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Completed

NCT Number: NCT04852640

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

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.

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Key information

Conditions

Shoulder Injuries Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Rehabilitation Program (ARP)

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)

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.

Primary outcomes

  1. Change in the magnitude of humeral head translations relative to the scapular glenoid

    Time frame: 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.

  2. Change in the magnitude of 3D scapular rotations

    Time frame: 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.

  3. Changes in average visual analog scale (VAS)

    Time frame: 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.

  4. Change in Western Ontario Instability Index (WOSI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2021
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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