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Clinical Trials/NCT06220643
NCT06220643
Completed
Not Applicable

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

Taipei Medical University Shuang Ho Hospital1 site in 1 country60 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
triamcinolone acetonide plus lidocaine
Conditions
Shoulder Bursitis
Sponsor
Taipei Medical University Shuang Ho Hospital
Enrollment
60
Locations
1
Primary Endpoint
Shoulder Pain and Disability Index (SPADI)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Responsible Party
Principal Investigator
Principal Investigator

ShihWei Huang

Attending Physician

Taipei Medical University Shuang Ho Hospital

Eligibility Criteria

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

Arms & Interventions

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

Intervention: triamcinolone acetonide plus lidocaine

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

Intervention: resistance exercise

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

Intervention: triamcinolone acetonide plus lidocaine

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

  • pain free range of motion(Day 0, Month 1, Month 3)

Study Sites (1)

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