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Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794024
Recruitment Status : Terminated (Manufacturer of the device filed for bankruptcy)
First Posted : January 4, 2019
Results First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Bolash, The Cleveland Clinic

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Complex Regional Pain Syndrome
Interventions Device: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator
Device: The Axium Neurostimulator System
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dorsal Column Stimulation Dorsal Root Ganglion Stimulation
Hide 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
Arm/Group Title Dorsal Column Stimulation Dorsal Root Ganglion Stimulation Total
Hide 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 Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
No patients enrolled were randomized into the Dorsal Root Ganglion Stimulation arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
>=65 years
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
1
 100.0%
1
 100.0%
Male
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Change in Numerical Rating Scale for Pain Intensity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No patients achieved the 6 month endpoint
Arm/Group Title Dorsal Column Stimulation Dorsal Root Ganglion Stimulation
Hide 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Oswestry Disability Index for Pain Intensity
Hide 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 Not Reported
3.Other Pre-specified Outcome
Title Change in European Quality of Life 5 Dimension Scale
Hide 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 Not Reported
4.Other Pre-specified Outcome
Title Health Status Measured by Short Form-36 (SF-36)
Hide 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 Not Reported
5.Other Pre-specified Outcome
Title Pain Medication Usage
Hide 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 Not Reported
6.Other Pre-specified Outcome
Title Satisfaction With the Pain Relief
Hide 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 Not Reported
7.Other Pre-specified Outcome
Title Adverse Events Related to the Procedure or Devices
Hide Description Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated.
Time Frame 6 Months
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Patients' Global Impression of Change (PGIC)
Hide 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 Not Reported
Time Frame 10 months
Adverse Event Reporting Description The definitions parallel those listed on clinicaltrials.gov
 
Arm/Group Title Dorsal Column Stimulation Dorsal Root Ganglion Stimulation
Hide 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 (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Hide Serious Adverse Events
Dorsal Column Stimulation Dorsal Root Ganglion Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dorsal Column Stimulation Dorsal Root Ganglion Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Bolash
Organization: Cleveland Clinic
Phone: 216-444-3134
EMail: bolashr@ccf.org
Layout table for additonal information
Responsible Party: Robert Bolash, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03794024    
Other Study ID Numbers: 18-1115
First Submitted: December 31, 2018
First Posted: January 4, 2019
Results First Submitted: June 5, 2020
Results First Posted: June 24, 2020
Last Update Posted: June 24, 2020