Herniated Disk, Radiculopathy
Conditions
Keywords
spine surgery, low back pain, herniated disk
Brief summary
Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by disc herniation. Among the various surgical techniques practiced the percutaneous discectomy occupies its space since the first description of the technique by Hijikata, 1975. Throughout, many techniques have been described. Studies indicate that the treatment was successful for pain and disability resulting from herniated disc associated with radiculopathy small. However, some methods remove very small amounts of tissue with little change in volume of the disc. Thus, studies on the cadaver with Percutaneous Diskectomy by SpineJet ® showed more macroscopic changes of the disc with a predictable amount of removal and significant disc material. The Percutaneous Diskectomy by SpineJet ® is a new technique of percutaneous diskectomy which creates a suction effect in tissues adjacent to the exit point of the fluid and the opening point of the collector. However, no studies have examined the effect of the Percutaneous Diskectomy by SpineJet ® in humans about the disk size after treatment or measures of disc degeneration by imaging methods or how these characteristics might correlate with clinical outcomes. Thus, the study will compare outcomes of patients with contained or extruded disc herniation, with complaints of radiculopathy, concordant with the imaging findings. With treatment by surgical technique or the traditional by SpineJet ®, in order to determine whether percutaneous discectomy with SpineJet ® will produce results comparable to open microdiskectomy.
Interventions
PROCEDUREOpen microdiscectomy
The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision.
PROCEDUREPercutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
Yes
Inclusion criteria
* single disc herniation, posterolateral, at any lumbar level, with a size of up to 1 / 3 of the spinal canal sagittal diameter, with radicular pain correlated with findings at MRI * Failure of nonoperative treatment with at least one anti-inflammatory medication and at least two weeks of physical therapy within a period of 6 months * acceptance of completion of informed consent
Exclusion criteria
* Force \<4 / 5 in a muscle group in the lower limb * Herniated Disc extrusa large (\> 1 / 3 of the sagittal canal diameter) or sequestered herniation * moderate to grade stenosis of the central canal, lateral recess or foramen * Surgery in the previous level involved * Herniated disc at another level in the affected side * Loss of disc height significantly (\> 60%) compared with the adjacent higher level * Infection at the insertion of the device * Pregnancy * Any illness or medications that contraindicate surgical treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS for Lumbar Pain in 3 Months | VAS for Lumbar Pain at 3 Months | Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| Oswestry Disability Index (ODI) - 3th Month | 3th month | Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Evaluation | 6th month | Will be measured dichotomously: (present or absent) Variables: Infection; residual pain; herniation recurrency |
| VAS for Lumbar - 1st Week | 1st week from surgery | Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| VAS for Lumbar 1st Month | 1st month from surgery | Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| VAS for Lumbar Pain - 3rd Month | 3rd month from surgery | Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| VAS for Lumbar Pain - 6th Month | 6th month from surgery | Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| VAS for Lumbar Pain - 12th Month | 12th month from surgery | Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| Oswestry Disability Index (ODI) - 1st Week | 1st week minus baseline | Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome. |
| Oswestry Disability Index (ODI) - 1st Month | 1st month from baseline | Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome. |
| Oswestry Disability Index (ODI) - 6th Month | 6th month from surgery | Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome. |
| Oswestry Disability Index (ODI) - 12th Month | 12th month from surgery | Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome. |
| VAS for Leg Pain - 1st Week | 1st week from surgery | Pain Score for leg pain- Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| VAS for Leg Pain - 1st Month | 1st month from surgery | Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| VAS for Leg Pain - 3rd Month | 3rd month from surgery | Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| VAS for Leg Pain - 6rd Month | 6th month from surgery | Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome. |
| VAS for Leg Pain - 12th Month | 12th month from surgery | pain scale - VAS for leg pain - 12th month |
Countries
Brazil
Participant flow
Recruitment details
Patients referred to our tertiary hospital for lumbar back pain were recruited. They were included in the study if they had disc protrusion or small herniation in only one level, with magnetic resonance imaging findings compatible with symptoms, without neurological deficits, and with no resolution after six weeks of conservative treatment.
