Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients

Chronic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000205
• Other study ID #: N201605022
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2022
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Shoulder Pain
• Shoulder Pain
• Tendinopathy

Intervention

Device:
• hypertonic dextrose water
20% hypertonic dextrose water injection for chronic shoulder pain at Week0
• Normal saline and Lidocaine.
Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital	New taipei city	Zhonghe Dist

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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