Trial Outcomes & Findings for Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis (NCT NCT01129921)

Results Overview

Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Week 6 to 12 prior to cross-over

Results posted on

2013-07-16

Participant Flow

Recruitment occurred 4-19-10 to 7-28-10

Randomization occurred in blocks of four. After Week 6 post-treatment and prior to Week 12, Sham arm participants were allowed to have the mild decompression procedure with bone and tissue removal if they chose to have it.

Participant milestones

Participant milestones
Measure	Percutaneous Decompression Procedure Only Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit	Sham Then Percutaneous Decompression With Mild Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
Prior to Sham Cross-over, 6-12 Weeks STARTED	20	20
Prior to Sham Cross-over, 6-12 Weeks COMPLETED	20	20
Prior to Sham Cross-over, 6-12 Weeks NOT COMPLETED	0	0
After Sham Cross-over to Mild, One Year STARTED	20	20
After Sham Cross-over to Mild, One Year COMPLETED	18	13
After Sham Cross-over to Mild, One Year NOT COMPLETED	2	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Percutaneous Decompression Procedure Only Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit	Sham Then Percutaneous Decompression With Mild Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
After Sham Cross-over to Mild, One Year Lost to Follow-up	2	1
After Sham Cross-over to Mild, One Year Lack of Efficacy	0	1
After Sham Cross-over to Mild, One Year Withdrawal by Subject	0	4
After Sham Cross-over to Mild, One Year pancreatic cancer progressed	0	1

Baseline Characteristics

Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mild Procedure n=20 Participants Group 1: mild percutaneous decompression with removal of bone and tissue	Sham Procedure n=20 Participants Group 2: sham decompression with trocar placement and no bone or tissue removal	Total n=40 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	7 Participants n=93 Participants	8 Participants n=4 Participants	15 Participants n=27 Participants
Age, Categorical >=65 years	13 Participants n=93 Participants	12 Participants n=4 Participants	25 Participants n=27 Participants
Age Continuous	66.3 years STANDARD_DEVIATION 10.8 • n=93 Participants	67 years STANDARD_DEVIATION 12.5 • n=4 Participants	66.6 years STANDARD_DEVIATION 11.5 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	7 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	13 Participants n=4 Participants	23 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	20 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: Week 6 to 12 prior to cross-over

Population: All 40 participants (20 in each arm) reported VAS at six weeks to twelve weeks post-treatment. All measurements for the sham group occurred prior to cross-over to the mild procedure. Patients with scores of 4 or less in each study group are reported below. This is Intent to Treat (ITT)analysis.

Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.

Outcome measures

Outcome measures
Measure	Mild Procedure Group 1 n=20 Participants Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.	Sham Procedure Group 2 Prior to Cross-over n=20 Participants Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
Visual Analog Scale (VAS) <=4	11 participants 2.1	2 participants 1.8

PRIMARY outcome

Timeframe: Week 6 to 12 & Year One After Sham to mild x-over

Population: Patients who reported Year 1 outcomes are reported at Week 6-12 and at Year 1. All findings reported below for the Sham group are after cross-over to mild.

VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below.

Outcome measures

Outcome measures
Measure	Mild Procedure Group 1 n=18 Participants Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.	Sham Procedure Group 2 Prior to Cross-over n=13 Participants Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
Visual Analog Scale (VAS) <=4 Week 6-12	9 participants	5 participants
Visual Analog Scale (VAS) <=4 Year 1	12 participants	5 participants

PRIMARY outcome

Timeframe: Baseline and Year 1

Population: All patients who reported Year-1 outcomes (Year-1 Cohort) were analyzed. The Sham Year-1 cohort represent those original Sham patients who crossed over from Sham to the mild procedure and were then followed for one year.

VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.

Outcome measures

Outcome measures
Measure	Mild Procedure Group 1 n=18 Participants Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.	Sham Procedure Group 2 Prior to Cross-over n=13 Participants Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
Visual Analog Scale (VAS) Mean Improvement	2.3 units on a scale Standard Deviation 2.1	2.2 units on a scale Standard Deviation 2.9

Adverse Events

Mild Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Procedure With Optional Crossover to Mild Post-unblinding

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

Eric Grigsby, MD

Napa Pain Institute

Phone: 707-252-9660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place