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Recruiting NCT04548375

Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol

Observational SCS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCS.
Who it may be relevant to
Registry conditions: SCS. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The objective is to provide information to help the physician community decide the most effective type of device/therapy that would work for their patients, based off of the etiology of pain, the location of the pain for sustained pain relief.

Detailed description

This registry will enroll patients that qualify for an SCS implant, for approved pain areas, as defined by medicare guidelines, and follow these patients for up to 12 months for denovo implants. For patients who have lost their pain relief over time, with a prior implanted device, this registry will follow a change out to another vendor/therapy, and follow those patients for up to 12 months.

Interventions

  • Device SCS
    Conventional SCS implants approved through all payors(government and private) for FDA approved indications

Primary outcome measures

  • Change in pain relief [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • FDA approved indications for SCS implants, for commercial and government(medicare, medi-cal etc) approved payors

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Summit Surgery Center — Reno

Identifiers

NCT: NCT04548375 · PainReg

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