NCT03417973

Quality of Life and Pain Changes Due to DRG Stimulation for Chronic Pain

A Prospective Single-arm, Multi-center Clinical Study Examining Quality of Life and Pain Following Dorsal Root Ganglion Stimulation for the Treatment of Chronic Intractable Pelvic and Lower Limb Pain

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: KM Clinical Research Group · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.

Detailed description

Objectives The primary objective is changes in pelvis and/or lower limb pain following dorsal root ganglion (DRG) stimulation. Pain levels will be determined using a 10-point Visual Analog Scale (VAS) with 10= Extreme Pain and 0= No Pain. The null hypothesis is there will be no change in the subjects' self-reported pain levels from baseline to 52 weeks post-stimulator implantation. The alternate hypothesis is a significant change in pain levels. Secondary objectives include changes in physical health, quality of life, and pain-related prescription medication usage. Each subject's overall quality of life will be measured with the National Institute of Health's PROMIS Global Health survey v1.2. Physical activity changes will be assessed using the NIH PROMIS Pain Interference 6a SF v1.0 and Pain Intensity 3a scale v1.0. Finally, patients will be asked the name, dosage, and frequency of use of any pelvic and/or lower limb pain-related prescription medications they are currently using. Design and Outcomes This is a prospective observational single-arm study to access the primary outcome variable of pelvic and/or lower limb pain Intervention and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre and post-operative pain, physical activity levels, quality of life, and medication use. Subjects will be followed for 12 months following their DRG stimulation implant surgery. Sample Size and Population This study will last for 4 years starting July 1, 2017. There will be no maximum subject population size. We aim for a minimum population size of 500 in order to give statistical significance with results. Subjects will be stratified by area of chronic pain.

Conditions

• Spinal; Nerve Root, Pain
• Pelvic Pain
• Regional Pain Syndrome
• Chronic Pain Syndrome
• Complex Regional Pain Syndromes

Interventions

Type	Name	Description
DEVICE	dorsal root ganglion neuromodulation	stimulation for neuromodulation of the dorsal root ganglion

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-02-28
• Completion: 2019-03-31
• First posted: 2018-01-31
• Last updated: 2020-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study