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Therapeutic Progressive Exercise on Shoulder Impingement Syndrome

Primary Purpose

Shoulder Impingement, Tendinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuromuscular resistance exercise program
Control exercise program with elastic band
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement focused on measuring shoulder impingement syndrome, tendinopathy, exercise

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects older than 18 years.
  • Subjects previously diagnosed with shoulder impingement syndrome.
  • Presence of 3 of the following sings: impingement sign according to Neer and to Hawking-Kennedy, positive result on Jobes test, painful arc, and positive result on Patte's manoeuvre.

Exclusion Criteria:

  • Findings of spinal radiculopathy.
  • General neck and shoulder pain.
  • Symptoms of frozen shoulder.
  • Pregnancy.
  • Fybromyalgia.
  • Suspected polyarthritis.
  • Chronic pain syndrome.
  • Altered blood coagulation.
  • Consumption of anticoagulants, opioids or antiepileptics.
  • Drug intakes.
  • Alcohol intakes higher than 27.4 grams for men or 13.7 grams for women.
  • Allergies.
  • Cancer.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Neuromuscular resistance exercise group

    Control exercise group

    Arm Description

    Subjects will develop an innovator program consisting in the performance of exercises of increasing difficulty, with movements based on functional tests to analyze the subjects' neuromuscular capacities. Participants will attend to 80 individual, face-to-face physiotherapy sessions, including both supervised and semi-supervised monitoring. From the total, a minimum of 15 sessions will be supervised, including 6 sessions to teach and monitor the exercises, and 9 sessions to perform the tests in order to quantify the load; 37 sessions will be semi-supervised, where subjects will perform the exercises independently, but with the presence of an instructor; additionally, the remaining 28 sessions will consist in non-supervised aerobic work at a 70-80% from maximum heart rate, obtained according to the methodology of Tanaka et al.

    This program will be based on a home exercise protocol considering painful sensation and self-perceived stability as progression criteria: regarding pain management, exercises will be planned in a way that increased pain after their performance reverts to before-exercise levels prior to the next session; regarding self-perceived stability, participants will be asked to maintain a constant sensation of joint stability and control during the execution of the exercises. Participants will perform shoulder rotations (external and internal) and abduction up to 30º by using elastic bands. The resistance of the band will be adjusted by the physiotherapist so that participants perceive the exercises as demanding enough but not too unpleasant, being able to complete the 10 repetitions before taking the rest. Likewise, exercises will progress until a maximum of 90º of shoulder abduction.

    Outcomes

    Primary Outcome Measures

    Change from baseline in Function measured with Disability of the Arm, Shoulder and Hand (DASH)
    Functional scores from Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Score ranges from 0 (no disability) to 100 (most severe disability)
    Change from baseline in Function measured with Constant-Murley Score (CMS)
    Functional scores from Constant-Murley Score (CMS) Constant-Murley score (CMS) is a 100-points scale: the higher the score, the higher the quality of the function.
    Change from baseline in Function measured with Upper Limb Functional Index (ULFI)
    Functional scores from Upper Limb Functional Index (ULFI) Score ranges from 0 (no disability) to 25 (most severe disability)
    Change from baseline Painful Sensation
    Pain scores from Visual Analogue Scale (VAS) Score ranges from 0 (no pain) to 10 (most severe pain)
    Change from baseline Range of motion (ROM)
    Active shoulder joint ROM (flexion, extension, abduction, internal/external rotations) by goniometry
    Change from baseline Subacromial Space
    Measurement of subacromial space by ultrasonography

    Secondary Outcome Measures

    Change from baseline Quality of Life
    Quality of life scores from EuroQol-5D questionnaire EQ-5D embodies two components: Health state description: subjects select one of three different levels of problem severity within each of five health domains. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively), whilst the domains are mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression. Evaluation: using a visual analogue scale (VAS), ranging from 0 ("worst imaginable health state") and at 100 ("best imaginable health state")
    Change from baseline Health Status
    Health status scores from Short-Form 12 (SF-12) questionnaire SF-12 gathers information from eight domains: the higher the scores, the better the health)

    Full Information

    First Posted
    December 21, 2020
    Last Updated
    October 5, 2021
    Sponsor
    University of Malaga
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04690049
    Brief Title
    Therapeutic Progressive Exercise on Shoulder Impingement Syndrome
    Official Title
    An Innovative Therapeutic Exercise Approach Based on Load Progression Criteria for the Management of Shoulder Impingement Syndrome: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaga

