Clinical trial NCT04916353: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Shoulder Pain
Keywords: Prolotherapy
subacromial bursitis
ultrasound
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
timeFrame: Week0 Week2 Week6 Week12
Secondary outcomes:
measure: Ultrasound
timeFrame: Week0 Week2 Week6 Week12
measure: Shoulder ROM (Range of Motion)
timeFrame: Week0 Week2 Week6 Week12
measure: Pain (VAS, Visual Analogue Scale)
timeFrame: Week0 Week2 Week6 Week12
Other outcomes:
Locations:
city: New taipei city
country: Taiwan
facility: Shuang Ho Hospital
state: Zhonghe Dist
city: New taipei city
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
state: Zhonghe Dist
Study officials:
affiliation: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
name: Lien-Chieh Lin
role: STUDY_CHAIR
References: