Steroid Injection with Exercise for Subacromial Bursitis

NCT ID: NCT06220643

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Shoulder Bursitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

triamcinolone acetonide plus lidocaine

Intervention Type: DRUG

40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%)

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

Group Type: EXPERIMENTAL

resistance exercise

Intervention Type: OTHER

Progressive resistance exercise for 12 weeks

triamcinolone acetonide plus lidocaine

Intervention Type: DRUG

40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%)

Interventions

resistance exercise

Progressive resistance exercise for 12 weeks

Intervention Type: OTHER

triamcinolone acetonide plus lidocaine

40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%)

Intervention Type: DRUG

Other Intervention Names

exercise education

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

ShihWei Huang

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, Zhonghe Dist, Taiwan

Countries

Taiwan

Other Identifiers

N202306022

Identifier Type: -

Identifier Source: org_study_id