Clinical trial NCT03794024: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Complex Regional Pain Syndrome
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Numerical Rating Scale for Pain Intensity
timeFrame: 6 Months
Secondary outcomes:
measure: Change in Oswestry Disability Index for Pain Intensity
timeFrame: 6 Month
Other outcomes:
measure: Change in European Quality of Life 5 Dimension Scale
timeFrame: 6 Months
measure: Health Status Measured by Short Form-36 (SF-36)
timeFrame: 6 Months
measure: Pain Medication Usage
timeFrame: 6 Months
measure: Satisfaction With the Pain Relief
timeFrame: 6 Months
measure: Adverse Events Related to the Procedure or Devices
timeFrame: 6 Months
measure: Patients' Global Impression of Change (PGIC)
timeFrame: 6 Months
Locations:
city: Cleveland
country: United States
facility: Roberta Johnson
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Robert Bolash, MD
role: PRINCIPAL_INVESTIGATOR
References: