Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients

Study Overview
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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.

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.

Official Title
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Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients: Analysis of Clinical and Sonographic Presentation

Conditions
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Chronic Shoulder Pain

Intervention / Treatment
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* Device: hypertonic dextrose water
* Device: Normal saline and Lidocaine.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypertonic dextrose water<br>20% hypertonic dextrose water injection for chronic shoulder spin | Device: hypertonic dextrose water<br>* 20% hypertonic dextrose water injection for chronic shoulder pain at Week0<br>* Other names: Prolotherapy group;|
| Placebo Comparator: Normal Saline<br>normal saline and Lidocaine as placebo for sham group | Device: Normal saline and Lidocaine.<br>* Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week0 Week2 Week6 Week12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound | The ultrasound evaluated the status of the biceps and supraspinatus patency was evaluated using both longitudinal and transverse views. The findings of the ultrasound examinations were classified as either normal or abnormal (tear or tendonitis). A tear was defined as a discontinuity in the normal homogeneous echogenicity of the tendon, whereas tendonitis was defined as a thickening or hypoechogenicity of the tendon in the absence of a border defect. The diagnostic criteria of biceps tenosynovitis was defined as tendon sheath fluid accumulation (abnormal hypoechoic or anechoic accumulation relative to subdermal fat; occasionally isoechoic or hyperechoic) in intra-articular material that is displaceable and compressible at ≥ 3 mm. | Week0 Week2 Week6 Week12 | 
| 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. | Week0 Week2 Week6 Week12 | 
| 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. | Week0 Week2 Week6 Week12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dextrose prolotherapy, patients