Trial Outcomes & Findings for Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain (NCT NCT02587637)

NCT ID: NCT02587637

Last Updated: 2024-09-19

Results Overview

The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 6 month follow-up visit as compared to baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	All Subjects Subjects with confirmed discogenic low back pain enrolled in the study
Overall Study STARTED	20
Overall Study Received Intervention	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain

Baseline characteristics by cohort

Measure	All Subjects n=20 Participants Subjects with confirmed discogenic low back pain enrolled in the study
Age, Customized	45 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Netherlands	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 15 patients were implanted with the DRG Axium system.

The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 6 month follow-up visit as compared to baseline.

Outcome measures

Measure	All Subjects n=15 Participants Subjects with confirmed discogenic low back pain enrolled in the study
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months	11 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 15 patients were implanted with the DRG Axium system, 14 patients have available data for pain relief at 12 months.

The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 12 month follow-up visit as compared to baseline.

Outcome measures

Measure	All Subjects n=14 Participants Subjects with confirmed discogenic low back pain enrolled in the study
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months	13 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: 15 patients had available data at 6 Months.

The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted.

Outcome measures

Measure	All Subjects n=15 Participants Subjects with confirmed discogenic low back pain enrolled in the study
Percentage of Patients With Improved Global Impression of Change at 6 Months	10 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: 14 patients had available data at 12 Months.

The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted.

Outcome measures

Measure	All Subjects n=14 Participants Subjects with confirmed discogenic low back pain enrolled in the study
Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System	11 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: 15 patients had available data at 6 Months.

Subjects experiencing 50% or more reduction in the intensity of the back pain.

Outcome measures

Measure	All Subjects n=15 Participants Subjects with confirmed discogenic low back pain enrolled in the study
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months	11 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: 14 patients had available data at 12 Months.

Subjects experiencing 50% or more reduction in the intensity of the back pain.

Outcome measures

Measure	All Subjects n=14 Participants Subjects with confirmed discogenic low back pain enrolled in the study
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months	11 Participants

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Subjects n=20 participants at risk Subjects with confirmed discogenic low back pain enrolled in the study
General disorders Increased Pain	25.0% 5/20 • Number of events 5 • device related AE's and SAE's were reported from Informed Consent signature until the last follow-up visit (12 Months) Only device related AE's and SAE's were reported
Skin and subcutaneous tissue disorders Pain at pocket	15.0% 3/20 • Number of events 3 • device related AE's and SAE's were reported from Informed Consent signature until the last follow-up visit (12 Months) Only device related AE's and SAE's were reported

Additional Information

Robyn Capobianco

Abbott

Phone: +1 512 286 4274

Email: robyn.capobianco@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60