Risk Factors for Long-term Opioid Use

Opioid Use Among Patients With Pain Syndromes Commonly Seeking Surgical Consultation

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.

Study Overview

• Status: Completed
• Conditions: Pain Syndrome
• Intervention / Treatment: Other: No intervention - retrospective observational cohort study

• Study Type: Observational
• Enrollment (Actual): 1500392

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients enrolled in private health insurance included within the Marketscan database, who generated at least one insurance claim for anorectal, foot/ankle, or TMJ pain.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anorectal; Patients presenting with anorectal pain.	Other: No intervention - retrospective observational cohort study
TMJ; Patients presenting with temporomandibular joint pain.	Other: No intervention - retrospective observational cohort study
Foot/Ankle; Patients presenting with foot and ankle pain.	Other: No intervention - retrospective observational cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term opioid use	opioid prescriptions for 3 months.	>90 days of opioid supply

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 43803

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No