Injection Technique in Subacromial Impingement Syndrome (SAIS)

Comparison of Clinical Results of Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections in Subacromial Impingement Syndrome

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).

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Other: subacromial corticosteroid injections

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34186
    • Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; patients who received US-guided subacromial corticosteroid injections	Other: subacromial corticosteroid injections; 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).
group 2; patients who underwent blind subacromial corticosteroid injections	Other: subacromial corticosteroid injections; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS)	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	Change from baseline visual analogue scale score at 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder joint range of motion (ROM)	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	Change from baseline Shoulder joint range of motion at 1 month
Shoulder Pain and Disability Index (SPADI)	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	Change from baseline Shoulder Pain and Disability Index at 1 month
The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH)	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.	Change from baseline The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire at 1 month

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Study Chair: Kadriye Ones, Prof, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: PMRTURKEY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: results and conclusions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No