NCT02727985

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

March 18, 2016

Last Update Submit

January 14, 2020

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Change in number of opioids from baseline to post-intervention at 6-months follow-up

    baseline to 6 months followup

Secondary Outcomes (11)

  • Proportion of patients that reach a 30% reduction in opioid dose (morphine-equivalent) from baseline to post-intervention at 6-months follow-up

    baseline to 6-months followup

  • Change in Number of opioids used at 1, 3, 9 and 12 months follow-up

    baseline and 1, 3, 9 and 12 months followup

  • Change in Mean dose of opioids at 1, 3, 6, 9, 12 months follow up

    baseline and 1, 3, 6, 9 and 12 months followup

  • Proportion of patients that reach a 30% reduction in opioid dose (morphine-equivalent) from baseline to post-intervention at 1, 3, 9 and 12 months follow-up

    baseline and 1, 3, 9 and 12 months followup

  • Change in visual analogue pain (VAS) score

    baseline and 1, 3, 6, 9 and 12 months followup

  • +6 more secondary outcomes

Study Arms (2)

Pharmacist weaning schedule

EXPERIMENTAL

The Neuromodulation clinic pharmacist will develop a weaning schedule for these patients. Schedules will be individualized taking into account the amount of opioid, duration of opioid use, other adjunctive medications, and specific variables related to the patient.

Procedure: Pharmacist weaning schedule

Self/Family Physician weaning schedule

NO INTERVENTION

Patients will wean off their opioids by themselves or with their family physician without the assistance of a prepared schedule.

Interventions

Pharmacist weaning schedulePROCEDURE

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.

Pharmacist weaning schedule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be taking at least 1 opioid for a minimum of 6 months
  • Subject is a candidate for spinal cord stimulation procedure

You may not qualify if:

  • Palliative
  • Documented substance abuse
  • Subject less than 18 years of age
  • Subject is unwilling or unable to attend required visits and/or comply with study requirements
  • Subjects are unable to undergo study assessments or complete questionnaires independently i.e.: illiterate
  • Subject has enrolled or plans to enroll in any study that might confound the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Buwembo, MD

    Saskatchewan Health Authority - Regina Area

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 5, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 27, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

CA(1)