Rotator Cuff InjuryNCT03105791
The Effect of Patient Education on Opioid Consumption
A study testing Formal education regarding opioid usage in people with Rotator Cuff Injury, run by Rothman Institute Orthopaedics.
Trial summary
Prospective, randomized clinical trial investigating the use of patient education on post-operative narcotic consumption Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- Formal education regarding opioid usage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18
- clinically indicated for an arthroscopic rotator cuff repair
Who cannot join
- Patients with irreparable rotator cuff tears
- allergic or sensitivity to the study medication
- history of gastrointestinal issues
- any evidence of glenohumeral arthritis
- inability to consent
About this study
Prospective, randomized clinical trial investigating the use of patient education on post-operative narcotic consumption
- Conditions
- Rotator Cuff Injury
- Being tested
- Formal education regarding opioid usage
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal education regarding opioid usageOther
Participannts watched a 2 minute video and were given educational materials
| Study group | Role | What they receive |
|---|---|---|
| Normal pre-operative education | No intervention | • Control group received normal pre-operative education regarding surgery |
| Opioid usage education | Active comparator | • The study group received formal education detailing recommended post-operative opioid usage, side effects, dependence, and addiction Receives: Other: Formal education regarding opioid usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Usage
count of total narcotic pills not taken by patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105791
- Sponsor's protocol ID
- 2017Abb
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Education on Opioid Consumption
- ClinicalTrials.gov ID
- NCT03105791
- Acronym / sponsor ID
- 2017Abb
- Conditions
- Rotator Cuff Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Apr 2017 (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.
Prospective, randomized clinical trial investigating the use of patient education on post-operative narcotic consumption
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal pre-operative education | No intervention | –• Control group received normal pre-operative education regarding surgery |
| Opioid usage education | Active comparator | Other: Formal education regarding opioid usage• The study group received formal education detailing recommended post-operative opioid usage, side effects, dependence, and addiction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 18
- clinically indicated for an arthroscopic rotator cuff repair
Key exclusion criteria (5 listed)
- Patients with irreparable rotator cuff tears
- allergic or sensitivity to the study medication
- history of gastrointestinal issues
- any evidence of glenohumeral arthritis
- inability to consent
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 |
|---|---|---|
| Formal education regarding opioid usageParticipannts watched a 2 minute video and were given educational materials | Other | Opioid usage education |
Primary outcome
Opioid Usage
Time frame: 3 months
count of total narcotic pills not taken by patients
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 10 Apr 2017.
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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?
A study testing Formal education regarding opioid usage in people with Rotator Cuff Injury, run by Rothman Institute Orthopaedics.
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 2 inclusion and 5 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 10 Apr 2017. 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?
Opioid Usage (time frame: 3 months). 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 10 Apr 2017.