Skip to main content
OpenTrials
Completed

NCT Number: NCT05266391

Injection Technique 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subacromial Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Shoulder posterolateral pain that increased with shoulder abduction,
  • Restriction of the shoulder passive and active range of motion (ROM),
  • Patients with positive Neer and Hawkins impingement test,
  • Patients with SAIS whose diagnosis was confirmed by magnetic resonance imaging (MRI), and
  • 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.

Treatment and study plan

subacromial corticosteroid injections

Other

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).

Primary outcomes

  1. Visual analogue scale (VAS)

    Time frame: 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 outcomes

  1. Shoulder joint range of motion (ROM)

    Time frame: 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

  2. Shoulder Pain and Disability Index (SPADI)

    Time frame: 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

  3. The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: SAIS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2022
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.