Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome
Study Details
Study Description
Brief Summary
Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are associated with impairment in mood, social and physical function. Spinal Cord Stimulation (SCS), a technique of placing electrodes into the epidural space is a validated treatment for Complex Regional Pain Syndrome . Treatment of CRPS with SCS, in combination with physical therapy, reduced pain to a greater degree than physical therapy alone. 40%-50% of CRPS patients achieve >50% pain relief with SCS using dorsal column stimulation . Dorsal Root Ganglion (DRG) SCS has also recently demonstrated clinical efficacy in patients with CRPS and peripheral causalgia . The hypothesis is that DRG stimulation is non-inferior to dorsal column SCS in patients with CRPS who have failed to respond to a course of analgesics and physical therapy. The aim to assess functional, quality of life, patient satisfaction and medication requirements in subjects treated with neuromodulation for CRPS and contrast outcomes amongst subjects treated with DRG SCS and dorsal column SCS.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The purpose of this study is to compare outcomes between dorsal column spinal cord stimulation and dorsal root ganglion spinal cord stimulation in patients with Complex Regional Pain Syndrome at an infraumbilical location who have failed a course of conservative management including analgesic pharmacotherapy and physical therapy.
This is a prospective randomized post-marketing clinical study. Patients will be randomized in a 1:1 ratio to Dorsal Column or Dorsal Root Ganglion Spinal Cord Stimulation if they have failed a course of conservative management including analgesics and physical therapy. All patients are expected to undergo clinical, neurological, and imaging assessments, if appropriate, at selected follow-up visits.
The study will be conducted a single center with a target maximum of 62 patients (31 randomized to each group).
Enrollment of subjects in this study is anticipated to take 24 months. Clinical follow-up evaluations will be conducted at 10 days, 1, 3 and 6 months post-implant. The total study duration is expected to be at least 30 months.
All patients presenting to the Investigators with Budapest criteria, research subset , for the diagnosis of Complex Regional Pain Syndrome at an infraumbilical location who have not had an adequate response to a course of conservative management including analgesics and physical therapy will be screened for eligibility. A Screening/Enrollment Log will be utilized in order to maintain a cumulative tracking of all screened patients.
Patients must meet all inclusion/exclusion criteria for enrollment in the clinical study. Reasons for screening failure(s) will be documented.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Dorsal Column Stimulation Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator |
Device: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
| Dorsal Root Ganglion Stimulation Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System |
Device: The Axium Neurostimulator System
The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II
|
Outcome Measures
Primary Outcome Measures
- Change in Numerical Rating Scale for Pain Intensity [6 Months]
To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point [0-10] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable.
Secondary Outcome Measures
- Change in Oswestry Disability Index for Pain Intensity [6 Month]
To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy in function based on Oswestry Disability Index (ODI) for functional impairment. A score of 0 on the 101-point [0-100] Oswestry Disability Index indicates no disability while 100 indicates bed-bound.
Other Outcome Measures
- Change in European Quality of Life 5 Dimension Scale [6 Months]
Change in Quality of Life as measured by the European Quality of Life 5 Dimension (EQ-5D) Scale. The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.
- Health Status Measured by Short Form-36 (SF-36) [6 Months]
Change in Health Status measured by Short Form-36 (SF-36). This form measures patient's overall health. Scores range from 0 - 100 with lower scores indicating more disability while higher scores indicate less disability.
- Pain Medication Usage [6 Months]
The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as the main indicator for analgesic potency. Oral morphine equivalents are based on the idea that different doses of different opioids may give a similar analgesic effect. Where the doses of two different opioids are considered to give a comparable analgesic effect, they are deemed to be equianalgesic doses.
- Satisfaction With the Pain Relief [6 Months]
There will be 3 separate questions on the form. Subjects will be asked to rate their satisfaction with the pain relief, satisfaction with the therapy in general and their likelihood undergoing the therapy again for a similar outcome as a percentage from 0-100% with 0% indicating no satisfaction/likelihood and 100% indicating completely satisfied and 100% likelihood of undergoing the therapy again for a similar outcome.
- Adverse Events Related to the Procedure or Devices [6 Months]
Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated.
