Clinical trial NCT04852640: Mitigating the Impact of Shoulder Movement Dysfunction; a Randomized Controlled Trial
Official title: Mitigating the Impact of Shoulder Movement Dysfunction; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Injuries
Shoulder Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed work is to screen the effectiveness of an evidence-based, targeted, treatment intervention versus a non-specific, generalized, treatment intervention to treat symptomatic shoulder instability in collegiate swimmers. The results of the study will allow direct observation of treatment effects designed to mitigate the effects of symptomatic shoulder instability. These results will facilitate the optimization of future treatments and interventions.

Detailed description: Currently, there is an unmet need for an effective method to treat shoulder instability. Namely, there is minimal evidence to mitigate the impact of shoulder instability with non-surgical interventions. The presence of shoulder instability can drastically decrease upper extremity function and lead to subsequent shoulder pathology. While there is observational and retrospective evidence to support the use of specific, guided, therapeutic exercise interventions to treat shoulder instability, there are only two randomized controlled trials (RCT) investigating the effects of these types of interventions. While current evidence demonstrates that rehabilitation interventions are capable of decreasing pain and improving self-reported function in individuals with MDI, these investigations include heterogeneous samples and lack thorough investigation of the biomechanical effects of these interventions. The results of this study will allow direct observation of treatment effects designed to mitigate the effects of symptomatic shoulder instability with gold-standard biomechanical techniques. These results will facilitate the optimization of future treatments and interventions. Further, the results will contribute to the current field of musculoskeletal medicine by enhancing biomechanics-based treatment interventions and promote patient-reported outcomes research. The long-term goal of the proposed research is to expand to investigations of treatment effectiveness to more diverse populations and a broader range of movement-related shoulder dysfunctions.

Eligibility criteria: Inclusion Criteria:

* Be an active member of the University of Minnesota Intercollegiate swim team
* Be able to actively raise arm over 150 degrees as measured with a standard goniometer

Exclusion Criteria:

* Are pregnant or are trying to get pregnant
* Are breastfeeding
* Have a previous history of shoulder surgery within the past 12 months
* Have neck pain at the time of enrollment
* Do not speak English

Primary outcomes:
measure: Change in the magnitude of humeral head translations relative to the scapular glenoid
timeFrame: Within four weeks of treatment initiation and within four weeks of treatment termination
measure: Change in the magnitude of 3D scapular rotations
timeFrame: Within four weeks of treatment initiation and within four weeks of treatment termination
measure: Changes in average visual analog scale (VAS)
timeFrame: Ten minutes to complete; Weekly for nine months, within 1 week of the intervention initiation, within 1 week of the intervention termination, and eight weeks after intervention
measure: Change in Western Ontario Instability Index (WOSI)
timeFrame: Ten minutes to complete; Weekly for nine months, within 1 week of the intervention initiation, within 1 week of the intervention termination, and eight weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Medical School Department of Rehabilitation Medicine
name: Justin L Staker, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: