- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03000205
Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients
April 13, 2023 updated by: Taipei Medical University Shuang Ho Hospital
Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients: Analysis of Clinical and Sonographic Presentation
Using hypertonic dextrose water for chronic supraspinatus tendinosis and using ultrasound as assessment tool to evaluate the effect of intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ShihWei Huang
- Phone Number: 1606 +88622490088
- Email: 13001@s.tmu.edu.tw
Study Locations
-
-
Zhonghe Dist
-
New taipei city, Zhonghe Dist, Taiwan, 235
- Shuang Ho Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hypertonic dextrose water
20% hypertonic dextrose water injection for chronic shoulder spin
|
20% hypertonic dextrose water injection for chronic shoulder pain at Week0
Other Names:
|
Placebo Comparator: Normal Saline
normal saline and Lidocaine as placebo for sham group
|
Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
Time Frame: Week0 Week2 Week6 Week12
|
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
Time Frame: Week0 Week2 Week6 Week12
|
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)
Time Frame: Week0 Week2 Week6 Week12
|
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)
Time Frame: Week0 Week2 Week6 Week12
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
December 19, 2016
First Posted (Estimate)
December 21, 2016
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 13, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Tendon Injuries
- Arthralgia
- Tendinopathy
- Shoulder Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- N201605022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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