    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
    Upper limb tendinopathies, especially the so called "shoulder impingement syndrome", is a common injury among the population. Its management usually involves active treatments, being the therapeutic progressive exercise the most important and effective modality. However, whether a certain criterion is more appropriate than another when progressing the exercise program remains unclear. We propose a new program based on progressive exercises serving as a standard approach for the management of shoulder impingement syndrome.
    Detailed Description
    Shoulder pain is a common condition affecting our society. It is estimated that between 7 and 67% of the adult population will suffer from shoulder pain at least once in their lifetime. Some research suggest that shoulder impingement syndrome (SIS) is responsible for 44 to 60% from the medical consultations regarding shoulder pain with an approximate prevalence of 70-200 per 1000 adults, which implies a remarkable use of health care resources. Among all the musculoskeletal injuries affecting the shoulder complex, SIS remains as the most common condition, characterized for leading to loss function and disability. Its pathogenesis is associated with the affection of diverse structures and tissues like the subacromial bursa, rotator cuff tendons, acromion, coracoacromial ligament and the long head of biceps brachii. The etiology of this condition comprises multiple causes, including capsular tightness, alteration of shoulder kinematics with scapula dysfunction and muscle imbalance, and also the overuse factor. Treatment modalities to deal with SIS embrace both surgical procedures, i.e., arthroscopic subacromial decompression) and conservative approaches (i.e., physical therapy), becoming the therapeutic exercise increasingly popular due to arising evidence from the last 30 years. Furthermore, with regard to potential effects, therapeutic exercise presents itself as a safer and less aggressive alternative, causing fewer adverse effects than pharmacological or surgical options, which are relegated preferably as secondary choices. There is a wide evidence supporting the exercise therapy as an effective strategy for the management of SIS. However, some controversy exists regarding the optimal approach in terms of intensity, frequency and number of repetitions. Thus, a program acting as a gold standard for the development and progression of the proposed exercises is still lacking, especially when attempting to estimate the pure effect of progressive exercise in isolation between experimental and control group. Prior research evaluating the effect of progressive exercise for the management of SIS usually included programs with a duration of 3 months. However, other studies established follow-up periods of either one month and a half or, conversely, more than 6 months. That, together with the wide variety of post-treatment follow-ups, makes it difficult to find the optimal period where the results derived inherently from the intervention and not from the natural course of the condition may be observed. Regarding the progression criteria, there seems to be a tendency to consider the modulation of the painful sensation as the main benchmark from which the exercise may progress in difficulty, but some other progression sub-criteria can also be found, such as fatigue or subjective perception. Furthermore, the presence of other conditioning elements, like proximity to pain threshold or a certain reference value in the Visual Analogue Scale (VAS), reduces the homogeneity among the exercise programs and hinders the standardization of the ideal exercise progression when performing the exercises for the management of SIS. The main objective of this clinical trial is to prove the efficacy of a progressive exercise program based on strength and resistance training in comparison to an exercise protocol from the literature to increase neuromuscular and cardiorespiratory capacities and improve the symptoms in subjects with SIS. In addition, we propose to determine the existence or not of statistically significant differences between treatment modalities by evaluating whether these changes occur before, during or after the application of the proposed exercise protocol.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Impingement, Tendinopathy
    Keywords
    shoulder impingement syndrome, tendinopathy, exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neuromuscular resistance exercise group
    Arm Type
    Experimental
    Arm Description
    Subjects will develop an innovator program consisting in the performance of exercises of increasing difficulty, with movements based on functional tests to analyze the subjects' neuromuscular capacities. Participants will attend to 80 individual, face-to-face physiotherapy sessions, including both supervised and semi-supervised monitoring. From the total, a minimum of 15 sessions will be supervised, including 6 sessions to teach and monitor the exercises, and 9 sessions to perform the tests in order to quantify the load; 37 sessions will be semi-supervised, where subjects will perform the exercises independently, but with the presence of an instructor; additionally, the remaining 28 sessions will consist in non-supervised aerobic work at a 70-80% from maximum heart rate, obtained according to the methodology of Tanaka et al.
    Arm Title
    Control exercise group
    Arm Type
    Active Comparator
    Arm Description
    This program will be based on a home exercise protocol considering painful sensation and self-perceived stability as progression criteria: regarding pain management, exercises will be planned in a way that increased pain after their performance reverts to before-exercise levels prior to the next session; regarding self-perceived stability, participants will be asked to maintain a constant sensation of joint stability and control during the execution of the exercises. Participants will perform shoulder rotations (external and internal) and abduction up to 30º by using elastic bands. The resistance of the band will be adjusted by the physiotherapist so that participants perceive the exercises as demanding enough but not too unpleasant, being able to complete the 10 repetitions before taking the rest. Likewise, exercises will progress until a maximum of 90º of shoulder abduction.
    Intervention Type
    Other
    Intervention Name(s)
    Neuromuscular resistance exercise program
    Intervention Description
    This neuromuscular resistance exercise program will be organized in 5 stages, distributing the different phases in 2, 4, 4, 2 and 2 weeks respectively, with a frequency of 3 sessions/week. In addition, 2 weekly sessions of aerobic work with cycloergometer will be developed. The duration of each session will last 30 minutes. The parameters of load and execution speed will be modified as the exercise program progresses along the phases, with the goal of have an impact on the different aspects of the neuromuscular system.
    Intervention Type
    Other
    Intervention Name(s)
    Control exercise program with elastic band
    Intervention Description
    This program is based on previous literature so that it remains comparable to the experimental program. The parameters will consist in 3 sets of 10 repetitions, 2 times/day, 3 times/week, for a total of 6 weeks.
    Primary Outcome Measure Information:
    Title
    Change from baseline in Function measured with Disability of the Arm, Shoulder and Hand (DASH)
    Description
    Functional scores from Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Score ranges from 0 (no disability) to 100 (most severe disability)
    Time Frame
    14 weeks
    Title
    Change from baseline in Function measured with Constant-Murley Score (CMS)
    Description
    Functional scores from Constant-Murley Score (CMS) Constant-Murley score (CMS) is a 100-points scale: the higher the score, the higher the quality of the function.
    Time Frame
    14 weeks
    Title
    Change from baseline in Function measured with Upper Limb Functional Index (ULFI)
    Description
    Functional scores from Upper Limb Functional Index (ULFI) Score ranges from 0 (no disability) to 25 (most severe disability)
    Time Frame
    14 weeks
    Title
    Change from baseline Painful Sensation
    Description
    Pain scores from Visual Analogue Scale (VAS) Score ranges from 0 (no pain) to 10 (most severe pain)
    Time Frame
    14 weeks
    Title
    Change from baseline Range of motion (ROM)
    Description
    Active shoulder joint ROM (flexion, extension, abduction, internal/external rotations) by goniometry
    Time Frame
    14 weeks
    Title
    Change from baseline Subacromial Space
    Description
    Measurement of subacromial space by ultrasonography
    Time Frame
    14 weeks
    Secondary Outcome Measure Information:
    Title
    Change from baseline Quality of Life
    Description
    Quality of life scores from EuroQol-5D questionnaire EQ-5D embodies two components: Health state description: subjects select one of three different levels of problem severity within each of five health domains. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively), whilst the domains are mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression. Evaluation: using a visual analogue scale (VAS), ranging from 0 ("worst imaginable health state") and at 100 ("best imaginable health state")
    Time Frame
    14 weeks
    Title
    Change from baseline Health Status
    Description
    Health status scores from Short-Form 12 (SF-12) questionnaire SF-12 gathers information from eight domains: the higher the scores, the better the health)
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects older than 18 years. Subjects previously diagnosed with shoulder impingement syndrome. Presence of 3 of the following sings: impingement sign according to Neer and to Hawking-Kennedy, positive result on Jobes test, painful arc, and positive result on Patte's manoeuvre. Exclusion Criteria: Findings of spinal radiculopathy. General neck and shoulder pain. Symptoms of frozen shoulder. Pregnancy. Fybromyalgia. Suspected polyarthritis. Chronic pain syndrome. Altered blood coagulation. Consumption of anticoagulants, opioids or antiepileptics. Drug intakes. Alcohol intakes higher than 27.4 grams for men or 13.7 grams for women. Allergies. Cancer.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antonio Cuesta-Vargas, PhD
    Phone
    +34951952852
    Email
    acuesta@uma.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonio Cuesta-Vargas, PhD
    Organizational Affiliation
    University of Malaga
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    If further decided, IPD will be shared under request.
    Citations:
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    15163107
    Citation
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