Trial Outcomes & Findings for SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery (NCT NCT04676022)
NCT ID: NCT04676022
Last Updated: 2025-03-06
Results Overview
Proportion of subjects with 50% or greater reduction in overall pain relief
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
3 months post-activation
Results posted on
2025-03-06
Participant Flow
241 subjects provided informed consent.
After subjects were consented and enrolled, they were evaluated per study eligibility criteria. Only those who met criteria proceeded to randomization.
Participant milestones
| Measure |
Spinal Cord Stimulation
Randomized to receive Spinal Cord Stimulation programming
WaveWriter: To receive Spinal Cord Stimulation programming
|
Conventional Medical Management
Randomized to receive conventional medical management
Conventional Medical Managament: To receive conventional medical management
|
Non-randomized Subjects
Consented subjects who were not randomized in the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
79
|
68
|
94
|
|
Overall Study
COMPLETED
|
57
|
64
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
4
|
94
|
Reasons for withdrawal
| Measure |
Spinal Cord Stimulation
Randomized to receive Spinal Cord Stimulation programming
WaveWriter: To receive Spinal Cord Stimulation programming
|
Conventional Medical Management
Randomized to receive conventional medical management
Conventional Medical Managament: To receive conventional medical management
|
Non-randomized Subjects
Consented subjects who were not randomized in the study.
|
|---|---|---|---|
|
Overall Study
Screen Failure/
|
1
|
1
|
85
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
6
|
|
Overall Study
Will not move forward with permanent implant
|
6
|
0
|
0
|
|
Overall Study
Various reasons (moved, no longer meets criteria, visit not done etc.)
|
7
|
1
|
1
|
Baseline Characteristics
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
Baseline characteristics by cohort
| Measure |
Randomized to Spinal Cord Stimulation (SCS) Treatment Activated
n=79 Participants
Baseline demographics and clinical characteristics for subjects in the SCS arm
|
Randomized to Conventional Medical Management (CMM) Treatment Activated
n=68 Participants
Baseline demographics and clinical characteristics for subjects in the CMM arm
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 12.10 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : American Indian or Alaska native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : Black, of African heritage
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : Caucasian
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : Not disclosed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity : Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=5 Participants
|
68 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
Duration of Low Back Pain
|
11.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
12.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
12.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Average low back pain (VRS)
|
7.5 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 0.9 • n=7 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Average overall pain (VRS)
|
7.5 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Oswestry Disability Index (ODI) Summary Score
|
54.4 units on a scale
STANDARD_DEVIATION 8.5 • n=5 Participants
|
54.4 units on a scale
STANDARD_DEVIATION 9.4 • n=7 Participants
|
54.4 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post-activationPopulation: Intent to Treat population
Proportion of subjects with 50% or greater reduction in overall pain relief
Outcome measures
| Measure |
Spinal Cord Stimulation
n=57 Participants
To receive Spinal Cord Stimulation programming
WaveWriter: To receive Spinal Cord Stimulation programming
|
Conventional Medical Management
n=62 Participants
To receive conventional medical management
Conventional Medical Managament: To receive conventional medical management
|
|---|---|---|
|
Responder Rate
|
51 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3-Months post activationPopulation: Intent to treat population
Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=57 Participants
To receive Spinal Cord Stimulation programming
WaveWriter: To receive Spinal Cord Stimulation programming
|
Conventional Medical Management
n=64 Participants
To receive conventional medical management
Conventional Medical Managament: To receive conventional medical management
|
|---|---|---|
|
Change in Disability (Oswestry Disability Index)
|
-27.5 score on a scale
Standard Deviation 15.9
|
-7.2 score on a scale
Standard Deviation 9.9
|
Adverse Events
Randomized to SCS
Serious events: 8 serious events
Other events: 9 other events
Deaths: 0 deaths
Randomized to CMM
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Randomized to SCS
n=79 participants at risk
Subjects Randomized to SCS Arm through 3 Months post-Activation.
|
Randomized to CMM
n=68 participants at risk
Subjects Randomized to CMM Arm through 3 Months post-Activation.
|
|---|---|---|
|
Gastrointestinal disorders
Hiatus hernia
|
1.3%
1/79 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
1.3%
1/79 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/79 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.3%
1/79 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/79 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
1.5%
1/68 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Renal and urinary disorders
Renal Mass
|
1.3%
1/79 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Psychiatric disorders
Alcohol Use Disorder
|
1.3%
1/79 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.3%
1/79 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
1/79 • Number of events 1 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
Other adverse events
| Measure |
Randomized to SCS
n=79 participants at risk
Subjects Randomized to SCS Arm through 3 Months post-Activation.
|
Randomized to CMM
n=68 participants at risk
Subjects Randomized to CMM Arm through 3 Months post-Activation.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
3/79 • Number of events 3 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
5.9%
4/68 • Number of events 4 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.8%
3/79 • Number of events 3 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.8%
3/79 • Number of events 3 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
0.00%
0/68 • Randomized subjects through 3-Months post-Activation, an average of 6 months.
|
Additional Information
Sr. Director, Clinical Operations
Boston Scientific Corporation
Phone: 855-213-9890
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER