants
|
|
Neck Disability Index (NDI-5)
|
9.4 units on a scale
STANDARD_DEVIATION 3.9 • n=33 Participants
|
|
EuroQol Health-Related Quality of Life (EQ-5D)
|
0.61 units on a scale
STANDARD_DEVIATION 0.17 • n=33 Participants
|
|
Chronic Pain Sleep Inventory (CPSI)
|
51.9 units on a scale
STANDARD_DEVIATION 30.7 • n=33 Participants
|
|
Medication Quantification Scale (MQS) III Score
|
6.0 units on a scale
STANDARD_DEVIATION 4.8 • n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C4 · Yes
|
0 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C4 · No
|
33 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C5 · Yes
|
0 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C5 · No
|
33 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C6 · Yes
|
18 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C6 · No
|
15 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C7 · Yes
|
14 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C7 · No
|
19 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C8 · Yes
|
1 Participants
n=33 Participants
|
|
Affected Cervical Spinal Nerve Root Levels
C8 · No
|
32 Participants
n=33 Participants
|
|
Cervical Disc Herniation on MRI
Yes
|
11 Participants
n=33 Participants
|
|
Cervical Disc Herniation on MRI
No
|
22 Participants
n=33 Participants
|
|
Cervical Disc-Osteophyte Complex on MRI
Yes
|
15 Participants
n=33 Participants
|
|
Cervical Disc-Osteophyte Complex on MRI
No
|
18 Participants
n=33 Participants
|
|
Cervical Foraminal Stenosis Related to Bony Elements on MRI
Yes
|
9 Participants
n=33 Participants
|
|
Cervical Foraminal Stenosis Related to Bony Elements on MRI
No
|
24 Participants
n=33 Participants
|
|
Foraminal Stenosis Severity (Park Classification)
Grade 0 or 1
|
9 Participants
n=33 Participants
|
|
Foraminal Stenosis Severity (Park Classification)
Grade 2
|
7 Participants
n=33 Participants
|
|
Foraminal Stenosis Severity (Park Classification)
Grade 3
|
17 Participants
n=33 Participants
|
|
Tobacco Use
History of tobacco use · Yes
|
3 Participants
n=33 Participants
|
|
Tobacco Use
History of tobacco use · No
|
30 Participants
n=33 Participants
|
|
Tobacco Use
Current tobacco use · Yes
|
2 Participants
n=33 Participants
|
|
Tobacco Use
Current tobacco use · No
|
31 Participants
n=33 Participants
|
|
History of Depression
Yes
|
9 Participants
n=33 Participants
|
|
History of Depression
No
|
24 Participants
n=33 Participants
|
|
History of Anxiety
Yes
|
7 Participants
n=33 Participants
|
|
History of Anxiety
No
|
26 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsPercentage of participants reporting 50% or greater improvement in index arm pain following an initial cervical transforaminal injection of steroid (CTFESI) at 1, 3, 6, and 12 months post-injection. Patient-reported arm pain intensity scores were captured at baseline and the designated follow-up time points using an 11-point Numeric Rating Scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable".
Outcome measures
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Arm Pain Score
1 month
|
19 Participants
|
|
Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Arm Pain Score
3 months
|
23 Participants
|
|
Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Arm Pain Score
6 months
|
20 Participants
|
|
Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Arm Pain Score
12 months
|
20 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsPercentage of participants reporting 50% or greater improvement in index neck pain following an initial cervical transforaminal injection of steroid (CTFESI) at 1, 3, 6, and 12 months post-injection. Patient-reported arm pain intensity scores were captured at baseline and the designated follow-up time points using an 11-point Numeric Rating Scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable".
Outcome measures
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Neck Pain Score
1 month
|
11 Participants
|
|
Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Neck Pain Score
3 months
|
14 Participants
|
|
Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Neck Pain Score
6 months
|
9 Participants
|
|
Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Neck Pain Score
12 months
|
13 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsThe 5-Item Neck Disability Index (NDI-5) is an assessment tool measuring patients' self-reported functional limitations due to neck pain. The range of possible scores is 0 to 24, with higher scores indicating greater functional impairment in activities of daily living.
Outcome measures
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
The Number of Participants With a ≥30% Improvement in Neck Disability Index (NDI-5)
1 month
|
20 Participants
|
|
The Number of Participants With a ≥30% Improvement in Neck Disability Index (NDI-5)
3 months
|
22 Participants
|
|
The Number of Participants With a ≥30% Improvement in Neck Disability Index (NDI-5)
6 months
|
19 Participants
|
|
The Number of Participants With a ≥30% Improvement in Neck Disability Index (NDI-5)
12 months
|
22 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsThe EuroQol Health-Related Quality of Life 5-Dimension (EQ-5D) is an instrument used in clinical and research settings to assess overall quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores are reported as an index ranging from 0 to 1, where 0 represents death and 1 represents perfect health.
