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

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ClinicalTrials.gov Identifier: NCT04852640
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Shoulder Injuries Shoulder Pain Procedure: Active Rehabilitation Program (ARP) Procedure: Nonspecific Passive Intervention (NPI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mitigating the Impact of Shoulder Movement Dysfunction; a Randomized Controlled Trial
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Experimental: 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.
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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852640


Contacts
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Contact: Justin L Staker, PhD, PT (612)-626-2746 stak@umn.edu
Contact: Oliver A Silverson, MS, ATC (207)-450-9507 silve567@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Justin L Staker, PhD, PT    612-626-2746    stak@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Justin L Staker, PhD, PT University of Minnesota Medical School Department of Rehabilitation Medicine
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04852640    
Other Study ID Numbers: PMR-2021-29615
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Shoulder Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Wounds and Injuries