Pre-assignment details
Exclusion criteria were: neurological changes during conservative treatment, pregnancy, clinical status not adequate for surgical procedures, non-adherence to informed consent form. After inclusion in the study, patients were evaluated for pain and function and then randomly allocated in two groups
Participants by arm
| Arm | Count |
|---|---|
| OMicro This group will be formed by randomization, which gets out surgery to open microdiscectomy
Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision. | 20 |
| SJet This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | OMicro | SJet | Total |
|---|---|---|---|
| Age, Continuous | 41.2 years STANDARD_DEVIATION 9.3 | 44.9 years STANDARD_DEVIATION 9.4 | 43 years STANDARD_DEVIATION 9.4 |
| Manual labor no | 7 participants | 8 participants | 15 participants |
| Manual labor yes | 13 participants | 12 participants | 25 participants |
| Married No | 2 participants | 7 participants | 9 participants |
| Married Yes | 18 participants | 13 participants | 31 participants |
| Months away from work | 4.65 Months STANDARD_DEVIATION 6.52 | 8.67 Months STANDARD_DEVIATION 14.4 | 5.8 Months STANDARD_DEVIATION 9.14 |
| Months feeling pain | 16.25 Months STANDARD_DEVIATION 20.2 | 33.5 Months STANDARD_DEVIATION 47.3 | 24.87 Months STANDARD_DEVIATION 36.96 |
| ODI preoperatively | 33.65 units on a scale STANDARD_DEVIATION 9.33 | 26.35 units on a scale STANDARD_DEVIATION 6.6 | 30 units on a scale STANDARD_DEVIATION 8.8 |
| Opioid use no | 7 participants | 9 participants | 16 participants |
| Opioid use yes | 13 participants | 11 participants | 24 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 13 Participants | 30 Participants |
| Receiving government benefit no | 7 participants | 10 participants | 17 participants |
| Receiving government benefit yes | 13 participants | 10 participants | 23 participants |
| Region of Enrollment Brazil | 20 participants | 20 participants | 40 participants |
| Schooling <8 years | 10 participants | 10 participants | 20 participants |
| Schooling >=8 years | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
| VAS for leg pain preoperatively | 84.2 units on a scale STANDARD_DEVIATION 23 | 73.6 units on a scale STANDARD_DEVIATION 22 | 78.9 units on a scale STANDARD_DEVIATION 22 |
| VAS for lumbar pain preoperatively | 77.2 units on a scale STANDARD_DEVIATION 27 | 63 units on a scale STANDARD_DEVIATION 30 | 69.2 units on a scale STANDARD_DEVIATION 29 |
| Working currently no | 14 participants | 10 participants | 24 participants |
| Working currently yes | 6 participants | 10 participants | 16 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Oswestry Disability Index (ODI) - 3th Month
Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.
Time frame: 3th month
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | Oswestry Disability Index (ODI) - 3th Month | 17.05 units on a scale | Standard Deviation 10.9 |
| SJet | Oswestry Disability Index (ODI) - 3th Month | 16.85 units on a scale | Standard Deviation 12 |
p-value: <0.0595% CI: [-7.15, 7.55]t-test, 2 sided
Primary
VAS for Lumbar Pain in 3 Months
Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: VAS for Lumbar Pain at 3 Months
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Lumbar Pain in 3 Months | 2.63 units on a scale | Standard Deviation 2.9 |
| SJet | VAS for Lumbar Pain in 3 Months | 4.53 units on a scale | Standard Deviation 3.47 |
p-value: 0.0595% CI: [-4.05, 0.26]t-test, 2 sided
Secondary
Clinical Evaluation
Will be measured dichotomously: (present or absent) Variables: Infection; residual pain; herniation recurrency
Time frame: 6th month
Population: Infection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OMicro | Clinical Evaluation | Infection | 1 participants |
| OMicro | Clinical Evaluation | residual pain | 3 participants |
| OMicro | Clinical Evaluation | herniation recurrency | 2 participants |
| SJet | Clinical Evaluation | Infection | 1 participants |
| SJet | Clinical Evaluation | residual pain | 4 participants |
| SJet | Clinical Evaluation | herniation recurrency | 1 participants |
p-value: <0.05Fisher Exact
Secondary
Oswestry Disability Index (ODI) - 12th Month
Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.
Time frame: 12th month from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | Oswestry Disability Index (ODI) - 12th Month | 11 units on a scale | Standard Deviation 6.82 |
| SJet | Oswestry Disability Index (ODI) - 12th Month | 12.7 units on a scale | Standard Deviation 12.2 |
p-value: <0.0595% CI: [-8.16, 4.76]t-test, 2 sided
Secondary
Oswestry Disability Index (ODI) - 1st Month
Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.
Time frame: 1st month from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | Oswestry Disability Index (ODI) - 1st Month | 19.25 units on a scale | Standard Deviation 10.23 |
| SJet | Oswestry Disability Index (ODI) - 1st Month | 10.78 units on a scale | Standard Deviation 2.41 |
p-value: <0.0595% CI: [-4.4, 8.9]t-test, 2 sided
Secondary
Oswestry Disability Index (ODI) - 1st Week
Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.
