Injection Technique in Subacromial Impingement Syndrome

Completed

• Conditions: Subacromial Impingement Syndrome
• Interventions: Other: subacromial corticosteroid injections

• Registration Number: NCT05266391
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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).

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-09-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Last Update Submitted: 2022-02-28
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	subacromial corticosteroid injections	patients who received US-guided subacromial corticosteroid injections
group 2	subacromial corticosteroid injections	patients who underwent blind subacromial corticosteroid injections

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	Change from baseline visual analogue scale score at 1 month	It is a scale scored from 0 to 10 to evaluate the severity of pain. Patients are asked to rate the pain they feel as '0' for no pain and '10' for the most severe pain they have encountered in their life

Secondary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	Change from baseline Shoulder Pain and Disability Index at 1 month	It is a scale in which pain and the limitation of shoulder function are evaluated between 0 and 10 points. Five items for the pain is scored 0 for "no pain," and 10 points for "most severe pain." Eight items for disability is scored 0 for "no difficulty," and 10 points for "difficulty requiring assistance." SPADI is a useful scale in both clinical practice and clinical trials, as it can also detect changes in the status of patients
Shoulder joint range of motion (ROM)	Change from baseline Shoulder joint range of motion at 1 month	Shoulder ROMs were evaluated using a goniometer according to the standard method. Those with shoulder flexion lower than 160° and external rotation lower than 90° were recorded as restricted ROM
The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH)	Change from baseline The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire at 1 month	It is used to evaluate the difficulty in performing various physical activities due to disabilities of the shoulder, arm or hand (6 items), the severity of pain and tingling (2 items), and the effect of the disability on social activities, work, and sleep (3 items). It is the shortened version of the DASH (Disabilities of the Arm, Shoulder and Hand Questionnaire) in 11 items. Each item is scored between 1 and 5. "No difficulty" is scored as 1 and "unable" is scored as 5 points. At least 10 of the 11 items must be answered. The final score is calculated from zero (no disability) to 100 (severe disability). Two optional items of the Quick DASH (work, and sports or music) were not used in this study.

Trial Locations

Locations (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Turkey