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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: dorsal root ganglion neuromodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prescribed orthopedic surgery or procedure by their healthcare provider. Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief. Willing and able to adhere to the protocol of the study including the survey timeline. Between the ages of 18-85 years. Exclusion Criteria: Inability or unwillingness to give written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| complex regional pain syndrome<br>Chronic regional pain of lower limb(s) patients medically indicated to have dorsal root ganglion (DRG) stimulation for control of pain. DRG stimulator will be implanted for trial of 3-4 days and then permanently, if patient find acceptable levels of pain control with trial. | Device: dorsal root ganglion neuromodulation<br>* stimulation for neuromodulation of the dorsal root ganglion<br>|
| Chronic pelvic pain<br>Chronic pelvic or urological pain patients medically indicated to have dorsal root ganglion (DRG) stimulation for control of pain. DRG stimulator will be implanted for trial of 3-4 days and then permanently, if patient find acceptable levels of pain control with trial. | Device: dorsal root ganglion neuromodulation<br>* stimulation for neuromodulation of the dorsal root ganglion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | change in visual analogue scale rating | 12 months post-permanent dorsal root ganglion stimulator implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | change in NIH PROMIS Global health v2 score | 12 months post-permanent dorsal root ganglion stimulator implantation | 
| Change in physical health | Change in Pain Behavior and Pain Interference measures | 12 months post-permanent dorsal root ganglion stimulator implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dorsal root ganglion