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

Pelvic Pain Clinical Trial

— ACTIVE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03417973
• Other study ID #: 2017-PN-01
• Status: Terminated
• Start date: August 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: March 2020
• Source: KM Clinical Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: March 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Complex Regional Pain Syndromes
• Pelvic Pain
• Reflex Sympathetic Dystrophy
• Regional Pain Syndrome
• Somatoform Disorders
• Spinal; Nerve Root, Pain
• Syndrome

Intervention

Device:
• dorsal root ganglion neuromodulation
stimulation for neuromodulation of the dorsal root ganglion

Locations

Country	Name	City	State
United States	KM Clinical Research Group	Murrieta	California

Sponsors (1)

Lead Sponsor	Collaborator
KM Clinical Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Change in pain	change in visual analogue scale rating	12 months post-permanent dorsal root ganglion stimulator implantation
Secondary	Change in quality of life	change in NIH PROMIS Global health v2 score	12 months post-permanent dorsal root ganglion stimulator implantation
Secondary	Change in physical health	Change in Pain Behavior and Pain Interference measures	12 months post-permanent dorsal root ganglion stimulator implantation