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

NCT03417973 | Terminated DMC FDA Device

• 1 other identifier: 2017-PN-01
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

dorsal root ganglion

Outcome Measures

Primary Outcomes (1)

• Change in pain

  change in visual analogue scale rating

  12 months post-permanent dorsal root ganglion stimulator implantation

Secondary Outcomes (2)

• Change in quality of life

  12 months post-permanent dorsal root ganglion stimulator implantation

• Change in physical health

  12 months post-permanent dorsal root ganglion stimulator implantation

Other Outcomes (1)

• Change in pain-related prescription medication use

  12 months post-permanent dorsal root ganglion stimulator implantation

Study Arms (2)

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

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

Interventions

dorsal root ganglion neuromodulation DEVICE

stimulation for neuromodulation of the dorsal root ganglion

Chronic pelvic pain; complex regional pain syndrome

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Inability or unwillingness to give written informed consent.

Sponsors & Collaborators

• KM Clinical Research Group: lead

Study Sites (1)

KM Clinical Research Group

Murrieta, California, 92563, United States

Location

MeSH Terms

Conditions

Pain; Pelvic Pain; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Kate McLellan, PhD

  KM Clinical Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: January 31, 2018
• Study Start: August 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)