Time frame: 1st week minus baseline
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | Oswestry Disability Index (ODI) - 1st Week | 23.25 units on a scale | Standard Deviation 9.37 |
| SJet | Oswestry Disability Index (ODI) - 1st Week | 20 units on a scale | Standard Deviation 8.13 |
p-value: <0.0595% CI: [-2.36, 8.8]t-test, 2 sided
Secondary
Oswestry Disability Index (ODI) - 6th Month
Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.
Time frame: 6th month from surgery
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | Oswestry Disability Index (ODI) - 6th Month | 15.37 units on a scale | Standard Deviation 11.45 |
| SJet | Oswestry Disability Index (ODI) - 6th Month | 15.1 units on a scale | Standard Deviation 11.37 |
p-value: <0.0595% CI: [-7.14, 7.67]t-test, 2 sided
Secondary
VAS for Leg Pain - 12th Month
pain scale - VAS for leg pain - 12th month
Time frame: 12th month from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Leg Pain - 12th Month | 3.37 units on a scale | Standard Deviation 3.8 |
| SJet | VAS for Leg Pain - 12th Month | 2.67 units on a scale | Standard Deviation 3.3 |
p-value: <0.0595% CI: [-1.67, 3.08]t-test, 2 sided
Secondary
VAS for Leg Pain - 1st Month
Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 1st month from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Leg Pain - 1st Month | 2.96 units on a scale | Standard Deviation 3.4 |
| SJet | VAS for Leg Pain - 1st Month | 2.76 units on a scale | Standard Deviation 3.41 |
p-value: <0.0595% CI: [-2, 2.4]t-test, 2 sided
Secondary
VAS for Leg Pain - 1st Week
Pain Score for leg pain- Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 1st week from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Leg Pain - 1st Week | 4.3 units on a scale | Standard Deviation 2.92 |
| SJet | VAS for Leg Pain - 1st Week | 2.61 units on a scale | Standard Deviation 2.67 |
p-value: <0.0595% CI: [-0.12, 3.46]t-test, 2 sided
Secondary
VAS for Leg Pain - 3rd Month
Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 3rd month from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Leg Pain - 3rd Month | 17.05 units on a scale | Standard Deviation 10.9 |
| SJet | VAS for Leg Pain - 3rd Month | 16.85 units on a scale | Standard Deviation 12 |
p-value: <0.0595% CI: [-2.55, 1.85]t-test, 2 sided
Secondary
VAS for Leg Pain - 6rd Month
Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 6th month from surgery
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Leg Pain - 6rd Month | 2.84 units on a scale | Standard Deviation 3.82 |
| SJet | VAS for Leg Pain - 6rd Month | 2.88 units on a scale | Standard Deviation 3.14 |
p-value: <0.0595% CI: [-2.29, 2.23]t-test, 2 sided
Secondary
VAS for Lumbar 1st Month
Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 1st month from surgery
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Lumbar 1st Month | 3.34 units on a scale | Standard Error 2.92 |
| SJet | VAS for Lumbar 1st Month | 4.06 units on a scale | Standard Error 3.31 |
p-value: <0.0595% CI: [-2.76, 1.33]t-test, 2 sided
Secondary
VAS for Lumbar - 1st Week
Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 1st week from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Lumbar - 1st Week | 3.71 units on a scale | Standard Deviation 2.76 |
| SJet | VAS for Lumbar - 1st Week | 4.1 units on a scale | Standard Deviation 2.93 |
p-value: <0.0595% CI: [-2.21, 1.43]t-test, 2 sided
Secondary
VAS for Lumbar Pain - 12th Month
Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 12th month from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Lumbar Pain - 12th Month | 4.06 units on a scale | Standard Deviation 3.54 |
| SJet | VAS for Lumbar Pain - 12th Month | 3.03 units on a scale | Standard Deviation 3.32 |
p-value: <0.0595% CI: [-1.3, 3.3]t-test, 2 sided
Secondary
VAS for Lumbar Pain - 3rd Month
Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 3rd month from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Lumbar Pain - 3rd Month | 2.63 units on a scale | Standard Deviation 2.9 |
| SJet | VAS for Lumbar Pain - 3rd Month | 4.53 units on a scale | Standard Deviation 3.47 |
Secondary
VAS for Lumbar Pain - 6th Month
Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Time frame: 6th month from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMicro | VAS for Lumbar Pain - 6th Month | 3.5 units on a scale | Standard Deviation 3.54 |
| SJet | VAS for Lumbar Pain - 6th Month | 3.79 units on a scale | Standard Deviation 3.34 |
p-value: <0.0595% CI: [-2.58, 2.01]t-test, 2 sided