Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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20% hypertonic dextrose water injection group

echo guide 20% dextrose water 3ml was injection in lesion site

Group Type EXPERIMENTAL

hypertonic dextrose water

Intervention Type DRUG

20% hypertonic dextrose water injection for chronic shoulder pain

Steroid injection group

Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide.

Intervention Type DRUG

Triamcinolone Acetonide 40mg/1ml injection

Interventions

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hypertonic dextrose water

20% hypertonic dextrose water injection for chronic shoulder pain

Intervention Type DRUG

Triamcinolone Acetonide.

Triamcinolone Acetonide 40mg/1ml injection

Intervention Type DRUG

Other Intervention Names

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Prolotherapy group comparatice group

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No