NCT04928131

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,500,392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

8.7 years

First QC Date

June 9, 2021

Last Update Submit

April 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Long-term opioid use

    opioid prescriptions for 3 months.

    >90 days of opioid supply

Secondary Outcomes (1)

  • new long-term opioid use

    >90 days of opioid supply

Study Arms (3)

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

Interventions

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

January 1, 2007

Primary Completion

September 1, 2015

Study Completion

February 1, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04