Skip to content

Efficacy of First Time Anterior Shoulder Decision Tool

Efficacy of First Time Anterior Shoulder Decision Tool in a Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02656277
Enrollment
210
Registered
2016-01-14
Start date
2016-01-31
Completion date
2016-12-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

Brief summary

This study is a randomized controlled trial using Duke patients to test, compared to the standard of care, a questionnaire and statistical model used to determine how patient preference regarding shoulder pain, physical limitations, physical therapy, recovery period, prognosis, and cost impact choice of surgical versus non-surgical intervention. Phase 1 of this study is the initial testing of the instrument and involves a small group of up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized to receive either the Decision Tool or the standard Information on Shoulder Dislocation

Detailed description

An anterior shoulder dislocation is a common problem for people between the ages of 15 to 35. Recurrent instability is common and dependent on age and gender. Treatment options include surgical intervention and repair or non-surgical options that include intensive rehabilitation. Level I evidence suggests early surgical repair can significantly reduce the risk of recurrent instability. The risk of arthritis is increased with multiple dislocation episodes. Traditionally, the combination of 1) history and physical exam performed by the provider, 2) clinical and diagnostic tools to assess the extent of injury and impact on physical activity, and 3) patient-voiced preference has guided the selection of an optimal solution for an individual patient. When providing a recommendation to individual patients and their unique circumstances, the health care provider may gather patient preferences on factors such as desire to avoid pain, chance of recurrent shoulder dislocation, time needed for rehabilitation and physical therapy, and operative versus non-operative costs. Surgical and non-surgical options have distinct differences in these outcomes. When combined, the interaction between these variables creates important tradeoffs of risks and benefits for each option. No studies have been conducted to determine the objective weight of these different dimensions of patient preferences and how they might guide the provider-patient conversation. Conjoint analysis is a statistical method that seeks to quantify the relative importance of various aspects of the decision-making process, such as cost or probability of repeat injury as described above. Combined with a validated survey tool, conjoint analysis of patient preferences in shoulder repair can assist the physician in recommending a patient-centered option.

Interventions

OTHERInformation on Shoulder Dislocation

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

\- Shoulder dislocation

Exclusion criteria

* Prior surgery for shoulder stabilization * Inability to complete enrollment forms

Design outcomes

Primary

MeasureTime frameDescription
Patient Preference Survey2 monthspatient-voiced preferences guiding solution

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026