A Prospective, Single-Blinded, Dose-Response Study of Spinal Cord Stimulation (SCS) Therapy using Paraesthesia-Free Waveform Patterns in Patients with Chronic Neuropathic Low Back Pai

Not Applicable

Completed

• Conditions: Chronic Neuropathic Low Back Pain; Anaesthesiology - Pain management; Neurological - Other neurological disorders

• Registration Number: ACTRN12618000647235
• Lead Sponsor: Genesis Research Services

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-23
• Study Completion: 2022-04-11
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain rating (VAS) compared to baseline associated with each paraesthesia-free (sub-perception) stimulation level.[At completion of each stimulation threshold treatment period (6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks).]

Secondary Outcome Measures

Name	Time	Method
(1) Change from baseline of quality of life scores measured by the EQ-5D scale<br><br>[at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant<br>];Change from baseline of Brief Pain Inventory scores (BPI)[at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant<br>];Change from baseline of health status scores (SF-36)[at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant<br>]