Outcome measures
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
The Number of Participants With a ≥0.03 Point Increase in EuroQol Health-Related Quality of Life (EQ-5D) Score
1 month
|
25 Participants
|
|
The Number of Participants With a ≥0.03 Point Increase in EuroQol Health-Related Quality of Life (EQ-5D) Score
3 months
|
25 Participants
|
|
The Number of Participants With a ≥0.03 Point Increase in EuroQol Health-Related Quality of Life (EQ-5D) Score
6 months
|
19 Participants
|
|
The Number of Participants With a ≥0.03 Point Increase in EuroQol Health-Related Quality of Life (EQ-5D) Score
12 months
|
23 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsThe Medication Quantification Scale (MQS) III is used to objectively quantify and monitor pain medication use (including opioid and non-opioid medications) in chronic pain populations. The lowest possible MQS III score is 0, indicating no current usage of any analgesic drugs assessed by this instrument. It is not possible to define a maximum score value because no theoretical upper limit exists. However, higher scores reflect greater negative impacts of a pain medication regimen, and a score of 6.8 points on the MQS III is comparable to 10 daily morphine equivalents in milligrams.
Outcome measures
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
The Number of Participants With a ≥6.8 Point Change in Medication Quantification Scale (MQS-III) Score
1 month
|
4 Participants
|
|
The Number of Participants With a ≥6.8 Point Change in Medication Quantification Scale (MQS-III) Score
3 months
|
4 Participants
|
|
The Number of Participants With a ≥6.8 Point Change in Medication Quantification Scale (MQS-III) Score
6 months
|
6 Participants
|
|
The Number of Participants With a ≥6.8 Point Change in Medication Quantification Scale (MQS-III) Score
12 months
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsThe Chronic Pain Sleep Inventory (CPSI) is an instrument used to assess the extent to which pain interferes with sleep quality in chronic pain populations. Scores range from 0 to 100, with higher values indicating greater levels of pain-mediated sleep interference.
Outcome measures
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
The Number of Participants With a ≥30% Change in Chronic Pain Sleep Inventory (CPSI) Score
1 month
|
9 Participants
|
|
The Number of Participants With a ≥30% Change in Chronic Pain Sleep Inventory (CPSI) Score
3 months
|
12 Participants
|
|
The Number of Participants With a ≥30% Change in Chronic Pain Sleep Inventory (CPSI) Score
6 months
|
5 Participants
|
|
The Number of Participants With a ≥30% Change in Chronic Pain Sleep Inventory (CPSI) Score
12 months
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsA measure of how many participants indicated an improvement in their ability to accomplish 4 key activities: driving, exercising, sleeping and sitting.
Outcome measures
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
Participant Improvement in Ability to Accomplish ≥3 Key Activities From Clinical Outcome Measurement Brief Instrument (COMBI)
1 month
|
11 Participants
|
|
Participant Improvement in Ability to Accomplish ≥3 Key Activities From Clinical Outcome Measurement Brief Instrument (COMBI)
3 months
|
18 Participants
|
|
Participant Improvement in Ability to Accomplish ≥3 Key Activities From Clinical Outcome Measurement Brief Instrument (COMBI)
6 months
|
14 Participants
|
|
Participant Improvement in Ability to Accomplish ≥3 Key Activities From Clinical Outcome Measurement Brief Instrument (COMBI)
12 months
|
16 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsPatient Global Impression of Change is a 7-point scale measuring participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved").
Outcome measures
| Measure |
Cervical Pain for 6 Months or Less and Scheduled for TFESI
n=33 Participants
Consenting participants who met eligibility criteria were enrolled into the study. The baseline examination and all baseline questionnaires were completed within 2 weeks before the first cervical TFESI. All follow-up measures were obtained at routine scheduled follow-up by clinic visit or telephone occurred at 1 month (+/- 1 week), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month).
Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate: Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
|
|---|---|
|
≥6 Patient Global Impression of Change (PGIC) Score
1 month
|
18 Participants
|
|
≥6 Patient Global Impression of Change (PGIC) Score
3 months
|
21 Participants
|
|
≥6 Patient Global Impression of Change (PGIC) Score
6 months
|
15 Participants
|
|
≥6 Patient Global Impression of Change (PGIC) Score
12 months
|
18 Participants
|
Adverse Events
Cervical Pain for 6 Months or Less and Scheduled for TFESI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aaron Conger, MD
University of Utah Orthopaedic Center/ Physical Medicine & Rehabilitation
Phone: 801-587-1493
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place