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

NCT03794024 | Terminated Results FDA Device

• 1 other identifier: 18-1115
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Numerical Rating Scale for Pain Intensity

  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.

  6 Months

Secondary Outcomes (1)

• Change in Oswestry Disability Index for Pain Intensity

  6 Month

Other Outcomes (6)

• Change in European Quality of Life 5 Dimension Scale

  6 Months

• Health Status Measured by Short Form-36 (SF-36)

  6 Months

• Pain Medication Usage

  6 Months

Study Arms (2)

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

Dorsal Root Ganglion Stimulation

Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System

Device: The Axium Neurostimulator System

Interventions

The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator DEVICE

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 Column Stimulation

The Axium Neurostimulator System DEVICE

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

Dorsal Root Ganglion Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Roberta Johnson

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Robert Bolash
• Organization: Cleveland Clinic

bolashr@ccf.org

216-444-3134

Study Officials

• Robert Bolash, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 4, 2019
• Study Start: January 8, 2019
• Primary Completion: March 3, 2020
• Study Completion: March 31, 2020
• Last Updated: February 27, 2023
• Results First Posted: June 24, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)