MedTrace Logo

Opioid Reduction Following Spinal Cord Stimulation

NCT02727985 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-01-18

No results posted yet for this study

Summary

The primary purpose of this study is to compare opioid use post-spinal cord stimulation implant at 1, 3, 6, 9 and 12 month intervals in patients who were provided with a weaning schedule by the Neuromodulation team (experimental group) versus those who wean on their own or with their family doctor (control group; standard care) to determine if one strategy is superior to the other.

The secondary objectives will be to further characterize change in opioid use as it relates to pain scores, quality of life and disability from baseline to follow-up assessments. The investigators will examine changes in opioid-related adverse events and medication costs to help understand the impact of opioid weaning on the patient and the system. The investigators will also compare worker's compensation patients with non-worker compensation patients to see if they follow the same result pattern.

Conditions

Interventions

PROCEDURE

Pharmacist weaning schedule

individualized weaning schedule for each patient taking into account the amount of opioid, duration of opioid use, other adjunctive medications, and specific variables related to the patient.

Sponsors & Collaborators

  • Saskatchewan Health Authority - Regina Area

    lead OTHER

Principal Investigators

  • Joseph Buwembo, MD · Saskatchewan Health Authority - Regina Area

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-12-31
Completion
2018-12-27

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02727985 on ClinicalTrials.gov