Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis

NCT ID: NCT03871465

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-07-31

Brief Summary

This study is to investigate whether combination of ultrasound-guided subdeltoidcorticosteroid injection and physiotherapy is more effective than either treatment alone in treatment of patients with chronic subacromial (or subdeltoid) bursitis (SAB).

Detailed Description

Chronic subacromial bursitis (SAB) is a common shoulder disorder characterized by chronic shoulder pain with a painful arc of motion, and/or pain on active or passive motions. The diagnosis of SAB requires confirmation by an infiltration with local anesthetic. Previous study showed that corticosteroid injection is more effective than hyaluronic acid in treatment of chronic SAB, however, some (about 20%) patients were not responsive to corticosteroid injection, and some responsive patients may have recurrence of symptoms. The purpose of this study is to investigate whether combination of corticosteroids SASD injections and physiotherapy is more effective than either treatment alone in chronic SAB.

Conditions

Subacromial Bursitis; Subacromial Impingement Syndrome; Physical Therapy; Therapeutic Exercise; Rehabilitation

Study Design

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

Study Groups

Triamcinolone SASD injection

2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.

Group Type: EXPERIMENTAL

Triamcinolone SASD injection

Intervention Type: DRUG

2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.

Physiotherapy

The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: PROCEDURE

The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.

Triamcinolone injections & Physiotherapy

2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.

The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.

Group Type: EXPERIMENTAL

Triamcinolone injections & Physiotherapy

Intervention Type: DRUG

2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.

The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.

Interventions

Triamcinolone SASD injection

2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.

Intervention Type: DRUG

Physiotherapy

The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.

Intervention Type: PROCEDURE

Triamcinolone injections & Physiotherapy

2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.

The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. shoulder pain for more than 1 month

2. age ≥20 years old

3. painful abduction or internal rotation with a visual analog scale (VAS) pain score ≥4

4. the presence of a painful arc of motion or pain at the middle to terminal range of shoulder abduction or internal rotation with an empty or soft end feel

5. positive shoulder impingement test (Neer test and/or Hawkin test)

6. a reduction in pain of ≥40% on active shoulder abduction or internal rotation at the terminal range after injection of 3ml of 1%lidocain into the SASD bursa under US guidance.

Exclusion Criteria

1. a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and serious infection

2. previous surgery of the affected shoulder

3. any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests andsonographic findings

4. calcification of the rotator cuff, demonstrated by x-ray or sonographic findings

5. the presence of arthritis, such asinflammatory arthritis(e.g., rheumatoid arthritis, seronegativespondyloarthropathy, or crystal-related arthropathy), osteoarthritis, frozen shoulder, subacromial spurs, or deformity of the acromion

6. the presence of instability of the affected shoulder

7. a previous fracture near the shoulder region

8. the presence of cervical radiculopathy or myelopathy

9. having received a corticosteroid or hyaluronic acid subacromial or shoulder joint injection in the past 3 months.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lin-Fen Hsieh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin-Fen Hsieh

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

NSTC 107-2314-B-341-002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NSTC 108-2314-B-341-002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20171205R

Identifier Type: -

Identifier Source: org_study_id