- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04566146
Clinical Prediction Rule for Patients With Shoulder Impingement
A Clinical Prediction Rule to Identify Patients With Shoulder Impingement Syndrome Response to Scapular Training
Study Overview
Status
Conditions
Intervention / Treatment
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?
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 45 patients with subacromial impingement syndrome
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder pain severity using the Arabic version of Shoulder Pain and Disability Index (SPADI)
Time Frame: baseline
|
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.
|
baseline
|
|
Shoulder disability using the Arabic version of Shoulder Pain and Disability Index (SPADI)
Time Frame: baseline
|
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.
|
baseline
|
|
Measuring of scapular upward rotation angle using two bubble inclinometer
Time Frame: baseline
|
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. |
baseline
|
|
Measuring isometric scapular muscle strength using handheld dynamometer (HHD) then calculation of Upper Trapezius/Serratus Anterior strength ratio
Time Frame: baseline
|
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 |
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPR for patients with SIS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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