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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

Tracking Information
First Submitted Date December 31, 2018
First Posted Date January 4, 2019
Results First Submitted Date June 5, 2020
Results First Posted Date June 24, 2020
Last Update Posted Date June 24, 2020
Actual Study Start Date January 8, 2019
Actual Primary Completion Date March 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2019)
Change in Numerical Rating Scale for Pain Intensity [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: January 2, 2019)
50% change in index pain using a Numerical Rating Scale (NRS) for Pain Intensity at 6 months [ Time Frame: 6 Months ]
50% change in index pain 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.
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2019)
Change in Oswestry Disability Index for Pain Intensity [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: January 2, 2019)
30% change in function based on Oswestry Disability Index (ODI) for functional impairment [ Time Frame: 6 Month ]
30% change 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.
Current Other Pre-specified Outcome Measures
 (submitted: June 27, 2019)
  • Change in European Quality of Life 5 Dimension Scale [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 Months ]
    Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated.
  • Patients' Global Impression of Change (PGIC) [ Time Frame: 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.
Original Other Pre-specified Outcome Measures
 (submitted: January 2, 2019)
  • Change in Quality of Life as measured by the European Quality of Life 5 Dimension (EQ-5D) Scale [ Time Frame: 6 Months ]
    Change in Quality of Life as measured by the European Quality of Life 5 Dimension (EQ-5D) Scale. The EQ-5D questionnaire measures the following aspects: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each section will have 3 levels based on severity. Answers result in a 1-digit number. The questionnaire is scored as a total summed based on all patient responses.
  • Change in Health Status measured by Short Form-36 (SF-36) [ Time Frame: 6 Months ]
    Change in Health Status measured by Short Form-36 (SF-36) is form that measures patient's overall health. Scores range from 0 - 100 with lower scores indicating more disability while higher scores indicate less disability.
  • Pre and Post Procedure Pain medication usage [ Time Frame: 6 Months ]
    Pre and Post Procedure Pain medication usage is list of medications used by the patient. All pain medications used need to be added to the list. Any opioids will be calculated as milligrams morphine equivalent. Our outcome measure is change in the medication in terms of dosage and frequency.
  • Satisfaction with the pain relief, therapy in general, and likelihood of undergoing the therapy again for a similar outcome [ Time Frame: 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.
  • Safety defined as adverse events related to the procedure or devices [ Time Frame: 6 Months ]
    Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated.
  • Patients' Global Impression of Change (PGIC) [ Time Frame: 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.
 
Descriptive Information
Brief Title Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome
Official Title Single Center, Randomized Prospective Comparative Effectiveness Study of Dorsal Column Spinal Cord Stimulation to Dorsal Root Ganglion Stimulation in the Treatment of Complex Regional Pain Syndrome
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with Budapest criteria (research diagnostic definition) of Complex Regional Pain Syndrome occurring below the umbilicus who have not had an adequate response to conservative management including analgesic and physical therapies.
Condition Complex Regional Pain Syndrome
Intervention
  • 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.
  • 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
Study Groups/Cohorts
  • Dorsal Column Stimulation
    Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator
    Intervention: Device: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator
  • Dorsal Root Ganglion Stimulation
    Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System
    Intervention: Device: The Axium Neurostimulator System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 5, 2020)
3
Original Estimated Enrollment
 (submitted: January 2, 2019)
62
Actual Study Completion Date March 31, 2020
Actual Primary Completion Date March 3, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03794024
Other Study ID Numbers 18-1115
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Robert Bolash, The Cleveland Clinic
Study Sponsor The Cleveland Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Robert Bolash, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date June 2020