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BSN Phase 1 > Section 15: Lumina Study > Flashcards

Section 15: Lumina Study Flashcards

1
Q

How many doctors participated in the lumina study, and who was the study in correspondence to?

A

16, Dr. Veizi @ western reserve university, pain medicine service, Louis stokes, Cleveland VA medical center

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2
Q

Lumina Study title

A

Spinal cord stimulation with anatomically guided (3D) neural targeting shows SUPERIOR chronic axial low back pain relief compared to traditional SCS

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3
Q

Lumina Study Design and Methods (multi vs single, open vs closed label, what kind of arm, prospective or retrospective)

A 
MULTI center
OPEN LABEL
OBSERVATIONAL STUDY
W/ an Observational (retrospective) arm
Prospective Analysis
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4
Q

What was the Lumina Study analyzing?

A

Whether illumina 3D (neural targeting) or the previous generation software (traditional SCS was more effective in providing pain relief for axial low back pain and overall pain

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5
Q

How many patients were trialed in the lumina study with illumina 3D? What was the trial to implant ratio?

A

213; 86%

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6
Q

How many different lead configurations were used? What was the mean parameter of number of contacts per lead? What was the majority (62%) number of contacts used?

A

7 different configurations; 14.3 (+/- 6.1) contacts was the mean; majority was 24-32 contacts

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7
Q

Which system was the 3D neural targetI got SCS cohort treated within the Lumina Study?

A

PRECISION SPECTRA SCS SYSTEM

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8
Q

Which system was used for the traditional SCS cohort in the Lumina Study

A

Precision SCS System

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9
Q

Chronic pain is estimated to affect what percentage of people in the US?

A

55%

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10
Q

According to the Lumina study, what part of the dorsal column are the accessible neural fibers located? (Particular to the lower thoracic spine)

A

The lateral dorsal column, near the dorsal roots

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11
Q

In the mid- thoracic spine, what separates the neural fibers that are needed for low back pain coverage from the leads?

A

CSF (cerebrospinal fluid)

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12
Q

At 24 mo post implant, by how much did regular pain scores reduce by (NRS Score) for regular and severe pain groups?

A

Regular: NRS improved by 4.2
Severe: improved by 5.3

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13
Q

For axial low back pain, by how much did those patients (regular and severe) score improve by ? (With the 3D neural targeting)

A

Regular: 4.1
Severe: 5.6

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14
Q

When finding coverage, what did the old precision system rely on to target the pain areas? Vs what does the new precision spectra use?

A

A trial and error method of turning the the contacts on and off; now, precision spectra uses an algorithm that takes into account: the electrical conductivity of spinal column structures- dorsal CSF depth, relative lead location, and veterbral level of leads

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15
Q

Sweet spot refers to precision or precision spectra?

A

Spectra

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16
Q

How many months did the Lumina span over?

A

24

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17
Q

True or false: the Lumina study used the largest chronic axial low back pain SCS cohort published to date

A

True

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18
Q

How many centers participated in the Lumina study ?

A

13, but 11 participated

19
Q

In the Lumina study, what was the trial success determined by?

A

The PPR score (percent pain relief) must be 50% or greater

20
Q

This is a statistical matching technique for unbiased comparison of a treatment effect estimate between two groups of patients in a non randomized study by accounting for the covariates that predict whether the treatment was received instead of randomizing patients to treatment or control.

A

Propensity Score Matching (PSM)

21
Q

What percentage of data was gathered by the end of the 24 mos?

A

92%

22
Q 
Mean patient age of Lumina study?
Predominant gender?
Most common diagnosis?
Predominant pain area?
Pain severity number?
A 
56.8 years old
Female
FBSS
Low back pain only
Overall pain was 7.17 +/- 2.06
23
Q

What proportion of patients had severe pain scores? Moderate?

A

51% and 38% had moderate

24
Q

Where were the majority of the leads placed in the Lumina study?

A

T8 & T7

25
Q

Which 3 were the most common lead configurations used?

A

Two 1x16
Two 1x8
Four 1x8

26
Q

What was the final number (and %) of patients that moved from trial to implant in the lumina study?

A

184, 86.4%

27
Q

For LOWBACK AND LEG PAIN PATIENTS, by how many points did their NRS score reduce by in both overall and severe pain patients?

A

Overall: 4.23
Severe: 5.34

28
Q

For AXIAL LOW BACK PAIN PATIENTS, how much did their NRS scores improve by? (Both overall and severe)

A

Overall: 4.1
Severe: 5.6

29
Q

Who would a “responder “ be considered to be in the Lumina Study and what percent of patients were responders at 24 mos?

A

A responder is a patient with 50% or greater pain reduction from baseline in a numeric rating scale pain score. 74% had greater than 50% pain reduction by the end of 24 months

30
Q

Comparing traditional SCS to 3D, what was the ‘responder rate’ for axial back pain patients (50% pain reduction at 24 months) for each?

A

Traditional: 41%
3D: 71%
1.7 x greater for 3D neural targeting

31
Q

By how many points did the NRS Scores improve for the traditional SCS cohort? (Overall pain and low back pain)

A

Overall: 2.97 points

Low back: 1.81 points

32
Q

For patients with OVERALL pain, what were the responder rates for traditional SCS and 3D patients?

A

Traditional: 51%
3D: 74%
1.5x greater

33
Q

For patients with LEG pain, what were the responder rates for traditional SCS and 3D patients?

A

Traditional: 63%
3D: 81%

34
Q

How many incidents of complications occurred in the Lumina study? In how many patients? No complication was greater than what % of the cohort?

A

43 incidents
33 patients
No incident was more than 3.8% of cohort.

35
Q

True or false : the Lumina study was a randomized control trial.

A

FALSE, it was an observational study

36
Q

True or false: the Lumina study was able to single out a large cohort axial low back pain patients compared to other SCS studies who used patients with low back Ian associated with a radical component.

A

TRUE

37
Q

In the Lumina study, what was used to minimize selection bias and ensure comparability between two treatment groups?

A

Propensity score matching

38
Q

What were the two cohorts? How many were trialed in each cohort, how many were implanted? How many made it to the 24 month FU?

A

Precision Spectra Cohort: 213, 184, 169

Precision Plus cohort: 213, 147, 141

39
Q

What does consecutive patient mean?

A

One after the other as long as they met product indications, (no cherry picking)

40
Q

For the illumina 3D cohort, how did overall pain scores change over 2 years?

A

7.1 to a 2.94

41
Q

What are the 3 key points of Lumina study?

A
  1. The Lumina is PUBLISHED- it is peer reviewed and was determined that it actually matters
  2. Includes LOW BACK data
  3. Illumina 3D is 70% more effective in the real world in treating patients with low back pain
42
Q

What are the pain score improvements for axial low back pain, severe low back, overall pain, and severe overall pain

A

Overall pain reduction was Greater than 4
Severe overall pain reduction Greater than 5
Axial low back greater than 4
Axial low back severe greater than 5

43
Q

What is the RELATIVE percentage increase in responder rates for patient with low back only pain?

Lament terms> how much more effective is precision spectra in treating low back pain than precision plus?

A

70%

44
Q

What percent of patients were low back only?

A

42%

BSN Phase 1 (24 decks)

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