Physical TherapyNCT04566146
Clinical Prediction Rule for Patients With Shoulder Impingement
A study testing scapular muscle training, serratus anterior strength, scapular stabilization exercises in people with Physical Therapy, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Physical Therapy
- What is being tested?
- scapular muscle training, serratus anterior strength, scapular stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
About this study
Official title: A Clinical Prediction Rule to Identify Patients With Shoulder Impingement Syndrome Response to Scapular Training
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.
Read the 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?
- Conditions
- Physical Therapy
- Being tested
- scapular muscle training, serratus anterior strength, scapular stabilization exercises
- Keywords
- clinical prediction rule, shoulder impingement syndrome, subacromial impingement syndrome, scapular training
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scapular muscle training, serratus anterior strength, scapular stabilization exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 45 patients with subacromial impingement syndrome | Other | 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) Receives: Other: scapular muscle training, serratus anterior strength, scapular stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Tarek Khater Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566146
- Sponsor's protocol ID
- CPR for patients with SIS
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Prediction Rule to Identify Patients With Shoulder Impingement Syndrome Response to Scapular Training
- ClinicalTrials.gov ID
- NCT04566146
- Acronym / sponsor ID
- CPR for patients with SIS
- Conditions
- Physical Therapy
- Keywords
- clinical prediction rule, shoulder impingement syndrome, subacromial impingement syndrome, scapular training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 45 patients with subacromial impingement syndrome | Other | Other: scapular muscle training, serratus anterior strength, scapular stabilization exercisesForty-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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scapular muscle training, serratus anterior strength, scapular stabilization exercisespatients 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. | Other | 45 patients with subacromial impingement syndrome |
Primary outcome
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.
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing scapular muscle training, serratus anterior strength, scapular stabilization exercises in people with Physical Therapy, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain severity using the Arabic version of Shoulder Pain and Disability Index (SPADI) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.