Clinical trial NCT03871465: Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis
Official title: Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Bursitis
Subacromial Impingement Syndrome
Physical Therapy
Therapeutic Exercise
Rehabilitation
Keywords: subacromial bursitis
subacromial impingement syndrome
corticosteroid
physical therapy
therapeutic exercise
rehabilitation
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2019-03-12
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The pain VAS score
timeFrame: change between baseline and at 8 weeks after the beginning of the treatment.
measure: The scores of the Shoulder Pain and Disability Index (SPADI)
timeFrame: change between baseline and at 8 weeks after the beginning of the treatment.
Secondary outcomes:
measure: The active ROM
timeFrame: change between baseline and at 8 weeks after the beginning of the treatment.
measure: Change of the Shoulder Disability Questionnaire (SDQ)
timeFrame: change between baseline and at 8 weeks after the beginning of the treatment.
measure: The Western Ontario Rotator Cuff Index (WORC).
timeFrame: change between baseline and at 8 weeks after the beginning of the treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh
role: PRINCIPAL_INVESTIGATOR
References: