NCT04566146

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

September 22, 2020

Last Update Submit

September 25, 2020

Conditions

Keywords

clinical prediction ruleshoulder impingement syndromesubacromial impingement syndromescapular training

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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

    baseline

Study Arms (1)

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)

Other: scapular muscle training, serratus anterior strength, scapular stabilization exercises

Interventions

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.

45 patients with subacromial impingement syndrome

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Age 18-45 years old patients diagnosed as subacromial impingement syndrome.
  • \. Patients will be included in this study if they have at least 3 of the following 6 criteria:
  • a. 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.
  • b. 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.
  • c. Pain with active shoulder elevation in the scapular plane.
  • e. Pain with resisted isometric abduction.
  • f. A history of pain in the superior part of lateral arm.
  • \. Demonstration of a painful arc of the arm from 60 to 120 of flexion

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonestrator in the department of physical therapy for musculoskeletal disorders and its surgery, faculty of physical therapy, cairo university

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 28, 2020

Study Start

October 1, 2020

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

September 29, 2020

Record last verified: 2020-09