Pain Syndrome Clinical Trial
Official title:
Opioid Use Among Patients With Pain Syndromes Commonly Seeking Surgical Consultation
| NCT number | NCT04928131 |
| Other study ID # | 43803 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2007 |
| Est. completion date | February 2021 |
| Verified date | April 2022 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Surgeons often see patients with pain to exclude organic pathology and consider surgical treatment. We examined factors associated with long-term opioid therapy among patients with foot/ankle, anorectal, and temporomandibular joint pain to aid clinical decision making. Using the IBM MarketScan® Research Database, we conducted a retrospective cohort analysis of patients aged 18-64 with a clinical encounter for foot/ankle, anorectal, or temporomandibular joint pain (January 2007-September 2015). Multivariable logistic regression was used to estimate adjusted odds ratios for factors associated with long-term opioid therapy, including age, sex, geographic region, pain condition, psychiatric diagnoses, and surgical procedures in the previous year.
| Status | Completed |
| Enrollment | 1500392 |
| Est. completion date | February 2021 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 64 Years |
| Eligibility | Inclusion Criteria: - 18-64 years old - at least one encounter for anorectal, foot/ankle, or TMJ pain - Marketscan continuous enrollment for 1 year prior and 1 year after the index pain encounter |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Long-term opioid use | opioid prescriptions for 3 months. | >90 days of opioid supply | |
| Secondary | new long-term opioid use | Opioid prescriptions for over 3 months in patients who have not had prior opioid prescriptions. | >90 days of opioid supply |
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