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

S

Shin Kong Wu Ho-Su Memorial Hospital

Status

Completed

Conditions

Rehabilitation
Subacromial Bursitis
Therapeutic Exercise
Physical Therapy
Subacromial Impingement Syndrome

Treatments

Drug: Triamcinolone SASD injection
Drug: Triamcinolone injections & Physiotherapy
Procedure: Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03871465
NSTC 108-2314-B-341-002 (Other Grant/Funding Number)
20171205R
NSTC 107-2314-B-341-002 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

111 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

111 participants in 3 patient groups

Triamcinolone SASD injection
Experimental group
Description:
2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
Treatment:
Drug: Triamcinolone SASD injection
Physiotherapy
Experimental group
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.
Treatment:
Procedure: Physiotherapy
Triamcinolone injections & Physiotherapy
Experimental group
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.
Treatment:
Drug: Triamcinolone injections & Physiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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