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

NCT03871465 | Completed DMC

• 3 other identifiers: 20171205RNSTC 107-2314-B-341-002NSTC 108-2314-B-341-002
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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).

Conditions

Subacromial Bursitis; Subacromial Impingement Syndrome; Physical Therapy; Therapeutic Exercise; Rehabilitation

Keywords

subacromial bursitis; subacromial impingement syndrome; corticosteroid; physical therapy; therapeutic exercise; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The active ROM

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

• Change of the Shoulder Disability Questionnaire (SDQ)

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

• The Western Ontario Rotator Cuff Index (WORC).

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

Study Arms (3)

Triamcinolone SASD injection

EXPERIMENTAL

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

Drug: Triamcinolone SASD injection

Physiotherapy

EXPERIMENTAL

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

Triamcinolone injections & Physiotherapy

EXPERIMENTAL

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

Interventions

Triamcinolone SASD injection DRUG

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

Triamcinolone SASD injection

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.

Physiotherapy

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.

Triamcinolone injections & Physiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Lin-Fen Hsieh

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: March 12, 2019
• Study Start: August 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

TW (1)