Clinical trial NCT05266391: Injection Technique in Subacromial Impingement Syndrome
Official title: Comparison of Clinical Results of Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections in Subacromial Impingement Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with the diagnosis of Subacromial impingement syndrome who underwent subacromial corticosteroid injections in our interventional physiatry clinic between September 2017 and February 2018 were included in this study.

Brief summary: Since pain is usually accompanied by a substantial effect on daily life that results in the extensive use of healthcare resources. In subacromial impingement syndrome, shoulder pain affects the quality of life negatively by affecting upper extremity functions and interrupting night sleep. It is very important to control the pain in order to reduce the loss to the labor force and prevent the pain from becoming chronic. Various physical treatment methods such as ultrasound, hot pack, transcutaneous electrical nerve stimulation, etc., and injections or medical agents are recommended. This study aimed to compare the effects of ultrasound (US)-guided in comparison to landmark guided subacromial corticosteroids injection on shoulder range of motion (ROM), pain, and functional status in patients with subacromial impingement syndrome (SAIS).

Detailed description: Patients were assigned to two groups: Group-1 included patients who received US-guided subacromial corticosteroid injections; Group-2 included patients who underwent blind subacromial corticosteroid injections. The primary Outcome Measure was a Visual analog scale. Secondary Outcome Measures were Shoulder joint range of motion (ROM), Shoulder Pain and Disability Index (SPADI), The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH).

Eligibility criteria: Inclusion Criteria:

1. Shoulder posterolateral pain that increased with shoulder abduction,
2. Restriction of the shoulder passive and active range of motion (ROM),
3. Patients with positive Neer and Hawkins impingement test,
4. Patients with SAIS whose diagnosis was confirmed by magnetic resonance imaging (MRI), and
5. Patients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate).

Exclusion Criteria:

* Patients who received corticosteroid, local anesthetic, hyaluronic acid, and platelet-rich plasma injections in the shoulder in the last one year,
* patients who had previous history of surgery or fracture in their thorax, neck, upper extremity or shoulder joint,
* patients with a rheumatological, cognitive or psychiatric, central or peripheral neurological disease (stroke, spinal cord injury, brachial plexus injury, etc.),
* patients whose MRI presented a partial or complete rotator cuff tear, calcific tendinitis or labral tear.

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: Change from baseline visual analogue scale score at 1 month
Secondary outcomes:
measure: Shoulder joint range of motion (ROM)
timeFrame: Change from baseline Shoulder joint range of motion at 1 month
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from baseline Shoulder Pain and Disability Index at 1 month
measure: The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH)
timeFrame: Change from baseline The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire at 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
name: Kadriye Ones, Prof
role: STUDY_CHAIR
References: