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

Primary Purpose

Shoulder Injuries, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Rehabilitation Program (ARP)
Nonspecific Passive Intervention (NPI)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active Rehabilitation Program (ARP)

Nonspecific Passive Intervention (NPI)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in the magnitude of humeral head translations relative to the scapular glenoid
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.
Change in the magnitude of 3D scapular rotations
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.
Changes in average visual analog scale (VAS)
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 Western Ontario Instability Index (WOSI)
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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2021
Last Updated
January 6, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04852640
Brief Title
Mitigating the Impact of Shoulder Movement Dysfunction; a Randomized Controlled Trial
Official Title
Mitigating the Impact of Shoulder Movement Dysfunction; a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries, Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Rehabilitation Program (ARP)
Arm Type
Experimental
Arm 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.
Arm Title
Nonspecific Passive Intervention (NPI)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Active Rehabilitation Program (ARP)
Intervention Description
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
Intervention Name(s)
Nonspecific Passive Intervention (NPI)
Intervention Description
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 Measure Information:
Title
Change in the magnitude of humeral head translations relative to the scapular glenoid
Description
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.
Time Frame
Within four weeks of treatment initiation and within four weeks of treatment termination
Title
Change in the magnitude of 3D scapular rotations
Description
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.
Time Frame
Within four weeks of treatment initiation and within four weeks of treatment termination
Title
Changes in average visual analog scale (VAS)
Description
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.
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
Title
Change in Western Ontario Instability Index (WOSI)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin L Staker, PhD, PT
Organizational Affiliation
University of Minnesota Medical School Department of Rehabilitation Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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