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Clinical Prediction Rule for Patients With Shoulder Impingement

Primary Purpose

Physical Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
scapular muscle training, serratus anterior strength, scapular stabilization exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Physical Therapy focused on measuring clinical prediction rule, shoulder impingement syndrome, subacromial impingement syndrome, scapular training

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Age 18-45 years old patients diagnosed as subacromial impingement syndrome.
  • 2. Patients will be included in this study if they have at least 3 of the following 6 criteria:
  • 2a. Positive "Neer sign": The examiner passively flexes the humerus with medial rotation to end-range with over pressure. The patient's facial expression and the reproduction of the pain confirm the presence of impingement.
  • 2b. Positive "Hawkins sign": The shoulder is passively placed in approximately 90 degrees of flexion and is passively internally rotated to end-range with overpressure, reproducing the patient's pain.
  • 2c. Pain with active shoulder elevation in the scapular plane.
  • 2e. Pain with resisted isometric abduction.
  • 2f. A history of pain in the superior part of lateral arm.
  • 3. Demonstration of a painful arc of the arm from 60 to 120 of flexion

Exclusion Criteria:

  • 1. Diagnosis of internal shoulder impingement.
  • 2. A history of traumatic onset of shoulder pain.
  • 3. Recent trauma of shoulder.
  • 4. Torn tendons.
  • 5. Ligamentous laxity based on a positive Sulcus and apprehension tests.
  • 6. Numbness or tingling in the upper extremity
  • 7. Cervical discogenic problems.
  • 8. Previous shoulder or cervical spine surgery.
  • 9. Systemic illness.
  • 10. Corticosteroid injection on the shoulder within 1 year of the study.
  • 11. Evidence of central nervous system involvement, or the inability to comply with treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    45 patients with subacromial impingement syndrome

    Arm Description

    Forty-five patients between the age 18 and 45 years old, will be referred by orthopaedist as subacromial impingement syndrome (stage Ⅰ and ⅠⅠ Neer's classification)

    Outcomes

    Primary Outcome Measures

    Shoulder pain severity using the Arabic version of Shoulder Pain and Disability Index (SPADI)
    Pain domain of SPADI (pain symptoms, 5 items): each item will be scored on a visual analogue scale ranging from 0 to 10, where 0 no pain and 10 worst pain imaginable. Total pain score: ….. / 50 x 100 = % Total percentage score ranging from 0 to 100, where 0 best and 100 worst.
    Shoulder disability using the Arabic version of Shoulder Pain and Disability Index (SPADI)
    Disability domain of SPADI (physical function, 8 items): each item will be scored on a visual analogue scale ranging from 0 to 10, where 0 no difficulty and 10 so difficult require help. Total disability score: ….. / 80 x 100 = % Total percentage score ranging from 0 to 100, where 0 best and 100 worst.
    Measuring of scapular upward rotation angle using two bubble inclinometer
    Scapular upward rotation will be measured by using two bubble inclinometers. All patients will be assessed in a relaxed, standing (barefoot) position. One inclinometer is Velcro taped perpendicular to the humeral shaft, just above the humeral epicondyle. The resting position of the humerus will be recorded. The other inclinometer will be placed on the superior border of the spine of the scapula. Next, the patient will instruct to perform shoulder abduction to 100° with full elbow extension, neutral wrist flexion/extension and with the thumb leading to ensure vertical alignment of the inclinometer. When the inclinometer placed on the humerus reached 100°, the therapist records the degree of scapular upward rotation from the inclinometer placed on the spine of the scapula, each patient will perform one test, and then the measurement will recorded.
    Measuring isometric scapular muscle strength using handheld dynamometer (HHD) then calculation of Upper Trapezius/Serratus Anterior strength ratio
    Upper trapezius isometric strength testing: The patient will seat, and the dynamometer will be placed over the superior scapula. The patient then will be asked to elevate the shoulder against resistance. Serratus anterior isometric strength testing: The patient will lay supine with the elbow and shoulder in 90° flexion. The resistance will be applied to the ulna at the olecranon process along the humeral axis. For measurement of the ratio, the isometric strength of both upper trapezius and serratus anterior will be assessed using hand-held dynamometer (HHD) and then the UT/SA ratio will be calculated. Strength = ((HHD reading in Newtons) x (distance)) Bodyweight in kilograms

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2020
    Last Updated
    September 25, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04566146
    Brief Title
    Clinical Prediction Rule for Patients With Shoulder Impingement
    Official Title
    A Clinical Prediction Rule to Identify Patients With Shoulder Impingement Syndrome Response to Scapular Training
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    To investigate if pain severity, scapular upward rotation angle and upper trapezius/serratus anterior isometric strength ratio can predict patient's response to scapular training in patients with subacromial impingement syndrome.
    Detailed Description
    Shoulder impingement syndrome (SIS) is the most commonly diagnosed shoulder disorder. In literature shoulder impingement is reported between 48% and 65% of all painful shoulder conditions. The coordinated coupled motion between the scapula and humerus, the so-called scapulohumeral rhythm (SHR), is needed for efficient arm movement. Reduced scapular mobility reduces the acromio-humeral distance during arm abduction and therefore increases the risk for shoulder impingement syndrome. Clinical prediction rules (CPRs) are tools designed to improve decision making in clinical practice by assisting practitioners in making a particular diagnosis, establishing a prognosis, or matching patients to optimal interventions based on a parsimonious subset of predictor variables from the history and physical examination. HYPOTHESES: Pain severity will not be predictor for treatment success in patients suffering from subacromial impingement syndrome treated with scapular training. Scapular upward rotation angle will not be predictor for treatment success in patients suffering from subacromial impingement syndrome treated with scapular training. Ratio of upper trapezius /serratus anterior isometric strength will not be predictor for treatment success in patients suffering from subacromial impingement syndrome treated with scapular training. RESEARCH QUESTION: Does pain severity, scapular upward rotation angle and upper trapezius/serratus anterior isometric strength ratio predict patient's esponse to scapular training in patients with subacromial impingement syndrome?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Physical Therapy
    Keywords
    clinical prediction rule, shoulder impingement syndrome, subacromial impingement syndrome, scapular training

