SYMPATHY: A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02335216
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

18-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 pain following lumbar discectomy (Failed Back Surgery Syndrome)

Condition or Disease	Intervention/Treatment	Phase
Failed Back Surgery Syndrome	Device: Implantation with the commercially available Axium neurostimulator

Study Design

• Study Type: Observational
• Actual Enrollment: 22 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Post Market ObServational StudY on the Effect of DRG StiMulation in PATients witH Chronic Pain Following Surgical Lumbar DiscectomY (Failed Back Surgery Syndrome): SYMPATHY
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Treated Subjects All subjects recruited and treated with the Axium neurostimulator	Device: Implantation with the commercially available Axium neurostimulator

Outcome Measures

Primary Outcome Measures

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

   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 and 12-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 pain following surgical lumbar discectomy 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 subjects primary area of pain

6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study

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. Subject has an anatomical spinal abnormality which is anticipated to require further surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Antonius Ziekenhuis	Nieuwegein		Netherlands

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02335216
• Other Study ID Numbers: 18-SMI-2013
• First Posted: Jan 9, 2015
• Last Update Posted: Oct 16, 2019
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Syndrome; Failed Back Surgery Syndrome

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	22
Received Trial System	16
Received Permanent System	13
COMPLETED	9
NOT COMPLETED	13

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	22
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	51
Sex: Female, Male (Count of Participants)
Female	13 59.1%
Male	9 40.9%
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	21 95.5%
More than one race	0 0%
Unknown or Not Reported	1 4.5%
Region of Enrollment (Count of Participants)
Netherlands	22 100%

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 and 12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Subjected Treated With the Permanent Implantable Axium System
Arm/Group Description	All subjects treated with the Axium implantable neurostimulator
Measure Participants	13
Baseline	7.7 (1.1)
3-Month Visit	2.9 (3.0)
6-Month Visit	2.6 (3.6)
12-Month Visit	2.4 (2.9)

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 and 12-Month Visits

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Subjected Treated With the Permanent Implantable Axium System
Arm/Group Description	All subjects treated with the Axium implantable neurostimulator
Measure Participants	13
3-Month Visit	9 40.9%
6-Month Visit	8 36.4%
12-Month Visit	7 31.8%

Adverse Events

Time Frame	All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Adverse Event Reporting Description	All-cause mortality was not assessed in this study.
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	0/0 (NaN)
Serious Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	1/22 (4.5%)
Hepatobiliary disorders
Abdominal pain	1/22 (4.5%)	1
Other (Not Including Serious) Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	7/22 (31.8%)
Ear and labyrinth disorders
Buzzing noise in left ear	1/22 (4.5%)	1
Infections and infestations
Wound Infection	2/22 (9.1%)	2
Injury, poisoning and procedural complications
IPG Pocket Pain	1/22 (4.5%)	1
Fall	1/22 (4.5%)	1
Loss of stimulation	1/22 (4.5%)	1
Dural puncture	3/22 (13.6%)	3
Hematoma/Infection	1/22 (4.5%)	1
Nervous system disorders
Irritated ganglion	1/22 (4.5%)	1

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.