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

NCT ID: NCT04852640

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-01-04

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.

Conditions

Shoulder Injuries; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Rehabilitation Program (ARP)

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.

Group Type: EXPERIMENTAL

Active Rehabilitation Program (ARP)

Intervention Type: PROCEDURE

The ARP intervention consists of therapeutic exercises designed to increase shoulder strength and endurance using a cluster of common exercises used for the treatment of shoulder pain. Specifically, the ARP program will focus on increasing scapular motor-control through a phasic program of common therapeutic exercises. This concept has been shown in the literature as capable of reducing shoulder pain and improving function in a variety of pathological conditions, however, the effect of this approach to reducing pain and increasing function for symptomatic shoulder instability is unknown. The selection of exercises and application for each exercise included in the ARP is based on recommendations from the literature and will incorporate participant feedback to customize dosages.

Nonspecific Passive Intervention (NPI)

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.

Group Type: EXPERIMENTAL

Nonspecific Passive Intervention (NPI)

Intervention Type: PROCEDURE

The NPI intervention consists of a non-specific treatment approach to shoulder pain that is commonly administered in the clinical setting. Specifically, passive modalities such as ultrasound, massage, and sensory electric stimulation are commonly prescribed in the treatment of shoulder pain to modulate pain. Further, general core strengthening exercises are often implemented. Therefore, the NPI will consist of regularly prescribed passive treatments and general core strengthening exercises, as commonly administered in routine treatment of shoulder pain.

Interventions

Active Rehabilitation Program (ARP)

The ARP intervention consists of therapeutic exercises designed to increase shoulder strength and endurance using a cluster of common exercises used for the treatment of shoulder pain. Specifically, the ARP program will focus on increasing scapular motor-control through a phasic program of common therapeutic exercises. This concept has been shown in the literature as capable of reducing shoulder pain and improving function in a variety of pathological conditions, however, the effect of this approach to reducing pain and increasing function for symptomatic shoulder instability is unknown. The selection of exercises and application for each exercise included in the ARP is based on recommendations from the literature and will incorporate participant feedback to customize dosages.

Intervention Type: PROCEDURE

Nonspecific Passive Intervention (NPI)

The NPI intervention consists of a non-specific treatment approach to shoulder pain that is commonly administered in the clinical setting. Specifically, passive modalities such as ultrasound, massage, and sensory electric stimulation are commonly prescribed in the treatment of shoulder pain to modulate pain. Further, general core strengthening exercises are often implemented. Therefore, the NPI will consist of regularly prescribed passive treatments and general core strengthening exercises, as commonly administered in routine treatment of shoulder pain.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin L Staker, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Medical School Department of Rehabilitation Medicine

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

PMR-2021-29615

Identifier Type: -

Identifier Source: org_study_id