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    45 patients with subacromial impingement syndrome
    Arm Type
    Other
    Arm Description
    Forty-five patients between the age 18 and 45 years old, will be referred by orthopaedist as subacromial impingement syndrome (stage Ⅰ and ⅠⅠ Neer's classification)
    Intervention Type
    Other
    Intervention Name(s)
    scapular muscle training, serratus anterior strength, scapular stabilization exercises
    Intervention Description
    patients will be scheduled to attend physical therapy three sessions per week for one month. Three sets of 10 repetitions for each exercise were prescribed per session, with a 1-minute rest between sets.
    Primary Outcome Measure Information:
    Title
    Shoulder pain severity using the Arabic version of Shoulder Pain and Disability Index (SPADI)
    Description
    Pain domain of SPADI (pain symptoms, 5 items): each item will be scored on a visual analogue scale ranging from 0 to 10, where 0 no pain and 10 worst pain imaginable. Total pain score: ….. / 50 x 100 = % Total percentage score ranging from 0 to 100, where 0 best and 100 worst.
    Time Frame
    baseline
    Title
    Shoulder disability using the Arabic version of Shoulder Pain and Disability Index (SPADI)
    Description
    Disability domain of SPADI (physical function, 8 items): each item will be scored on a visual analogue scale ranging from 0 to 10, where 0 no difficulty and 10 so difficult require help. Total disability score: ….. / 80 x 100 = % Total percentage score ranging from 0 to 100, where 0 best and 100 worst.
    Time Frame
    baseline
    Title
    Measuring of scapular upward rotation angle using two bubble inclinometer
    Description
    Scapular upward rotation will be measured by using two bubble inclinometers. All patients will be assessed in a relaxed, standing (barefoot) position. One inclinometer is Velcro taped perpendicular to the humeral shaft, just above the humeral epicondyle. The resting position of the humerus will be recorded. The other inclinometer will be placed on the superior border of the spine of the scapula. Next, the patient will instruct to perform shoulder abduction to 100° with full elbow extension, neutral wrist flexion/extension and with the thumb leading to ensure vertical alignment of the inclinometer. When the inclinometer placed on the humerus reached 100°, the therapist records the degree of scapular upward rotation from the inclinometer placed on the spine of the scapula, each patient will perform one test, and then the measurement will recorded.
    Time Frame
    baseline
    Title
    Measuring isometric scapular muscle strength using handheld dynamometer (HHD) then calculation of Upper Trapezius/Serratus Anterior strength ratio
    Description
    Upper trapezius isometric strength testing: The patient will seat, and the dynamometer will be placed over the superior scapula. The patient then will be asked to elevate the shoulder against resistance. Serratus anterior isometric strength testing: The patient will lay supine with the elbow and shoulder in 90° flexion. The resistance will be applied to the ulna at the olecranon process along the humeral axis. For measurement of the ratio, the isometric strength of both upper trapezius and serratus anterior will be assessed using hand-held dynamometer (HHD) and then the UT/SA ratio will be calculated. Strength = ((HHD reading in Newtons) x (distance)) Bodyweight in kilograms
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Age 18-45 years old patients diagnosed as subacromial impingement syndrome. 2. Patients will be included in this study if they have at least 3 of the following 6 criteria: 2a. Positive "Neer sign": The examiner passively flexes the humerus with medial rotation to end-range with over pressure. The patient's facial expression and the reproduction of the pain confirm the presence of impingement. 2b. Positive "Hawkins sign": The shoulder is passively placed in approximately 90 degrees of flexion and is passively internally rotated to end-range with overpressure, reproducing the patient's pain. 2c. Pain with active shoulder elevation in the scapular plane. 2e. Pain with resisted isometric abduction. 2f. A history of pain in the superior part of lateral arm. 3. Demonstration of a painful arc of the arm from 60 to 120 of flexion Exclusion Criteria: 1. Diagnosis of internal shoulder impingement. 2. A history of traumatic onset of shoulder pain. 3. Recent trauma of shoulder. 4. Torn tendons. 5. Ligamentous laxity based on a positive Sulcus and apprehension tests. 6. Numbness or tingling in the upper extremity 7. Cervical discogenic problems. 8. Previous shoulder or cervical spine surgery. 9. Systemic illness. 10. Corticosteroid injection on the shoulder within 1 year of the study. 11. Evidence of central nervous system involvement, or the inability to comply with treatment.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Prediction Rule for Patients With Shoulder Impingement

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