Clinical trial NCT03417973: Quality of Life and Pain Changes Due to DRG Stimulation for Chronic Pain
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spinal; Nerve Root, Pain
Pelvic Pain
Regional Pain Syndrome
Chronic Pain Syndrome
Complex Regional Pain Syndromes
Keywords: dorsal root ganglion
Lead sponsor: KM Clinical Research Group
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients medically indicated to receive DRG stimulator for treatment of chronic lower limb and/or pelvic pain.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in pain
timeFrame: 12 months post-permanent dorsal root ganglion stimulator implantation
Secondary outcomes:
measure: Change in quality of life
timeFrame: 12 months post-permanent dorsal root ganglion stimulator implantation
measure: Change in physical health
timeFrame: 12 months post-permanent dorsal root ganglion stimulator implantation
Other outcomes:
measure: Change in pain-related prescription medication use
timeFrame: 12 months post-permanent dorsal root ganglion stimulator implantation
Locations:
city: Murrieta
country: United States
facility: KM Clinical Research Group
state: California
Study officials:
affiliation: KM Clinical Research Group
name: Kate McLellan, PhD
role: PRINCIPAL_INVESTIGATOR
References: