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Clinical Trials/ACTRN12618000647235
ACTRN12618000647235
Completed
未知

A Prospective, Single-Blinded, Dose-Response Study of SCS Therapy using Paraesthesia-Free Waveform Patterns in Patients with Chronic Neuropathic Low Back Pain

Genesis Research Services0 sites27 target enrollmentApril 23, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Chronic Neuropathic Low Back Pain
Sponsor
Genesis Research Services
Enrollment
27
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study was testing if a new form of spinal cord stimulation (SCS) programming can reduce chronic neuropathic low back pain. Twenty-seven patients were implanted with a stimulator and participated in the study. On average, patients had lived with low back pain for 14 years, and the average pain score before study treatment was 72 out of 100. All patients trialed up to 3 different SCS study programs in the first 14 weeks and then selected their best program for the rest of the study. Three patients dropped out of the study due to adverse events. There were no serious adverse events related to the study treatment or procedures. After 6-months of SCS treatment, pain score was reduced by 51.7 points on average, and 77% of patients had 50% or more pain relief. After 12-months, pain score was reduced by 43.9 points on average, and 65% of patients had 50% or more pain relief. Patients also had significant improvements to quality-of-life and health survey scores. At the end of the study, 83% of patients were satisfied with their treatment.

Registry
who.int
Start Date
April 23, 2018
End Date
April 11, 2022
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Genesis Research Services

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older
  • \- Physician diagnosed neuropathic low back pain
  • \- Candidate for trial of SCS therapy

Exclusion Criteria

  • \-Meets any contraindication for SCS therapy
  • \-Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator

Outcomes

Primary Outcomes

Not specified

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