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Strategies for Prescribing Analgesics Comparative Effectiveness Trial

NCT01583985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2019-03-06

Study results available
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Summary

Chronic musculoskeletal pain conditions are among the most prevalent conditions in VA primary care. Over the past two decades, improved clinical attention to pain has been associated with exponentially greater use of long-term opioid therapy for chronic non-cancer pain, both within and outside the VA system. Despite this change in practice, the proper place of opioids in chronic pain management continues to be controversial because research has not demonstrated the long-term safety and effectiveness of opioids for chronic musculoskeletal pain. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) Trial will fill a critical gap in the evidence by comparing effectiveness and harms of two clinically relevant analgesic prescribing strategies-one that emphasizes early use of strong opioids and one that delays and minimizes opioid use-for Veterans with chronic back, hip, or knee pain. SPACE is designed to be highly relevant to clinical decision-making in VA primary care and to produce knowledge that will improve the lives of Veterans living with chronic pain.

Conditions

Interventions

OTHER

Opioid-intensive prescribing strategy

The opioid-intensive arm emphasizes early use of strong opioid analgesics. Medications will be individually adjusted according to patient preferences and responses.

OTHER

Opioid-avoidant prescribing strategy

The opioid-avoidant prescribing strategy emphasizes non-opioid medications from several drug classes. Medications will be individually adjusted according to patient preferences and responses.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Erin E. Krebs, MD MPH · Minneapolis VA Health Care System, Minneapolis, MN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-01
Primary Completion
2017-01-31
Completion
2017-05-31

Countries

  • United States

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 NCT01583985 on ClinicalTrials.gov