Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-04-05 @ 5:15 AM
Study NCT ID:
NCT03000205
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2016-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients
Sponsor:
Taipei Medical University Shuang Ho Hospital
Organization:
Study Overview
Official Title:
Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients: Analysis of Clinical and Sonographic Presentation
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Using hypertonic dextrose water for chronic supraspinatus tendinosis and using ultrasound as assessment tool to evaluate the effect of intervention.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: