Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
Primary Purpose
Chronic Shoulder Pain
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
hypertonic dextrose water
Triamcinolone Acetonide.
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Shoulder Pain focused on measuring Prolotherapy, subacromial bursitis, ultrasound
Eligibility Criteria
Inclusion Criteria:
- Aged more than 20 years old with diagnosis of chronic supraspinatus tendinosis by ultrasound and clinical shoulder pain lasting for more than 3 months.
Exclusion Criteria:
- History of shoulder fracture and operation, with frozen shoulder or full thickness ruptur of rotator cuff, steroid, or hyaluronic acid, or platelet rich plasma (PRP) injection during the period of intervention and following up.
Sites / Locations
- Shuang Ho Hospital
- Taipei Medical University-Shuang Ho Hospital,Ministry of Health and WelfareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
20% hypertonic dextrose water injection group
Steroid injection group
Arm Description
echo guide 20% dextrose water 3ml was injection in lesion site
Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group
Outcomes
Primary Outcome Measures
Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
Shoulder Pain and Disability Index (SPADI), a self-administered assessment tool that was used to measure pain and disability related to shoulder disease. The SPADI consists of 5 pain and 8 disability items that are measured on a visual analog scale. Pain and disability subscales were calculated as the mean of the corresponding items on a 0-100 scale; the highest score indicated the most severe pain and disability. The total outcome score used for statistical analysis was calculated as the sum of the pain and disability subscales.
Secondary Outcome Measures
Ultrasound
The ultrasound evaluated the thickness of subarcomial bursa
Shoulder ROM (Range of Motion)
Pain-free passive range of motion (PROM) of the shoulder was designated as the range of motion attained at the most painful position and was measured using a digital goniometer in 6 directions flexion, extension, abduction, adduction, external rotation and internal rotation. Five directions of the shoulder joint were measured (flexion, abduction, adduction, internal rotation, and external rotation) while participants were lying in a supine position. Additionally, shoulder extension was measured in the side-lying position.
Pain (VAS, Visual Analogue Scale)
Shoulder pain was assessed according to an 11-point numerical rating scale (NRS). This tool was simple to use and was highly correlated with the visual analog scale, verbal rating scale, and Faces Pain Scale-Revised. The NRS is considered a valid and reliable pain assessment tool. The pain intensity was graded from 0 (no pain) to 10 (the most intense level of pain). The participants reported their pain level at rest and during the movement of shoulder joint in all direction. The most painful movement score was used for further data analysis.
Full Information
NCT ID
NCT04916353
First Posted
June 2, 2021
Last Updated
September 2, 2021
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04916353
Brief Title
Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
Official Title
Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the echoguide hypertonic injection and compared steroid injection in subacromial bursitis patients about clinical and ultrasound image presentation.
Detailed Description
Subacromial bursitis is one of the major causes of chronic refractory shoulder pain. It can cause patients with shoulder pain when shoulder exercise and heavy lifting and limiting the range of motion. It can also influence the sleep quality due to pain symptoms of the shoulder. Usually, these patients had limited response to medication and physical modality. Steroid injection was often adopted for intervention, but the adverse effects should be considered. Therefore, prolotherapy was taken as an alternative treatment for chronic subacromial bursitis. It involves the injection of small volumes of an irritant agent, most commonly a hyperosmolar dextrose solution, at the lesion site. Hyperosmolar dextrose appears to be the most commonly used agent today. The aim of this study is to investigate hypertonic injections in subacromial bursitis patients about clinical and ultrasound image presentation. The investigators conducted a double-blinded randomized controlled trial for 60 participants with chronic shoulder pain for 3 months with subacromial bursitis. In the study group, the echo guide 20% dextrose water was injected into the lesion site, and the control group received the echo guide steroid injection. ROM, SPADI, VAS, x-ray, and ultrasound data were obtained at baseline. At weeks 2, 6, 12, ROM, SPADI, VAS, and ultrasound data were evaluated. The ANOVA and independent t-test are applied for analysis by SPSS 20.0 with a P value less than 0.05 as statistical significance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Shoulder Pain
Keywords
Prolotherapy, subacromial bursitis, ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
20% hypertonic dextrose water injection group
Arm Type
Experimental
Arm Description
echo guide 20% dextrose water 3ml was injection in lesion site
Arm Title
Steroid injection group
Arm Type
Active Comparator
Arm Description
Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group
Intervention Type
Drug
Intervention Name(s)
hypertonic dextrose water
Other Intervention Name(s)
Prolotherapy group
Intervention Description
20% hypertonic dextrose water injection for chronic shoulder pain
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide.
Other Intervention Name(s)
comparatice group
Intervention Description
Triamcinolone Acetonide 40mg/1ml injection
Primary Outcome Measure Information:
Title
Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
Description
Shoulder Pain and Disability Index (SPADI), a self-administered assessment tool that was used to measure pain and disability related to shoulder disease. The SPADI consists of 5 pain and 8 disability items that are measured on a visual analog scale. Pain and disability subscales were calculated as the mean of the corresponding items on a 0-100 scale; the highest score indicated the most severe pain and disability. The total outcome score used for statistical analysis was calculated as the sum of the pain and disability subscales.
Time Frame
Week0 Week2 Week6 Week12
Secondary Outcome Measure Information:
Title
Ultrasound
Description
The ultrasound evaluated the thickness of subarcomial bursa
Time Frame
Week0 Week2 Week6 Week12
Title
Shoulder ROM (Range of Motion)
Description
Pain-free passive range of motion (PROM) of the shoulder was designated as the range of motion attained at the most painful position and was measured using a digital goniometer in 6 directions flexion, extension, abduction, adduction, external rotation and internal rotation. Five directions of the shoulder joint were measured (flexion, abduction, adduction, internal rotation, and external rotation) while participants were lying in a supine position. Additionally, shoulder extension was measured in the side-lying position.
Time Frame
Week0 Week2 Week6 Week12
Title
Pain (VAS, Visual Analogue Scale)
Description
Shoulder pain was assessed according to an 11-point numerical rating scale (NRS). This tool was simple to use and was highly correlated with the visual analog scale, verbal rating scale, and Faces Pain Scale-Revised. The NRS is considered a valid and reliable pain assessment tool. The pain intensity was graded from 0 (no pain) to 10 (the most intense level of pain). The participants reported their pain level at rest and during the movement of shoulder joint in all direction. The most painful movement score was used for further data analysis.
Time Frame
Week0 Week2 Week6 Week12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged more than 20 years old with diagnosis of chronic supraspinatus tendinosis by ultrasound and clinical shoulder pain lasting for more than 3 months.
Exclusion Criteria:
History of shoulder fracture and operation, with frozen shoulder or full thickness ruptur of rotator cuff, steroid, or hyaluronic acid, or platelet rich plasma (PRP) injection during the period of intervention and following up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ShihWei Huang
Phone
+88622490088
Ext
1601
Email
13001@s.tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lien-Chieh Lin
Organizational Affiliation
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
Official's Role
Study Chair
Facility Information:
Facility Name
Shuang Ho Hospital
City
New taipei city
State/Province
Zhonghe Dist
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
City
New taipei city
State/Province
Zhonghe Dist
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ShihWei Huang
Phone
+88622490088
Ext
1601
Email
13001@s.tmu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
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