N/A
Completed N=240
Strategies for Prescribing Analgesics Comparative Effectiveness Trial
Back Pain · Osteoarthritis
Source: ClinicalTrials.gov NCT01583985 ↗
Enrolled (actual)
240
Serious AEs
17.1%
Results posted
Mar 2019
Primary outcomePrimary: Brief Pain Inventory Interference Scale — 3.7; 3.7; 3.4; 3.6 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory Interference Scale |
3.7; 3.7; 3.4; 3.6; 3.6; 3.3 | — |
| SECONDARY Brief Pain Inventory Severity Scale |
4.3; 4.0; 4.1; 4.1; 4.2; 3.6 | — |
| SECONDARY Medication-related Symptom Checklist |
2.3; 1.3; 2.1; 1.3; 1.9; 0.9 | — |
| SECONDARY Falls |
63; 63; 26; 17; 29; 39 | — |
| SECONDARY Hospitalizations |
99; 99; 15; 16; 6; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Veterans with chronic back or lower extremity osteoarthritis pain with moderate-severe intensity and interference with function despite analgesic therapy.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01583985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.