Section 15: Lumina Study Flashcards
How many doctors participated in the lumina study, and who was the study in correspondence to?
16, Dr. Veizi @ western reserve university, pain medicine service, Louis stokes, Cleveland VA medical center
Lumina Study title
Spinal cord stimulation with anatomically guided (3D) neural targeting shows SUPERIOR chronic axial low back pain relief compared to traditional SCS
Lumina Study Design and Methods (multi vs single, open vs closed label, what kind of arm, prospective or retrospective)
MULTI center OPEN LABEL OBSERVATIONAL STUDY W/ an Observational (retrospective) arm Prospective Analysis
What was the Lumina Study analyzing?
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
How many patients were trialed in the lumina study with illumina 3D? What was the trial to implant ratio?
213; 86%
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?
7 different configurations; 14.3 (+/- 6.1) contacts was the mean; majority was 24-32 contacts
Which system was the 3D neural targetI got SCS cohort treated within the Lumina Study?
PRECISION SPECTRA SCS SYSTEM
Which system was used for the traditional SCS cohort in the Lumina Study
Precision SCS System
Chronic pain is estimated to affect what percentage of people in the US?
55%
According to the Lumina study, what part of the dorsal column are the accessible neural fibers located? (Particular to the lower thoracic spine)
The lateral dorsal column, near the dorsal roots
In the mid- thoracic spine, what separates the neural fibers that are needed for low back pain coverage from the leads?
CSF (cerebrospinal fluid)
At 24 mo post implant, by how much did regular pain scores reduce by (NRS Score) for regular and severe pain groups?
Regular: NRS improved by 4.2
Severe: improved by 5.3
For axial low back pain, by how much did those patients (regular and severe) score improve by ? (With the 3D neural targeting)
Regular: 4.1
Severe: 5.6
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 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
Sweet spot refers to precision or precision spectra?
Spectra
How many months did the Lumina span over?
24
True or false: the Lumina study used the largest chronic axial low back pain SCS cohort published to date
True
How many centers participated in the Lumina study ?
13, but 11 participated
In the Lumina study, what was the trial success determined by?
The PPR score (percent pain relief) must be 50% or greater
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.
Propensity Score Matching (PSM)
What percentage of data was gathered by the end of the 24 mos?
92%
Mean patient age of Lumina study? Predominant gender? Most common diagnosis? Predominant pain area? Pain severity number?
56.8 years old Female FBSS Low back pain only Overall pain was 7.17 +/- 2.06
What proportion of patients had severe pain scores? Moderate?
51% and 38% had moderate
Where were the majority of the leads placed in the Lumina study?
T8 & T7
Which 3 were the most common lead configurations used?
Two 1x16
Two 1x8
Four 1x8
What was the final number (and %) of patients that moved from trial to implant in the lumina study?
184, 86.4%
For LOWBACK AND LEG PAIN PATIENTS, by how many points did their NRS score reduce by in both overall and severe pain patients?
Overall: 4.23
Severe: 5.34
For AXIAL LOW BACK PAIN PATIENTS, how much did their NRS scores improve by? (Both overall and severe)
Overall: 4.1
Severe: 5.6
Who would a “responder “ be considered to be in the Lumina Study and what percent of patients were responders at 24 mos?
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
Comparing traditional SCS to 3D, what was the ‘responder rate’ for axial back pain patients (50% pain reduction at 24 months) for each?
Traditional: 41%
3D: 71%
1.7 x greater for 3D neural targeting
By how many points did the NRS Scores improve for the traditional SCS cohort? (Overall pain and low back pain)
Overall: 2.97 points
Low back: 1.81 points
For patients with OVERALL pain, what were the responder rates for traditional SCS and 3D patients?
Traditional: 51%
3D: 74%
1.5x greater
For patients with LEG pain, what were the responder rates for traditional SCS and 3D patients?
Traditional: 63%
3D: 81%
How many incidents of complications occurred in the Lumina study? In how many patients? No complication was greater than what % of the cohort?
43 incidents
33 patients
No incident was more than 3.8% of cohort.
True or false : the Lumina study was a randomized control trial.
FALSE, it was an observational study
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.
TRUE
In the Lumina study, what was used to minimize selection bias and ensure comparability between two treatment groups?
Propensity score matching
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?
Precision Spectra Cohort: 213, 184, 169
Precision Plus cohort: 213, 147, 141
What does consecutive patient mean?
One after the other as long as they met product indications, (no cherry picking)
For the illumina 3D cohort, how did overall pain scores change over 2 years?
7.1 to a 2.94
What are the 3 key points of Lumina study?
- The Lumina is PUBLISHED- it is peer reviewed and was determined that it actually matters
- Includes LOW BACK data
- Illumina 3D is 70% more effective in the real world in treating patients with low back pain
What are the pain score improvements for axial low back pain, severe low back, overall pain, and severe overall pain
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
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?
70%
What percent of patients were low back only?
42%
