Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
Overview
- Phase
- Not Applicable
- Intervention
- hypertonic dextrose water
- Conditions
- Chronic Shoulder Pain
- Sponsor
- Taipei Medical University Shuang Ho Hospital
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
- Last Updated
- 4 years ago
Overview
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.
Investigators
ShihWei Huang
Attending Physician
Taipei Medical University Shuang Ho Hospital
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.
Arms & Interventions
20% hypertonic dextrose water injection group
echo guide 20% dextrose water 3ml was injection in lesion site
Intervention: hypertonic dextrose water
Steroid injection group
Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group
Intervention: Triamcinolone Acetonide.
Outcomes
Primary Outcomes
Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
Time Frame: Week0 Week2 Week6 Week12
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 Outcomes
- Shoulder ROM (Range of Motion)(Week0 Week2 Week6 Week12)
- Pain (VAS, Visual Analogue Scale)(Week0 Week2 Week6 Week12)
- Ultrasound(Week0 Week2 Week6 Week12)