NCT01583985

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

November 1, 2018

Enrollment Period

3.7 years

First QC Date

April 20, 2012

Results QC Date

March 7, 2018

Last Update Submit

November 6, 2018

Conditions

Back PainOsteoarthritis

Keywords

opioid analgesicschronic painmusculoskeletal pain

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory Interference Scale

    Measure of pain-related functional interference (range 0-10; higher score is worse)

    3 months, 6 months, 9 months, and 12 months

Secondary Outcomes (4)

  • Brief Pain Inventory Severity Scale

    3 months, 6 months, 9 months, and 12 months

  • Medication-related Symptom Checklist

    3 months, 6 months, 9 months, and 12 months

  • Falls

    12 months

  • Hospitalizations

    12 months

Study Arms (2)

Opioid-intensive

ACTIVE COMPARATOR

Opioid-intensive prescribing strategy

Other: Opioid-intensive prescribing strategy

Opioid-avoidant

ACTIVE COMPARATOR

Opioid-avoidant prescribing strategy

Other: Opioid-avoidant prescribing strategy

Interventions

Opioid-intensive prescribing strategyOTHER

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

Opioid-intensive
Opioid-avoidant prescribing strategyOTHER

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

Opioid-avoidant

Eligibility Criteria

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

You may qualify if:

  • Veterans with chronic back or lower extremity osteoarthritis pain with moderate-severe intensity and interference with function despite analgesic therapy.

You may not qualify if:

  • schizophrenia, bipolar disorder, or other psychosis;
  • moderately severe cognitive impairment;
  • anticipated back, knee, or hip surgery within 12 months;
  • anticipated life expectancy of less than 12 months;
  • current chronic daily opioid therapy;
  • absolute contraindications to either prescribing strategy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (7)

  • Krebs EE, Jensen AC, Nugent S, DeRonne B, Rutks I, Leverty D, Gravely A, Noorbaloochi S, Bair MJ, Kroenke K. Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. Contemp Clin Trials. 2017 Nov;62:130-139. doi: 10.1016/j.cct.2017.09.003. Epub 2017 Sep 8.

    PMID: 28893675RESULT

  • Matthias MS, Donaldson MT, Jensen AC, Krebs EE. "I Was a Little Surprised": Qualitative Insights From Patients Enrolled in a 12-Month Trial Comparing Opioids With Nonopioid Medications for Chronic Musculoskeletal Pain. J Pain. 2018 Sep;19(9):1082-1090. doi: 10.1016/j.jpain.2018.04.008. Epub 2018 Apr 30.

    PMID: 29715520RESULT

  • Kroenke K, Stump TE, Kean J, Krebs EE, Damush TM, Bair MJ, Monahan PO. Diagnostic operating characteristics of PROMIS scales in screening for depression. J Psychosom Res. 2021 Aug;147:110532. doi: 10.1016/j.jpsychores.2021.110532. Epub 2021 May 25.

    PMID: 34052655DERIVED

  • Kroenke K, Stump TE, Chen CX, Kean J, Damush TM, Bair MJ, Krebs EE, Monahan PO. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials. Health Qual Life Outcomes. 2021 Feb 4;19(1):41. doi: 10.1186/s12955-021-01674-3.

    PMID: 33541362DERIVED

  • Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. J Affect Disord. 2020 Apr 1;266:100-108. doi: 10.1016/j.jad.2020.01.101. Epub 2020 Jan 23.

    PMID: 32056864DERIVED

  • Koffel E, Kats AM, Kroenke K, Bair MJ, Gravely A, DeRonne B, Donaldson MT, Goldsmith ES, Noorbaloochi S, Krebs EE. Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial. Pain Med. 2020 Jun 1;21(6):1162-1167. doi: 10.1093/pm/pnz221.

    PMID: 31529104DERIVED

  • Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/jama.2018.0899.

    PMID: 29509867DERIVED

MeSH Terms

Conditions

Back PainOsteoarthritisChronic PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMuscular Diseases

Results Point of Contact

Title
Erin Krebs, MD
Organization
Minneapolis VA Health Care System
erin.krebs@va.gov
612-725-2000

Study Officials

  • Erin E. Krebs, MD MPH

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 24, 2012

Study Start

June 1, 2013

Primary Completion

January 31, 2017

Study Completion

May 31, 2017

Last Updated

March 6, 2019

Results First Posted

March 6, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)