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Opioid Reduction Following Spinal Cord Stimulation (REDUCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727985
Recruitment Status : Withdrawn (Site did not meet recruitment goals and target numbers)
First Posted : April 5, 2016
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Saskatchewan Health Authority - Regina Area

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Procedure: Pharmacist weaning schedule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Opioid Reduction Following Spinal Cord Stimulation: A Comparison of Two Protocols, Effect on Patient Quality of Life and Cost-Impact to the Healthcare System
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pharmacist weaning schedule
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
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.

No Intervention: Self/Family Physician weaning schedule
Patients will wean off their opioids by themselves or with their family physician without the assistance of a prepared schedule.



Primary Outcome Measures :
  1. Change in number of opioids from baseline to post-intervention at 6-months follow-up [ Time Frame: baseline to 6 months followup ]

Secondary Outcome Measures :
  1. Proportion of patients that reach a 30% reduction in opioid dose (morphine-equivalent) from baseline to post-intervention at 6-months follow-up [ Time Frame: baseline to 6-months followup ]
  2. Change in Number of opioids used at 1, 3, 9 and 12 months follow-up [ Time Frame: baseline and 1, 3, 9 and 12 months followup ]
  3. Change in Mean dose of opioids at 1, 3, 6, 9, 12 months follow up [ Time Frame: baseline and 1, 3, 6, 9 and 12 months followup ]
  4. 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 [ Time Frame: baseline and 1, 3, 9 and 12 months followup ]
  5. Change in visual analogue pain (VAS) score [ Time Frame: baseline and 1, 3, 6, 9 and 12 months followup ]
  6. Change in Euroqol 5D (EQ-5D) score [ Time Frame: baseline and 1, 3, 6, 9 and 12 months followup ]
  7. Change in 36-item short form survey (SF-36) score [ Time Frame: baseline and 1, 3, 6, 9 and 12 months followup ]
  8. Change in Oswestry Disability Index (ODI) score [ Time Frame: baseline and 1, 3, 6, 9 and 12 months followup ]
  9. Change in Pittsburgh Sleep Quality Index (PSQI) score [ Time Frame: baseline and 1, 3, 6, 9 and 12 months followup ]
  10. Change in medication costs ($) [ Time Frame: baseline and 1, 3, 6, 9 and 12 months followup ]
  11. Number of opioid-related adverse events [ Time Frame: baseline and 1, 3, 6, 9 and 12 months followup ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727985


Locations
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Canada, Saskatchewan
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5
Sponsors and Collaborators
Saskatchewan Health Authority - Regina Area
Investigators
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Principal Investigator: Joseph Buwembo, MD Saskatchewan Health Authority - Regina Area
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Responsible Party: Saskatchewan Health Authority - Regina Area
ClinicalTrials.gov Identifier: NCT02727985    
Other Study ID Numbers: REB15-118
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations