Mitigating the Impact of Shoulder Movement Dysfunction; a Randomized Controlled Trial

University of Minnesota (UMN)

Status: Completed

Conditions: Shoulder Pain; Shoulder Injuries

Treatments: Procedure: Nonspecific Passive Intervention (NPI); Procedure: Active Rehabilitation Program (ARP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04852640

PMR-2021-29615

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Active Rehabilitation Program (ARP)

Experimental group

Description:

Participants will be treated for symptomatic shoulder instability with the evidence-based, targeted treatment intervention. For eight weeks, there will be two treatment sessions per week lasting 30-45 minutes. Exercises in the ARP include: Low-load and high-duration rotator cuff strengthening exercises, progressive scapular muscle endurance training, plyometric strengthening exercises, and surface electromyographic (EMG) biofeedback. Each prescribed exercise in the ARP will be increased to match the participant's function at the discretion of the study clinician. Although the components of the ARP will be pre-determined, the parameters and volumes of the components will be determined and documented over the treatment phase.

Treatment:

Procedure: Active Rehabilitation Program (ARP)

Nonspecific Passive Intervention (NPI)

Experimental group

Description:

Participants will be treated for symptomatic shoulder instability with the non-specific, generalized treatment intervention. For eight weeks, there will be two treatment sessions per week lasting 30-45 minutes. The NPI consists of a general approach to treating shoulder pain with passive modalities for pain modulation. These interventions are commonly practiced but have little evidence to support their use in the treatment of symptomatic shoulder instability. Although the components of the NPI will be pre-determined, the parameters and volumes of the components will be determined and documented by a study clinician over the treatment phase.

Treatment:

Procedure: Nonspecific Passive Intervention (NPI)