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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871465
• Other study ID #: 20171205R
• Secondary ID: NSTC 107-2314-B-
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2022
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bursitis
• Physical Therapy
• Rehabilitation
• Shoulder Impingement Syndrome
• Subacromial Bursitis
• Subacromial Impingement Syndrome
• Therapeutic Exercise

Intervention

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

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pain VAS score	The pain VAS score is obtained using a 100-mm-long horizontal line, with 0 mm on the left indicating no pain and 100 mm on the right indicating very severe pain.	change between baseline and at 8 weeks after the beginning of the treatment.
Primary	The scores of the Shoulder Pain and Disability Index (SPADI)	The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.	change between baseline and at 8 weeks after the beginning of the treatment.
Secondary	The active ROM	The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.	change between baseline and at 8 weeks after the beginning of the treatment.
Secondary	Change of the Shoulder Disability Questionnaire (SDQ)	The SDQ is a symptoms-related questionnaire containing 16 items describing common situations that may induce symptoms in patients with shoulder disorders. By responding 'yes', 'no', or 'not applicable', the final score is obtained by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst situation).	change between baseline and at 8 weeks after the beginning of the treatment.
Secondary	The Western Ontario Rotator Cuff Index (WORC).	It is composed of 5 subscales: physical symptoms, sports/recreation, work, lifestyle, and emotions. Each item has a score range of 0 to 100.Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.	change between baseline and at 8 weeks after the beginning of the treatment.