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Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients

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ClinicalTrials.gov Identifier: NCT03000205
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Shuang Ho Hospital

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

Condition or disease Intervention/treatment Phase
Chronic Shoulder Pain Device: hypertonic dextrose water Device: Normal saline and Lidocaine. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients: Analysis of Clinical and Sonographic Presentation
Study Start Date : June 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: hypertonic dextrose water
20% hypertonic dextrose water injection for chronic shoulder spin
Device: hypertonic dextrose water
20% hypertonic dextrose water injection for chronic shoulder pain at Week0
Other Name: Prolotherapy group

Placebo Comparator: Normal Saline
normal saline and Lidocaine as placebo for sham group
Device: Normal saline and Lidocaine.
Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)
Other Name: Control group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000205


Contacts
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Contact: ShihWei Huang +88622490088 ext 1606 13001@s.tmu.edu.tw

Locations
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Taiwan
Shuang Ho Hospital Recruiting
New taipei city, Zhonghe Dist, Taiwan, 235
Shuang Ho Hospital Recruiting
New taipei city, Zhonghe Dist, Taiwan, 235
Contact: ShihWei Huang    +88622490088 ext 1606    13001@s.tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital

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Responsible Party: Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03000205     History of Changes
Other Study ID Numbers: N201605022
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Taipei Medical University Shuang Ho Hospital:
Dextrose prolotherapy
patients
Additional relevant MeSH terms:
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Shoulder Pain
Tendinopathy
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action