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

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

Sponsors

Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Source Shin Kong Wu Ho-Su Memorial Hospital
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.

Overall Status Recruiting
Start Date August 1, 2018
Completion Date December 31, 2022
Primary Completion Date July 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The pain VAS score change between baseline and at 8 weeks after the beginning of the treatment.
The scores of the Shoulder Pain and Disability Index (SPADI) change between baseline and at 8 weeks after the beginning of the treatment.
Secondary Outcome
Measure Time Frame
The active ROM change between baseline and at 8 weeks after the beginning of the treatment.
Change of the Shoulder Disability Questionnaire (SDQ) change between baseline and at 8 weeks after the beginning of the treatment.
The Western Ontario Rotator Cuff Index (WORC). change between baseline and at 8 weeks after the beginning of the treatment.
Enrollment 105
Condition
Intervention

Intervention type: Drug

Intervention name: Triamcinolone SASD injection

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

Arm group label: Triamcinolone SASD injection

Intervention type: Procedure

Intervention name: Physiotherapy

Description: 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.

Arm group label: Physiotherapy

Intervention type: Drug

Intervention name: Triamcinolone injections & Physiotherapy

Description: 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.

Arm group label: Triamcinolone injections & Physiotherapy

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.

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Lin-Fen Hsieh Principal Investigator Shin Kong Wu Ho-Su Memorial Hospital
Overall Contact

Last name: Lin-Fen Hsieh

Phone: +886-28332211

Phone ext: 2538

Email: [email protected]

Location
facility status contact
Shin Kong Wu Ho-Su Memorial Hospital Recruiting Lin-Fen Hsieh, M.D +886-28332211 2538 [email protected]
Location Countries

Taiwan

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Triamcinolone SASD injection

Arm group type: Experimental

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

Arm group label: Physiotherapy

Arm group type: Experimental

Description: 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.

Arm group label: Triamcinolone injections & Physiotherapy

Arm group type: Experimental

Description: 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov