Trial Outcomes & Findings for Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain (NCT NCT01263054)
NCT ID: NCT01263054
Last Updated: 2018-07-10
Results Overview
Visual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
COMPLETED
NA
67 participants
Baseline and 6 months
2018-07-10
Participant Flow
In this study, 67 subjects were randomized, with 63/67 being treated. Three of the non-treated subjects had exclusion criteria violations, while the fourth subject was not treated for an undisclosed reason. The disposition of subjects in the Participant Flow summary is with respect to the primary outcome.
Participant milestones
| Measure |
TransDiscal System
Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
|
Medical Management
Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
34
|
|
Overall Study
COMPLETED
|
24
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
TransDiscal System
Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
|
Medical Management
Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Qualification Violation
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain
Baseline characteristics by cohort
| Measure |
TransDiscal System
n=29 Participants
Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
|
Medical Management
n=34 Participants
Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 11 • n=5 Participants
|
43 years
STANDARD_DEVIATION 11 • n=7 Participants
|
42 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
34 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Five subjects in the TransDiscal System study arm, and six subjects in the Medical Management study arm did not provide follow-up data.
Visual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Outcome measures
| Measure |
TransDiscal System
n=24 Participants
Kimberly-Clark TransDiscal System in addition to standard medical management
|
Medical Management
n=28 Participants
Standard Medical Management
|
|---|---|---|
|
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.
|
-2.4 units on a scale
Standard Deviation 2.8
|
-0.56 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsVisual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Outcome measures
| Measure |
TransDiscal System
n=29 Participants
Kimberly-Clark TransDiscal System in addition to standard medical management
|
Medical Management
n=34 Participants
Standard Medical Management
|
|---|---|---|
|
Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.
|
50 percentage of study group
|
18 percentage of study group
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.
Short Form 36-PF - score range = 0 - 100. "0" corresponds to "greatest disability" and "100" indicates "no disability". The means of these scores and their respective standard deviations are reported for each study group.
Outcome measures
| Measure |
TransDiscal System
n=24 Participants
Kimberly-Clark TransDiscal System in addition to standard medical management
|
Medical Management
n=27 Participants
Standard Medical Management
|
|---|---|---|
|
Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit
|
18 units on a scale
Standard Deviation 23
|
1.7 units on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.
EQ-5d VAS - score range = 0 - 100. "0" corresponds to the "worst imaginable health state" and "100" indicates the "best imaginable health state". The means of these scores and their respective standard deviations are reported for each study group.
Outcome measures
| Measure |
TransDiscal System
n=24 Participants
Kimberly-Clark TransDiscal System in addition to standard medical management
|
Medical Management
n=27 Participants
Standard Medical Management
|
|---|---|---|
|
Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit
|
15 units on a scale
Standard Deviation 42
|
6 units on a scale
Standard Deviation 31
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Five subjects in the TransDiscal System study arm, and eight subjects in the Medical Management study arm did not provide follow-up data.
BDI - score range = 0 - 63. "0" corresponds to "minimal depression" and "63" indicates "severe depression". The means of these scores and their respective standard deviations are reported for each study group.
Outcome measures
| Measure |
TransDiscal System
n=24 Participants
Kimberly-Clark TransDiscal System in addition to standard medical management
|
Medical Management
n=26 Participants
Standard Medical Management
|
|---|---|---|
|
Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit
|
0.39 units on a scale
Standard Deviation 8
|
-0.23 units on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Six subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.
PGIC - score range = 1 - 7. "1" corresponds to "very much improved" and "7" indicates "very much worse" pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group.
Outcome measures
| Measure |
TransDiscal System
n=23 Participants
Kimberly-Clark TransDiscal System in addition to standard medical management
|
Medical Management
n=27 Participants
Standard Medical Management
|
|---|---|---|
|
Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit
|
-1.7 units on a scale
Standard Error 1.6
|
0.3 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.
ODI - score range = 0 - 100. "0" corresponds to "no disability" and "100" indicates the "maximum disability possible". The means of these scores and their respective standard deviations are reported for each study group.
Outcome measures
| Measure |
TransDiscal System
n=24 Participants
Kimberly-Clark TransDiscal System in addition to standard medical management
|
Medical Management
n=27 Participants
Standard Medical Management
|
|---|---|---|
|
Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit
|
-11 units on a scale
Standard Deviation 17
|
0.22 units on a scale
Standard Deviation 7
|
Adverse Events
TransDiscal System
Medical Management
Serious adverse events
| Measure |
TransDiscal System
n=29 participants at risk
Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
|
Medical Management
n=34 participants at risk
Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes.
|
|---|---|---|
|
Gastrointestinal disorders
pancreatitis
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
abdominal pain upper
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Psychiatric disorders
completed suicide
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Vascular disorders
iliac artery occlusion
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
General disorders
chest pain
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
Other adverse events
| Measure |
TransDiscal System
n=29 participants at risk
Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
|
Medical Management
n=34 participants at risk
Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes.
|
|---|---|---|
|
Ear and labyrinth disorders
vertigo
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
constipation
|
6.9%
2/29 • Number of events 2
|
0.00%
0/34
|
|
General disorders
discomfort
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
General disorders
fatigue
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
General disorders
inflammation
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
General disorders
pain
|
10.3%
3/29 • Number of events 3
|
8.8%
3/34 • Number of events 3
|
|
General disorders
swelling
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Immune system disorders
seasonal allergy
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
diverticulitis
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
nasopharyngitis
|
3.4%
1/29 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
sinusitis
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
upper respiratory tract infection
|
10.3%
3/29 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
herpes zoster
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
influenza
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
foot fracture
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Injury, poisoning and procedural complications
accident
|
6.9%
2/29 • Number of events 2
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
fall
|
3.4%
1/29 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Injury, poisoning and procedural complications
head injury
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Injury, poisoning and procedural complications
road traffic accident
|
3.4%
1/29 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
3.4%
1/29 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
sacroiliitis
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
3.4%
1/29 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
foot deformity
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc displacement
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
24.1%
7/29 • Number of events 7
|
26.5%
9/34 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
3.4%
1/29 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal stiffness
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
plantar fasciitis
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
bunion
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
headache
|
3.4%
1/29 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
migraine
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
dizziness postural
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Nervous system disorders
parathesia
|
6.9%
2/29 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
sciatica
|
3.4%
1/29 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Psychiatric disorders
depression
|
6.9%
2/29 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Psychiatric disorders
insomnia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/34
|
|
Renal and urinary disorders
loss of bladder sensation
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Renal and urinary disorders
pollakiuria
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
thrombophlebitis
|
0.00%
0/29
|
2.9%
1/34 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place