Steroid Injection with Exercise for Subacromial Bursitis

NCT06220643 | Completed DMC

• 1 other identifier: N202306022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Bursitis

Outcome Measures

Primary Outcomes (2)

• Shoulder Pain and Disability Index (SPADI)

  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)

  pain score from 0\~10, 0 means no pain, and 10 means extreme pain

  Day 0, Month 1, Month 3

Secondary Outcomes (1)

• pain free range of motion

  Day 0, Month 1, Month 3

Study Arms (2)

Echoguide steroid injection without exercise (only education)

ACTIVE COMPARATOR

received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance

Drug: triamcinolone acetonide plus lidocaine

Echoguide steroid injection with exercise

EXPERIMENTAL

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

Other: resistance exercise; Drug: triamcinolone acetonide plus lidocaine

Interventions

resistance exercise OTHER

Progressive resistance exercise for 12 weeks

Echoguide steroid injection with exercise

triamcinolone acetonide plus lidocaine DRUG

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

Also known as: exercise education

Echoguide steroid injection with exercise; Echoguide steroid injection without exercise (only education)

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of subacromial bursitis of shoulder

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

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

New Taipei City, Zhonghe Dist, 235, Taiwan

Location

MeSH Terms

Interventions

Resistance Training; Triamcinolone Acetonide; Lidocaine

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 24, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)