search
Back to results

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

Primary Purpose

Subacromial Bursitis, Subacromial Impingement Syndrome, Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Triamcinolone SASD injection
Physiotherapy
Triamcinolone injections & Physiotherapy
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Bursitis focused on measuring subacromial bursitis, subacromial impingement syndrome, corticosteroid, physical therapy, therapeutic exercise, rehabilitation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Triamcinolone SASD injection

Physiotherapy

Triamcinolone injections & Physiotherapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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 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).
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.

Full Information

First Posted
September 6, 2018
Last Updated
November 14, 2022
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
National Science Council, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT03871465
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Bursitis, Subacromial Impingement Syndrome, Physical Therapy, Therapeutic Exercise, Rehabilitation
Keywords
subacromial bursitis, subacromial impingement syndrome, corticosteroid, physical therapy, therapeutic exercise, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triamcinolone SASD injection
Arm Type
Experimental
Arm Description
2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
Arm Title
Physiotherapy
Arm Type
Experimental
Arm 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.
Arm Title
Triamcinolone injections & Physiotherapy
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone SASD injection
Intervention Description
2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone injections & Physiotherapy
Intervention 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.
Primary Outcome Measure Information:
Title
The pain VAS score
Description
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.
Time Frame
change between baseline and at 8 weeks after the beginning of the treatment.
Title
The scores of the Shoulder Pain and Disability Index (SPADI)
Description
The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
Time Frame
change between baseline and at 8 weeks after the beginning of the treatment.
Secondary Outcome Measure Information:
Title
The active ROM
Description
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.
Time Frame
change between baseline and at 8 weeks after the beginning of the treatment.
Title
Change of the Shoulder Disability Questionnaire (SDQ)
Description
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).
Time Frame
change between baseline and at 8 weeks after the beginning of the treatment.
Title
The Western Ontario Rotator Cuff Index (WORC).
Description
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.
Time Frame
change between baseline and at 8 weeks after the beginning of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs