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Trial record 84 of 133 for:    Complex Regional Pain Syndrome

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

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ClinicalTrials.gov Identifier: NCT03417973
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Kate McLellan, KM Clinical Research Group

Brief 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.

Condition or disease Intervention/treatment
Spinal; Nerve Root, Pain Pelvic Pain Regional Pain Syndrome Chronic Pain Syndrome Complex Regional Pain Syndromes 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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in pain [ Time Frame: 12 months post-permanent dorsal root ganglion stimulator implantation ]
    change in visual analogue scale rating


Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: 12 months post-permanent dorsal root ganglion stimulator implantation ]
    change in NIH PROMIS Global health v2 score

  2. Change in physical health [ Time Frame: 12 months post-permanent dorsal root ganglion stimulator implantation ]
    Change in Pain Behavior and Pain Interference measures


Other Outcome Measures:
  1. Change in pain-related prescription medication use [ Time Frame: 12 months post-permanent dorsal root ganglion stimulator implantation ]
    change in self-reported medication usage and types of medications needed to control pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients medically indicated to receive DRG stimulator for treatment of chronic lower limb and/or pelvic pain.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417973


Locations
United States, California
KM Clinical Research Group
Murrieta, California, United States, 92563
Sponsors and Collaborators
KM Clinical Research Group
Investigators
Principal Investigator: Kate McLellan, PhD KM Clinical Research Group

Responsible Party: Kate McLellan, Principle Investigator, KM Clinical Research Group
ClinicalTrials.gov Identifier: NCT03417973     History of Changes
Other Study ID Numbers: 2017-PN-01
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Other researchers will only see participation data for the subjects they recruit and enroll in the study.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kate McLellan, KM Clinical Research Group:
dorsal root ganglion

Additional relevant MeSH terms:
Syndrome
Chronic Pain
Pelvic Pain
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pain
Somatoform Disorders
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases