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Effect of Ultrasound-guided Hyaluronic or Corticosteroid Injections in Patients With Chronic Subacromial Bursitis

Primary Purpose

Shoulder Pain, Subdeltoid Bursitis, Subacromial Bursitis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
corticosteroids
hyaluronic acid
normal saline
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 Shoulder Pain focused on measuring Shoulder pain, subdeltoid bursitis, subacromial bursitis, intra-bursa injection

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 a soft end feel
  5. tenderness over the subacromial bursa
  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 ultrasound (US) guidance.

Exclusion Criteria:

  1. a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and infection
  2. previous surgery of the affected shoulder
  3. any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests or sonographic findings
  4. calcification of the rotator cuff, demonstrated by x-ray or sonographic findings
  5. the presence of arthritis, such as inflammatory arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathy, 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

Placebo Comparator

Arm Label

corticosteroids SASD injection

hyaluronic acid (ARTZ) SASD injection

normal saline SASD injection

Arm Description

under US guidance 2ml triamcinolone (1ml/10mg), 0.5ml distilled water and 1ml 1% lidocaine

under US guidance 2.5ml HA (ARTZ, 1% sodium hyaluronate solution, 10mg/mL, molecular weight 0.9x106Da) and 1ml 1% lidocaine

under US guidance 2.5ml normal saline and 0.5ml distilled water and 1ml 1% lidocaine

Outcomes

Primary Outcome Measures

Change from baseline VAS pain score
The VAS scores for pain were 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.

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 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 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).
Change of 36-item Short-Form Health Survey (SF-36)
The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5).

Full Information

First Posted
November 18, 2014
Last Updated
December 22, 2020
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02702206
Brief Title
Effect of Ultrasound-guided Hyaluronic or Corticosteroid Injections in Patients With Chronic Subacromial Bursitis
Official Title
Effect of Ultrasound-guided Hyaluronic or Corticosteroid Injections in Patients With Chronic Subacromial Bursitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized controlled trial to compare the effect of ultrasound-guided hyaluronic or corticosteroid injections in patients with chronic subacromial bursitis.
Detailed Description
Chronic subacromial bursitis (SAB) is a common shoulder disorder characterized by chronic shoulder pain with a painful arc of motion, which commonly occurs during abduction and sometimes during internal rotation of the shoulder. In addition, the extremes of all passive movements are painful. The range of motion (ROM) of the shoulder is usually not limited or is limited in a non-capsular pattern (mainly abduction and internal rotation). All resisted movements are painless or equally painful, and there is also tenderness over the deltoid region. The diagnosis of SAB remains doubtful until it is confirmed by an infiltration with local anesthetic. The injections can be performed by palpation (using anatomical landmarks to place the needle) or with ultrasound (US) guidance (with visualization of the needle tip at the target location). The chief advantage of an ultrasound-guided intervention is the ability to use real-time, dynamic imaging without ionizing radiation. Previous studies have demonstrated that ultrasound-guided injection ensures correct needle placement and delivery of the medicine to the target, and improved clinical outcomes with ultrasound-guided subacromial-subdeltoid (SASD) corticosteroid injections. Although SASD corticosteroid injections has been proven effective in treatment of chronic subacromial bursitis, in clinical practice, some patients fear the side effects of the corticosteroids. In the last few years, hyaluronic acid (HA) injection has been used for treatment of different kinds of shoulder disorders, including subacromial impingement syndrome, frozen shoulder, and rotator cuff tears, with variable results. However, treatment of chronic SAB with hyaluronic acid has never been reported before. Besides, some authors used combination of normal saline and lidocain as the placebo, which might not be a true placebo because lidocain can be an active medicine. Therefore, the purpose of this study is to compare the effectiveness of SASD corticosteroid, HA, and normal saline injection in treatment of patients with chronic SAB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Subdeltoid Bursitis, Subacromial Bursitis
Keywords
Shoulder pain, subdeltoid bursitis, subacromial bursitis, intra-bursa injection

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
corticosteroids SASD injection
Arm Type
Experimental
Arm Description
under US guidance 2ml triamcinolone (1ml/10mg), 0.5ml distilled water and 1ml 1% lidocaine
Arm Title
hyaluronic acid (ARTZ) SASD injection
Arm Type
Experimental
Arm Description
under US guidance 2.5ml HA (ARTZ, 1% sodium hyaluronate solution, 10mg/mL, molecular weight 0.9x106Da) and 1ml 1% lidocaine
Arm Title
normal saline SASD injection
Arm Type
Placebo Comparator
Arm Description
under US guidance 2.5ml normal saline and 0.5ml distilled water and 1ml 1% lidocaine
Intervention Type
Drug
Intervention Name(s)
corticosteroids
Other Intervention Name(s)
triamcinolone
Intervention Description
under US guidance, 2ml triamcinolone (1ml/10mg), 0.5ml distilled water and 1ml 1% lidocaine
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid
Other Intervention Name(s)
ARTZ
Intervention Description
under US guidance, 2.5ml HA (ARTZ, 1% sodium hyaluronate solution, 10mg/mL, molecular weight 0.9x106Da) and 1ml 1% lidocaine
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
placebo group
Intervention Description
under US guidance, 2.5ml normal saline (placebo group). 0.5ml distilled water and 1ml 1% lidocaine
Primary Outcome Measure Information:
Title
Change from baseline VAS pain score
Description
The VAS scores for pain were 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
baseline and 2 weeks
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
between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks
Title
Change of 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
between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks
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
between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks
Title
Change of 36-item Short-Form Health Survey (SF-36)
Description
The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5).
Time Frame
between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks

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 a soft end feel tenderness over the subacromial bursa 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 ultrasound (US) guidance. Exclusion Criteria: a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and infection previous surgery of the affected shoulder any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests or sonographic findings calcification of the rotator cuff, demonstrated by x-ray or sonographic findings the presence of arthritis, such as inflammatory arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathy, 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, M.D
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

Citations:
PubMed Identifier
33858205
Citation
Hsieh LF, Lin YJ, Hsu WC, Kuo YC, Liu YC, Chiang YP, Wang CP. Comparison of the corticosteroid injection and hyaluronate in the treatment of chronic subacromial bursitis: A randomized controlled trial. Clin Rehabil. 2021 Sep;35(9):1305-1316. doi: 10.1177/02692155211007799. Epub 2021 Apr 15.
Results Reference
derived

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Effect of Ultrasound-guided Hyaluronic or Corticosteroid Injections in Patients With Chronic Subacromial Bursitis

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