Injection Technique in Subacromial Impingement Syndrome (SAIS)

February 28, 2022 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline visual analogue scale score at 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline Shoulder joint range of motion at 1 month
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
Change from baseline Shoulder Pain and Disability Index at 1 month
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.
Change from baseline The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kadriye Ones, Prof, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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