TerminatedNot Applicable

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

Stopped: Manufacturer of the device filed for bankruptcy

United States1 participantsStarted 2019-01-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Change in Numerical Rating Scale for Pain Intensity

Timeframe: 6 Months

Trial details

NCT IDNCT03794024

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-03-03

Results submitted2020-06-05