<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03000205</url>
  </required_header>
  <id_info>
    <org_study_id>N201605022</org_study_id>
    <nct_id>NCT03000205</nct_id>
  </id_info>
  <brief_title>Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients</brief_title>
  <official_title>Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients: Analysis of Clinical and Sonographic Presentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University Shuang Ho Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University Shuang Ho Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using hypertonic dextrose water for chronic supraspinatus tendinosis and using ultrasound as&#xD;
      assessment tool to evaluate the effect of intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Supraspinatus tendinosis is a degenerative process of tendon. It can be caused by external&#xD;
      trauma episode and imbalanced of self-repair process. It can cause patients with shoulder&#xD;
      pain when shoulder over head exercise and heavy lifting. It can also influence the sleep&#xD;
      quality due to pain symptoms of shoulder. Usually these patients had limited response to&#xD;
      medication and physical modality. Moreover, it can cause shoulder tear or rupture, which can&#xD;
      disability with aging. Prolotherapy is an injection therapy for chronic painful&#xD;
      musculoskeletal conditions. It involves the injection of small volumes of an irritant agent,&#xD;
      most commonly a hyperosmolar dextrose solution, at multiple painful tendon and ligament&#xD;
      insertions where they connect to bone, over several treatment sessions. The injection of an&#xD;
      irritant solution initiates an inflammatory cascade at the site of injection, which causes&#xD;
      fibroblast proliferation and subsequent collagen synthesis, resulting in a stronger tendon or&#xD;
      ligament. Hyperosmolar dextrose appears to be the most commonly used agent today, with&#xD;
      morrhuate sodium used slightly less often. There is promising recent evidence for&#xD;
      prolotherapy, with hyperosmolar dextrose in treating painful tendinopathies. The aim of this&#xD;
      study is to hypertonic injection in supraspinatus tendinosis patients about clinical and&#xD;
      ultrasound image presentation. We conducted a double blinded randomized controlled trial for&#xD;
      60 participants with chronic shoulder pain for 3 months with supraspinatus tendonsis. In&#xD;
      study group, one injection with 20% dextrose water was injection in supraspinatus tendon and&#xD;
      control group received normal saline and Lidocaine. SPADI, VAS and ultrasound data were&#xD;
      obtained before intervention and 2 weeks, 6 weeks and 12 weeks after injection after&#xD;
      intervention. The ANOVA and independent t test are applied for analysis by SPSS 20.0 with P&#xD;
      value less than 0.05 as statistical significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)</measure>
    <time_frame>Week0 Week2 Week6 Week12</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound</measure>
    <time_frame>Week0 Week2 Week6 Week12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder ROM (Range of Motion)</measure>
    <time_frame>Week0 Week2 Week6 Week12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain (VAS, Visual Analogue Scale)</measure>
    <time_frame>Week0 Week2 Week6 Week12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>hypertonic dextrose water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20% hypertonic dextrose water injection for chronic shoulder spin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal saline and Lidocaine as placebo for sham group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>hypertonic dextrose water</intervention_name>
    <description>20% hypertonic dextrose water injection for chronic shoulder pain at Week0</description>
    <arm_group_label>hypertonic dextrose water</arm_group_label>
    <other_name>Prolotherapy group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Normal saline and Lidocaine.</intervention_name>
    <description>Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)</description>
    <arm_group_label>Normal Saline</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged more than 20 years old with diagnosis of chronic supraspinatus tendinosis by&#xD;
             ultrasound and clinical shoulder pain lasting for more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of shoulder fracture and operation, with frozen shoulder or full thickness&#xD;
             rupture of rotator cuff, steroid, or hyaluronic acid, or platelet rich plasma (PRP)&#xD;
             injection during the period of intervention and following up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shuang Ho Hospital</name>
      <address>
        <city>New taipei city</city>
        <state>Zhonghe Dist</state>
        <zip>235</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dextrose prolotherapy</keyword>
  <keyword>patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Tendinopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000205
org study id: N201605022
nct id: NCT03000205
lead sponsor: 
has dmc: No
Using hypertonic dextrose water for chronic supraspinatus tendinosis and using ultrasound as
      assessment tool to evaluate the effect of intervention.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
time frame: Week0 Week2 Week6 Week12
description: 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.
measure: Ultrasound
time frame: Week0 Week2 Week6 Week12
description: 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.
measure: Shoulder ROM (Range of Motion)
time frame: Week0 Week2 Week6 Week12
description: 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.
measure: Pain (VAS, Visual Analogue Scale)
time frame: Week0 Week2 Week6 Week12
description: 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.
arm group label: hypertonic dextrose water
arm group type: Experimental
description: 20% hypertonic dextrose water injection for chronic shoulder spin
arm group label: Normal Saline
arm group type: Placebo Comparator
description: normal saline and Lidocaine as placebo for sham group
intervention type: Device
intervention name: hypertonic dextrose water
description: 20% hypertonic dextrose water injection for chronic shoulder pain at Week0
arm group label: hypertonic dextrose water
other name: Prolotherapy group
intervention type: Device
intervention name: Normal saline and Lidocaine.
description: Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)
arm group label: Normal Saline
other name: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Tendinopathy
mesh term: Lidocaine
sharing ipd: No