A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02335229
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 44.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

20-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical pain

Condition or Disease	Intervention/Treatment	Phase
Chronic Post Surgical Pain	Device: Axium DRG Neurostimulator

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Post Market Observational Cohort Study to Assess the Performance of the Spinal Modulation Dorsal Root Ganglion Stimulator System for the Management of Chronic Post Surgical Pain
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Axium DRG Neurostimulator All eligible subjects recruited and treated with the Axium Neurostimulator	Device: Axium DRG Neurostimulator; Implantation with Axium DRG Neurostimulator

Outcome Measures

Primary Outcome Measures

1. Change in Pain Intensity for Overall Pain From Pre-treatment Baseline [Baseline, 3, 6, 12 and 24-Month Visits]

   The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).

2. Percentage of Subjects With at Least 50% Pain Reduction [3, 6, 12 and 24-Month Visits]

   Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is at least 18 years old

2. Subject is able and willing to comply with the follow-up schedule and protocol

3. Chronic post surgical pain for at least 6 months

4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain

5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain

6. Subject is able to provide written informed consent

7. Pain medication dosage has been stable for at least 30 days

8. Patient has been included for implantation according to standard criteria from the Dutch Neuromodulation Society

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control

2. Escalating or changing pain condition within the past month as evidenced by investigator examination

3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days

4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months

5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump

6. Subject is unable to operate the device

7. Subjects with indwelling devices that may pose an increased risk of infection

8. Subjects currently has an active infection

9. Subject has participated in another clinical investigation within 30 days

10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation

11. Subject has been diagnosed with cancer in the past 2 years.

12. Patient has no other exclusion criteria according to standard criteria from the Dutch Neuromodulation Society

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academisch Medisch Centrum	Amsterdam		Netherlands

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 24, 2013

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02335229
• Other Study ID Numbers: 20-SMI-2013
• First Posted: Jan 9, 2015
• Last Update Posted: Apr 29, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Period Title: Overall Study
STARTED	30
Received Trial System	10
Received Permanent System	26
COMPLETED	23
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Overall Participants	30
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	50
Sex: Female, Male (Count of Participants)
Female	13 43.3%
Male	17 56.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	30 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Netherlands	30 100%

Outcome Measures

1. Primary Outcome

Title	Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
Description	The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).
Time Frame	Baseline, 3, 6, 12 and 24-Month Visits

Outcome Measure Data

Analysis Population Description

Differences in participants over time is due to early withdrawals and missing data

Arm/Group Title	Subjects Treated With the Permanent Implantable Axium System
Arm/Group Description	All subjects treated with the Axium implantable neurostimulator
Measure Participants	30
Baseline	6.7 (2.0)
3-Month Visit	5.2 (2.5)
6-Month Visit	3.9 (2.7)
12-Month Visit	4.8 (2.6)
24-Month Visit	4.8 (2.0)

2. Primary Outcome

Title	Percentage of Subjects With at Least 50% Pain Reduction
Description	Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).
Time Frame	3, 6, 12 and 24-Month Visits

Outcome Measure Data

Analysis Population Description

Differences in participants over time is due to early withdrawals and missing data

Arm/Group Title	Subjects Treated With the Permanent Implantable Axium System
Arm/Group Description	All subjects treated with the Axium implantable neurostimulator
Measure Participants	30
3-Month Visit	6 20%
6-Month Visit	5 16.7%
12-Month Visit	5 16.7%
24-Month Visit	6 20%

Adverse Events

Time Frame	Adverse events were collected from Informed Consent through study exit (24-Month visit).
Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
All Cause Mortality
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	4/30 (13.3%)
Injury, poisoning and procedural complications
Lead damaged due to accidental incision	1/30 (3.3%)	1
Investigations
Low blood sodium level	1/30 (3.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant tumor	1/30 (3.3%)	1
Product Issues
Increasing pain due to lead failure/malfunction	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	8/30 (26.7%)
General disorders
Pain at IPG Pocket	3/30 (10%)	3
Increased pain in the target area	1/30 (3.3%)	1
Injury, poisoning and procedural complications
Dura Puncture	1/30 (3.3%)	1
Foot injury	1/30 (3.3%)	1
Spinal Tap	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
Back pain	2/30 (6.7%)	2
Shoulder pain	1/30 (3.3%)	1
Nervous system disorders
Kicking movement during the night	1/30 (3.3%)	1
Product Issues
Broken lead	1/30 (3.3%)	1
IPG migration	1/30 (3.3%)	1
Lead migration	2/30 (6.7%)	2
Partial loss of stimulation and pain at IPG pocket	1/30 (3.3%)	1
Loss of stimulation	2/30 (6.7%)	2
Vascular disorders
Bleeding/Hematoma	4/30 (13.3%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.