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

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).

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome; Rehabilitation; Physical Therapy; Subacromial Bursitis; Therapeutic Exercise
• Intervention / Treatment: Drug: Triamcinolone SASD injection; Procedure: Physiotherapy; Drug: Triamcinolone injections & Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triamcinolone SASD injection; 2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.	Drug: Triamcinolone SASD injection; 2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Collaborators: National Science Council, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; physical therapy; corticosteroid; therapeutic exercise; subacromial impingement syndrome; subacromial bursitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Shoulder Impingement Syndrome; Bursitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 20171205R; NSTC 107-2314-B-341-002 (Other Grant/Funding Number: National Science and Technology Council); NSTC 108-2314-B-341-002 (Other Grant/Funding Number: National Science and Technology Council)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No