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

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

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.

Study Overview

• Status: Terminated
• Conditions: Complex Regional Pain Syndromes; Pelvic Pain; Regional Pain Syndrome; Chronic Pain Syndrome; Spinal; Nerve Root, Pain
• Intervention / Treatment: Device: dorsal root ganglion neuromodulation

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • California
    • Murrieta, California, United States, 92563
      • KM Clinical Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients medically indicated to receive DRG stimulator for treatment of chronic lower limb and/or pelvic pain.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
complex regional pain syndrome; 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; stimulation for neuromodulation of the dorsal root ganglion
Chronic pelvic pain; 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; stimulation for neuromodulation of the dorsal root ganglion

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain-related prescription medication use	change in self-reported medication usage and types of medications needed to control pain	12 months post-permanent dorsal root ganglion stimulator implantation

Collaborators and Investigators

• Sponsor: KM Clinical Research Group
• Investigators: Principal Investigator: Kate McLellan, PhD, KM Clinical Research Group

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: dorsal root ganglion
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Chronic Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders; Pelvic Pain
• Other Study ID Numbers: 2017-PN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Other researchers will only see participation data for the subjects they recruit and enroll in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No