- Patients' Global Impression of Change (PGIC) [6 Months]
Patients will be asked to rate their overall change in quality of health on a scale of 1 to 7 with 1 being no change in overall health and 7 being a great deal better in comparison to before implant. Another scale will on the same form ranging from 0-10 with 0 being much better, 5 being no change and 10 being much worse.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
• Patient is greater than18 years of age
-
An infraumbilical location of the index pain
-
Symptoms have been present for greater than 6 months
-
Continuing pain which is disproportionate to any inciting event
-
Report hyperesthesia and/or allodynia
-
Report vasomotor changes including temperature asymmetry and/or skin color changes and/or skin color asymmetry
-
Report edema and/or sweating changes and/or sweating asymmetry
-
Report decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
-
Display at least one sign in two or more of the following categories:
-
Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or temperature sensation and/or deep somatic pressure and/or joint movement)
-
Vasomotor: Evidence of temperature asymmetry (>1°C) and/or skin color changes and/or asymmetry
-
Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry
-
Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
-
Patient failed to have resolution of symptoms despite at least 4 weeks of conservative management including analgesic pharmacotherapy and physical therapy
-
Patient has index site pain > spine pain
-
The subject is physically and mentally able to participate in the study
-
Patient is willing and able to provide informed consent
-
Patient is willing and able to comply with the study protocol
Exclusion Criteria:
-
Previous surgery to the spine which could compromise placement of the study device
-
Anatomical spinal abnormality including severe central canal stenosis or bony foraminal impingement which could preclude device placement
-
Foreseen need for MRI to monitor or evaluate another chronic condition
-
Previous experience with an implanted or trial neuromodulation system (spinal cord stimulation, peripheral nerve stimulation) for the treatment of pain at the index location
-
Active local or systemic infection
-
Actively in litigation for pain symptoms
-
Currently on Workman's Compensation
-
Women who are pregnant or intend to become pregnant during the study duration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roberta Johnson | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Robert Bolash, MD, The Cleveland Clinic
Study Documents (Full-Text)
More Information
Publications
None provided.- 18-1115
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Period Title: Overall Study | ||
| STARTED | 1 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation | Total |
|---|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II | Total of all reporting groups |
| Overall Participants | 1 | 0 | 1 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
NaN
|
|
| Between 18 and 65 years |
1
100%
|
1
Infinity
|
|
| >=65 years |
0
0%
|
0
NaN
|
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
100%
|
1
Infinity
|
|
| Male |
0
0%
|
0
NaN
|
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
NaN
|
|
| Not Hispanic or Latino |
1
100%
|
1
Infinity
|
|
| Unknown or Not Reported |
0
0%
|
0
NaN
|
|
| Region of Enrollment (participants) [Number] | |||
| United States |
1
100%
|
1
Infinity
|
|
Outcome Measures
| Title | Change in Numerical Rating Scale for Pain Intensity |
|---|---|
| Description | To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point [0-10] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| No patients achieved the 6 month endpoint |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Measure Participants | 0 | 0 |
| Title | Change in Oswestry Disability Index for Pain Intensity |
|---|---|
| Description | To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy in function based on Oswestry Disability Index (ODI) for functional impairment. A score of 0 on the 101-point [0-100] Oswestry Disability Index indicates no disability while 100 indicates bed-bound. |
| Time Frame | 6 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Measure Participants | 0 | 0 |
| Title | Change in European Quality of Life 5 Dimension Scale |
|---|---|
| Description | Change in Quality of Life as measured by the European Quality of Life 5 Dimension (EQ-5D) Scale. The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Measure Participants | 0 | 0 |
| Title | Health Status Measured by Short Form-36 (SF-36) |
|---|---|
| Description | Change in Health Status measured by Short Form-36 (SF-36). This form measures patient's overall health. Scores range from 0 - 100 with lower scores indicating more disability while higher scores indicate less disability. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Measure Participants | 0 | 0 |
| Title | Pain Medication Usage |
|---|---|
| Description | The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as the main indicator for analgesic potency. Oral morphine equivalents are based on the idea that different doses of different opioids may give a similar analgesic effect. Where the doses of two different opioids are considered to give a comparable analgesic effect, they are deemed to be equianalgesic doses. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Measure Participants | 0 | 0 |
| Title | Satisfaction With the Pain Relief |
|---|---|
| Description | There will be 3 separate questions on the form. Subjects will be asked to rate their satisfaction with the pain relief, satisfaction with the therapy in general and their likelihood undergoing the therapy again for a similar outcome as a percentage from 0-100% with 0% indicating no satisfaction/likelihood and 100% indicating completely satisfied and 100% likelihood of undergoing the therapy again for a similar outcome. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Measure Participants | 0 | 0 |
| Title | Adverse Events Related to the Procedure or Devices |
|---|---|
| Description | Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Measure Participants | 0 | 0 |
| Title | Patients' Global Impression of Change (PGIC) |
|---|---|
| Description | Patients will be asked to rate their overall change in quality of health on a scale of 1 to 7 with 1 being no change in overall health and 7 being a great deal better in comparison to before implant. Another scale will on the same form ranging from 0-10 with 0 being much better, 5 being no change and 10 being much worse. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected |
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation |
|---|---|---|
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The definitions parallel those listed on clinicaltrials.gov | |||
| Arm/Group Title | Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation | ||
| Arm/Group Description | Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. | Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II | ||
All Cause Mortality |
||||
| Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/0 (NaN) | ||
Serious Adverse Events |
||||
| Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Dorsal Column Stimulation | Dorsal Root Ganglion Stimulation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Robert Bolash |
|---|---|
| Organization | Cleveland Clinic |
| Phone | 216-444-3134 |
| bolashr@ccf.org |
- 18-1115