Steroid Injection with Exercise for Subacromial Bursitis

January 16, 2025 updated by: ShihWei Huang, Taipei Medical University Shuang Ho Hospital

Prognosis and Effects of Ultrasound Guide Corticosteroid Injection with Progressive Resistance Exercise for Subacromial Bursitis: a Randomized Clinical Trial

Shoulder issues in middle-aged and elderly folks often stem from muscle and tendon degeneration, causing pain and limited movement. Current treatments like corticosteroid injections provide short-term relief for synovial bursitis, prompting repetitive injections. Combining these injections with resistance exercises, especially elastic bands, might extend relief. A study aims to test this by giving injections and a 12-week elastic band exercise program to one group, compared to injections alone in another. Assessments at 4, and 12 weeks post-injection will measure pain, motion, and functionality. Successful results could redefine treatment, reducing repetitive injections and enhancing life quality for those with shoulder problems.

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

Shoulder activities are common among middle-aged and elderly individuals, often leading to degeneration of shoulder muscles and tendons. This degeneration causes instability, resulting in shoulder impingement syndrome and subsequent inflammation of the synovial bursa. Acute synovial bursitis leads to severe shoulder pain, limited movement, affecting daily life and work. Initial treatments like physical therapy and oral medication often fall short, necessitating corticosteroid injections into the subacromial bursa guided by ultrasound for effective relief. However, these injections often provide only short-term relief, leading to a need for repeated injections, causing concerns about side effects.

Previous research indicates that resistance-based exercises improve muscle strength and reduce shoulder tissue damage. Among these exercises, elastic band workouts are deemed safest for the elderly. Despite advancements in ultrasound-guided injections for subacromial bursitis, there's a scarcity of studies combining corticosteroid injections with progressive shoulder resistance exercises to prolong therapeutic effects.

This study aims to explore if progressive resistance exercises enhance and sustain the clinical benefits of ultrasound-guided corticosteroid injections in subacromial bursitis. It's a randomized double-single-blind study wherein the experimental group receives ultrasound-guided injections of 40mg triamcinolone acetonide and 2cc lidocaine into the inflamed bursa and undergoes a 12-week course of elastic band progressive resistance exercises. The control group only receives ultrasound-guided injections. Evaluators remain unaware of the group assignments. Parameters like VAS , ROM, and SPADI are assessed at 4, and 12 weeks post-injection.

This research seeks to ascertain whether combining corticosteroid injections with progressive resistance exercises prolongs the efficacy of treatment for subacromial bursitis. If successful, it could offer a novel approach to managing this condition, potentially reducing the need for repeated injections and improving the overall quality of life for middle-aged and elderly individuals affected by shoulder issues.

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.
Interventional

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.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Taiwan
    • Zhonghe Dist
      • New taipei city, Zhonghe Dist, Taiwan, 235
        • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of subacromial bursitis of shoulder

Exclusion Criteria:

  • history of shoulder shoulder and operation history
  • comorbid with adhesive capsulitis or rotator cuff tear
  • received local injection of shoulder with steroid, hypertonic dextrose, hyaluronic acid or platelet-rich plasma in recent 6 months

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Echoguide steroid injection without exercise (only education)
received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance
Drug: triamcinolone acetonide plus lidocaine
40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%)
Other Names:
  • exercise education
Experimental: Echoguide steroid injection with exercise
experimental group received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance, and a 12-week elastic band progressive resistance exercise
Drug: triamcinolone acetonide plus lidocaine
40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%)
Other Names:
  • exercise education
Other: resistance exercise
Progressive resistance exercise for 12 weeks

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
Shoulder Pain and Disability Index (SPADI)
Time Frame: Day 0, Month 1, Month 3
The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.
Day 0, Month 1, Month 3
Visual Analogue Scale (VAS)
Time Frame: Day 0, Month 1, Month 3
pain score from 0~10, 0 means no pain, and 10 means extreme pain
Day 0, Month 1, Month 3

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
pain free range of motion
Time Frame: Day 0, Month 1, Month 3
Shoulder range of motion of flexion, extension, abduction, internal rotation, external rotation
Day 0, Month 1, Month 3

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.
Taipei Medical University Shuang Ho 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.
January 1, 2024

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.
December 31, 2024

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.
December 31, 2024

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).
December 14, 2023

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.
January 23, 2024

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.
January 24, 2024

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 25, 2025

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.
January 16, 2025

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.
December 1, 2023

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.
  • N202306022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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