Status:
TERMINATED
Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome
Lead Sponsor:
The Cleveland Clinic
Conditions:
Complex Regional Pain Syndrome
Eligibility:
All Genders
18+ years
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 plac...
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 in...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
January 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03794024
Start Date
January 8 2019
End Date
March 31 2020
Last Update
February 27 2023
Active Locations (1)
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1
Roberta Johnson
Cleveland, Ohio, United States, 44195