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NCT Number: NCT03871465

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).

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Key information

Conditions

Subacromial Bursitis Joint Diseases Musculoskeletal Diseases Physical Therapy Rehabilitation Shoulder Impingement Syndrome Shoulder Injuries Subacromial Impingement Syndrome Therapeutic Exercise Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • shoulder pain for more than 1 month
  • age ≥20 years old
  • painful abduction or internal rotation with a visual analog scale (VAS) pain score ≥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
  • positive shoulder impingement test (Neer test and/or Hawkin test)
  • 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

  • a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and serious infection
  • previous surgery of the affected shoulder
  • any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests andsonographic findings
  • calcification of the rotator cuff, demonstrated by x-ray or sonographic findings
  • 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
  • the presence of instability of the affected shoulder
  • a previous fracture near the shoulder region
  • the presence of cervical radiculopathy or myelopathy
  • having received a corticosteroid or hyaluronic acid subacromial or shoulder joint injection in the past 3 months.

Treatment and study plan

Triamcinolone SASD injection

Drug

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

physiotherapy

Procedure

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.

Triamcinolone injections & Physiotherapy

Drug

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.

Primary outcomes

  1. The pain VAS score

    Time frame: change between baseline and at 8 weeks after the beginning of the treatment.

    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.

  2. The scores of the Shoulder Pain and Disability Index (SPADI)

    Time frame: change between baseline and at 8 weeks after the beginning of the treatment.

    The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.

Secondary outcomes

  1. The active ROM

    Time frame: change between baseline and at 8 weeks after the beginning of the treatment.

    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.

  2. Change of the Shoulder Disability Questionnaire (SDQ)

    Time frame: change between baseline and at 8 weeks after the beginning of the treatment.

    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).

  3. The Western Ontario Rotator Cuff Index (WORC).

    Time frame: change between baseline and at 8 weeks after the beginning of the treatment.

    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.

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2019
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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