Trial Outcomes & Findings for Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis (NCT NCT00995371)

Results Overview

Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

38 participants

Primary outcome timeframe

Baseline and 6 weeks prior to cross-over

Results posted on

2013-11-15

Participant Flow

Patients were enrolled through one site (Coastal Orthopedics) between September 2009 and January 2011.

Randomization occurred in blocks of four. After Week 6 post-treatment and prior to 4 months, ESI arm participants were allowed to cross over to mild if they chose to have it.

Participant milestones

Participant milestones
Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Epidural Steroid Injection Then Lumbar Decompression With Mild Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit
Prior to ESI Cross-over, 6 Weeks STARTED	21	17
Prior to ESI Cross-over, 6 Weeks COMPLETED	21	17
Prior to ESI Cross-over, 6 Weeks NOT COMPLETED	0	0
After ESI Cross-over to Mild, 26 Weeks STARTED	21	17
After ESI Cross-over to Mild, 26 Weeks COMPLETED	16	12
After ESI Cross-over to Mild, 26 Weeks NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Epidural Steroid Injection Then Lumbar Decompression With Mild Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit
After ESI Cross-over to Mild, 26 Weeks Withdrawal by Subject	5	5

Baseline Characteristics

Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n=21 Participants Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Epidural Steroid Injection n=17 Participants Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Age, Categorical >=65 years	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Age Continuous	74.24 years STANDARD_DEVIATION 10.12 • n=93 Participants	78.71 years STANDARD_DEVIATION 7.11 • n=4 Participants	76.26 years STANDARD_DEVIATION 9.18 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	8 Participants n=4 Participants	21 Participants n=27 Participants
Region of Enrollment United States	21 participants n=93 Participants	17 participants n=4 Participants	38 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks prior to cross-over

Population: All 38 participants (21 in mild and 17 in ESI arm) reported VAS at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.

Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.

Outcome measures

Outcome measures
Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n=21 Participants Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Epidural Steroid Injection Prior to Cross-Over n=17 Participants Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
Mean Change in VAS	2.52 units on a scale Interval 1.09 to 3.96	0.06 units on a scale Interval -1.43 to 1.55

PRIMARY outcome

Timeframe: Baseline and 6 weeks prior to cross-over

Population: All 38 participants (21 in mild and 17 in ESI arm) reported ODI at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.

Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value

Outcome measures

Outcome measures
Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n=21 Participants Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Epidural Steroid Injection Prior to Cross-Over n=17 Participants Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
Mean Change in ODI	11.33 units on a scale Interval 3.35 to 19.31	5.65 units on a scale Interval -4.12 to 15.41

PRIMARY outcome

Timeframe: Baseline and 26 weeks After ESI to mild cross-over

Population: Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.

Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.

Outcome measures

Outcome measures
Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n=16 Participants Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Epidural Steroid Injection Prior to Cross-Over n=12 Participants Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
Mean Change in VAS	2.19 units on a scale Interval 0.61 to 3.77	1.00 units on a scale Interval -0.66 to 2.66

PRIMARY outcome

Timeframe: Baseline and 26 weeks After ESI to mild cross-over

Population: Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.

Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value

Outcome measures

Outcome measures
Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n=16 Participants Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Epidural Steroid Injection Prior to Cross-Over n=12 Participants Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
Mean Change in ODI	16.13 units on a scale Interval 7.43 to 24.83	6.17 units on a scale Interval -1.24 to 13.58

Adverse Events

Vertos Mild® Minimally-Invasive Lumbar Decompression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epidural Steroid Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ESI Cross-over to Lumbar Decompression With Mild

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

Lois A. Davis

Coastal Orthopedics & Sports Medicine

Phone: 941-782-1353

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place