Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-10-31

Brief Summary

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Using hypertonic dextrose water for chronic supraspinatus tendinosis and using ultrasound as assessment tool to evaluate the effect of intervention.

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Detailed Description

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Supraspinatus tendinosis is a degenerative process of tendon. It can be caused by external trauma episode and imbalanced of self-repair process. It can cause patients with shoulder pain when shoulder over head exercise and heavy lifting. It can also influence the sleep quality due to pain symptoms of shoulder. Usually these patients had limited response to medication and physical modality. Moreover, it can cause shoulder tear or rupture, which can disability with aging. Prolotherapy is an injection therapy for chronic painful musculoskeletal conditions. It involves the injection of small volumes of an irritant agent, most commonly a hyperosmolar dextrose solution, at multiple painful tendon and ligament insertions where they connect to bone, over several treatment sessions. The injection of an irritant solution initiates an inflammatory cascade at the site of injection, which causes fibroblast proliferation and subsequent collagen synthesis, resulting in a stronger tendon or ligament. Hyperosmolar dextrose appears to be the most commonly used agent today, with morrhuate sodium used slightly less often. There is promising recent evidence for prolotherapy, with hyperosmolar dextrose in treating painful tendinopathies. The aim of this study is to hypertonic injection in supraspinatus tendinosis patients about clinical and ultrasound image presentation. We conducted a double blinded randomized controlled trial for 60 participants with chronic shoulder pain for 3 months with supraspinatus tendonsis. In study group, one injection with 20% dextrose water was injection in supraspinatus tendon and control group received normal saline and Lidocaine. SPADI, VAS and ultrasound data were obtained before intervention and 2 weeks, 6 weeks and 12 weeks after injection after intervention. The ANOVA and independent t test are applied for analysis by SPSS 20.0 with 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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hypertonic dextrose water

20% hypertonic dextrose water injection for chronic shoulder spin

Group Type EXPERIMENTAL

hypertonic dextrose water

Intervention Type DEVICE

20% hypertonic dextrose water injection for chronic shoulder pain at Week0

Normal Saline

normal saline and Lidocaine as placebo for sham group

Group Type PLACEBO_COMPARATOR

Normal saline and Lidocaine.

Intervention Type DEVICE

Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)

Interventions

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hypertonic dextrose water

20% hypertonic dextrose water injection for chronic shoulder pain at Week0

Intervention Type DEVICE

Normal saline and Lidocaine.

Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)

Intervention Type DEVICE

Other Intervention Names

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Prolotherapy group Control 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 rupture 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