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

Not Applicable

Completed

• Conditions: Shoulder Pain; Shoulder Injuries
• Interventions: Procedure: Active Rehabilitation Program (ARP); Procedure: Nonspecific Passive Intervention (NPI)

• Registration Number: NCT04852640
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Study Start: 2021-09-01
• Status Verified: 2023-01
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Rehabilitation Program (ARP)	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.
Nonspecific Passive Intervention (NPI)	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.

Primary Outcome Measures

Name	Time	Method
Change in the magnitude of 3D scapular rotations	Within four weeks of treatment initiation and within four weeks of treatment termination	The magnitude of 3D scapular rotations will be measured as scapular rotations in each anatomical plane relative to the thorax. The three scapular rotations that will be measured are: scapular upward/downward rotation, scapular internal/external rotation, and scapular anterior/posterior tilting. These rotations are measured in degrees. These measurements will be recorded with biplane radiographic motion analysis.
Change in Western Ontario Instability Index (WOSI)	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	The WOSI contains 21 items, each rated on a scale of 0 to 100, and four overarching groups: physical symptoms, sports/recreation/work, lifestyle, and emotion. Composite scores range from 0-2100, where greater scores indicate a reduced quality of life.
Changes in average visual analog scale (VAS)	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	Pain ratings will be measured with a 10cm VAS. The VAS will not have numbers on the scale, as a numeric pain scale would have. Participants will report their pain rating on the VAS scale weekly by sliding the marker along the line on the electronic survey throughout the duration of the study.
Change in the magnitude of humeral head translations relative to the scapular glenoid	Within four weeks of treatment initiation and within four weeks of treatment termination	The magnitude of humeral head translations will be measured as the distance traveled by the humeral head relative to the scapular glenoid. The units of measure for this variable is distance, recorded in millimeters (mm). These measurements will be recorded with biplane radiographic motion analysis.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States