Pain SyndromeNCT04928131
Risk Factors for Long-term Opioid Use
An observational study of Pain Syndrome, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain Syndrome
- How many people
- 1,500,392 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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.
- Conditions
- Pain Syndrome
- Being tested
- No intervention - retrospective observational cohort study
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - retrospective observational cohort studyOther
| Study group | Role | What they receive |
|---|---|---|
| Anorectal | Patients presenting with anorectal pain. Receives: Other: No intervention - retrospective observational cohort study | |
| TMJ | Patients presenting with temporomandibular joint pain. Receives: Other: No intervention - retrospective observational cohort study | |
| Foot/Ankle | Patients presenting with foot and ankle pain. Receives: Other: No intervention - retrospective observational cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term opioid use
opioid prescriptions for 3 months.
Measured: >90 days of opioid supply
Secondary outcomes (1)
new long-term opioid use
Opioid prescriptions for over 3 months in patients who have not had prior opioid prescriptions.
Measured: >90 days of opioid supply
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study startJan 2007
- Primary completionSep 2015
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Kin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928131
- Sponsor's protocol ID
- 43803
- Status last verified
- Apr 2022
- First submitted
- 9 Jun 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Use Among Patients With Pain Syndromes Commonly Seeking Surgical Consultation
- ClinicalTrials.gov ID
- NCT04928131
- Acronym / sponsor ID
- 43803
- Conditions
- Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500,392 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorectal | – | Other: No intervention - retrospective observational cohort studyPatients presenting with anorectal pain. |
| TMJ | – | Other: No intervention - retrospective observational cohort studyPatients presenting with temporomandibular joint pain. |
| Foot/Ankle | – | Other: No intervention - retrospective observational cohort studyPatients presenting with foot and ankle pain. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - retrospective observational cohort study | Other | Anorectal, Foot/Ankle, TMJ |
Primary outcome
Long-term opioid use
Time frame: >90 days of opioid supply
opioid prescriptions for 3 months.
1 secondary outcome
new long-term opioid use
Time frame: >90 days of opioid supply
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Syndrome, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term opioid use (time frame: >90 days of opioid supply). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022; AzTrials last refreshed its copy on 2 Nov 2026.