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    Clinical Trial Results:
    Botox injektion in the hip joint for pain relief and diagnosis of pain lokalisation.

    Summary
    EudraCT number
    		 2019-004488-33
    Trial protocol
    		 DK  
    Global end of trial date
    31 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Dec 2025
    First version publication date
    20 Dec 2025
    Other versions
    Summary report(s)
    		 Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    Prada2500?
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Deparment of radiology, HE midt
    Sponsor organisation address
    Falkevej 1, 8600 Silkeborg, Silkeborg, Denmark, 8600
    Public contact
    Røntgen og skanning , Silkeborg Regionshospital, +45 78417500, nb@dadlnet.dk
    Scientific contact
    Røntgen og skanning , Silkeborg Regionshospital, 24798452 78417500, nb@dadlnet.dk
    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
    31 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Pain measured on VAS score scale 1,2 and 6 weeks after intraarticular injection of Botox in the painfull hipjoint. Change of Hagos and iHOT 12 score 6 from day 0 to 6 weeks after intraarticular injection of Botox in the painfull hipjoint.
    Protection of trial subjects
    Anonymisation of results in all possible ways and Redcap access restricted to all but myself leader of the project. Medicine embalage and papers generated during the study will be stored under lock for 5 years.
    Background therapy
    		 Patients received no background therapy but only received one injection with study medicine.
    Evidence for comparator
    		 No comparators were used in the trial.
    Actual start date of recruitment
    01 Mar 2020
    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
    Denmark: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with hip pain 6 month after periacetabular osteotomy were included between 12.11.2020 and 31.05.2024. Patients were recuted in the follow up ambulatory In Ortopædic department Aarhus university hospital and Regional hospital Horsens. Medicine was given at Regional hospital Silkeborg at the Radiology department.

    Pre-assignment
    Screening details
    		 Consecutive patients with hip pain 6 month after periacetabular osteotomy were included between 12.11.2020 and 31.05.2024. Patients were recuted in the follow up ambulatory In Ortopædic department Aarhus university hospital and Regional hospital Horsens. Patients fulfilling inclusion criteria were offered enrolement.

    Period 1
    Period 1 title
    Baseline period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open study - with no blinding as it was a preliminary study.

    Arms
    Arm title
    		 Botox
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    we used 100 IU of Botox type A toxin from Allergan, dissolved in 3 ml of Sodium Chloride 9 mg/ml from Fresenius Kabi and mixed with 3 ml of Xylocaine (Lidocaine) 10 mg/ml from Astra Zeneca.

    Number of subjects in period 1
    		Botox
    Started
    11
    Completed
    10
    Not completed
    1
         Consent withdrawn by subject
    1
    Period 2
    Period 2 title
    followup week 6
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Botox
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    we used 100 IU of Botox type A toxin from Allergan, dissolved in 3 ml of Sodium Chloride 9 mg/ml from Fresenius Kabi and mixed with 3 ml of Xylocaine (Lidocaine) 10 mg/ml from Astra Zeneca.

    Number of subjects in period 2
    		Botox
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline period
    Reporting group description
    		 -

    Reporting group values
    		 Baseline period Total
    Number of subjects
    		 11 11
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Adults
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Botox
    Reporting group description
    		 -
    Reporting group title
    Botox
    Reporting group description
    		 -

    Primary: Pain relief

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    End point title
    		 Pain relief
    End point description
    End point type
    Primary
    End point timeframe
    baseline and 6 week followup
    End point values
    		 Botox Botox
    Number of subjects analysed
    10
    10
    Units: VAS point scale
        number (not applicable)
    10
    10
    Statistical analysis title
    		 Pain relief, HAGOS and iHOT12
    Comparison groups
    Botox v Botox
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Patients were followed 6 weeks after injection og study medicine.
    Adverse event reporting additional description
    Patients were seen after 6 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Frequency threshold for reporting non-serious adverse events: 0%
    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 non-serious event was reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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