Spinal Cord Stimulation (SCS) Dosing St… | Clinical Trial

Key information

Conditions

Back Pain Leg Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arizona Pain Doctors, Chandler, Arizona, United States

About this study

This feasibility study assessed the following outcomes:

Patient satisfaction
VAS pain scores

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

22 years of age or older
Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month
Has approproate SCS settings
Willing and able to provide signed and dated informed consent
Capable of comprehending and consenting in English
Capable of getting into the supine and sitting positions
Willing and able to comply with all study procedures and visits
On stable (no change in dose, route, or frequency) prescribed pain medications

Exclusion criteria

Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system
Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study
Implanted with quadripolar lead
Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study
Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
Has untreated major psychiatric comorbidity
Has serious drug-related behavioral issues
Has unresolved major issues of secondary gain

Treatment and study plan

Spinal Cord Stimulation

Device

Programming

Primary outcomes

SCS Therapy Satisfaction

Time frame: 8 weeks

To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: "Overall how satisfied or unsatisfied are you with this therapy?". The response choices were as follows: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", "very unsatisfied". Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response "very satisfied", "somewhat satisfied", or "neutral", otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.

Secondary outcomes

Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)

Time frame: 8 weeks

To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Sep 15, 2017
Registry last updated: Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed