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    Clinical Trial Results:
    The value of a High-Volume Image-Guided Injections (HVIGI) in chronic midportion Achilles tendinopathy: a double-blind, placebo-controlled, randomised clinical trial

    Summary
    EudraCT number
    		 2015-000180-13
    Trial protocol
    		 NL  
    Global end of trial date
    16 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Dec 2021
    First version publication date
    05 Dec 2021
    Other versions
    Summary report(s)
    		 Publication article BMJ

    Trial information

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    Trial identification
    Sponsor protocol code
    HAT1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02996409
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nederlands Trialregister (NTR): TC = 4916
    Sponsors
    Sponsor organisation name
    Erasmus University Medical Center
    Sponsor organisation address
    Dr. Molewaterplein 40, Rotterdam, Netherlands, 3015 GD
    Public contact
    Afdeling Sportgeneeskunde, Haaglanden Medisch Centrum, 0031 70357 42 35,
    Scientific contact
    Afdeling Sportgeneeskunde, Haaglanden Medisch Centrum, 0031 70357 42 35,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the value of High-Volume Image-Guided Injections in patiënts with chronic midportion Achilles tendinopathy.
    Protection of trial subjects
    Via ethical committee
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In detail described in publication

    Pre-assignment
    Screening details
    		 In detail described in publication

    Period 1
    Period 1 title
    December 2016 to January 2019 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 high volume injection without corticosteroids
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saline +lidocain 40 cc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Described in detail in publication

    Arm title
    		 low-volume saline injection
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline +lidocain 2 cc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Described in detail in publication

    Number of subjects in period 1
    		high volume injection without corticosteroids low-volume saline injection
    Started
    39
    41
    Completed
    38
    41
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    high volume injection without corticosteroids
    Reporting group description
    		 -

    Reporting group title
    low-volume saline injection
    Reporting group description
    		 -

    Reporting group values
    		 high volume injection without corticosteroids low-volume saline injection Total
    Number of subjects
    		 39 41 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 39 41 80
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        least squares mean (standard deviation)
    		 46.9 ( 8.1 ) 48.9 ( 9.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 19 41
        Male
    		 17 22 39

    End points

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    End points reporting groups
    Reporting group title
    high volume injection without corticosteroids
    Reporting group description
    		 -

    Reporting group title
    low-volume saline injection
    Reporting group description
    		 -

    Primary: VISA-A score

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    End point title
    		 VISA-A score
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 high volume injection without corticosteroids low-volume saline injection
    Number of subjects analysed
    38
    41
    Units: score 0-100
    38
    41
    Statistical analysis title
    		 SAP
    Statistical analysis description
    Described in detail in the publication and the protocol of the study
    Comparison groups
    low-volume saline injection v high volume injection without corticosteroids
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 GEE
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During entire study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 regular follow-up
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2016
    Described in detail in the publication

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Jan 2016
    Described in detail in the publication
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Described in detail in the publication

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33315586
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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