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
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EudraCT number |
2015-000180-13 |
Trial protocol |
NL |
Global end of trial date |
16 Jul 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Dec 2021
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First version publication date |
05 Dec 2021
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Other versions |
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Summary report(s) |
Publication article BMJ |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
HAT1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02996409 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Nederlands Trialregister (NTR): TC = 4916 | ||
Sponsors
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Sponsor organisation name |
Erasmus University Medical Center
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Sponsor organisation address |
Dr. Molewaterplein 40, Rotterdam, Netherlands, 3015 GD
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Public contact |
Afdeling Sportgeneeskunde, Haaglanden Medisch Centrum, 0031 70357 42 35,
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Scientific contact |
Afdeling Sportgeneeskunde, Haaglanden Medisch Centrum, 0031 70357 42 35,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Jul 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Jul 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jul 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate the value of High-Volume Image-Guided Injections in patiënts with chronic midportion Achilles tendinopathy.
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Protection of trial subjects |
Via ethical committee
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 80
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Worldwide total number of subjects |
80
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EEA total number of subjects |
80
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
80
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
In detail described in publication | |||||||||||||||
Pre-assignment
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Screening details |
In detail described in publication | |||||||||||||||
Period 1
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Period 1 title |
December 2016 to January 2019 (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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high volume injection without corticosteroids | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Saline +lidocain 40 cc
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
Described in detail in publication
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Arm title
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low-volume saline injection | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Saline +lidocain 2 cc
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
Described in detail in publication
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Baseline characteristics reporting groups
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Reporting group title |
high volume injection without corticosteroids
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
low-volume saline injection
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
high volume injection without corticosteroids
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Reporting group description |
- | ||
Reporting group title |
low-volume saline injection
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Reporting group description |
- |
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End point title |
VISA-A score | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24 weeks
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Statistical analysis title |
SAP | |||||||||
Statistical analysis description |
Described in detail in the publication and the protocol of the study
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Comparison groups |
low-volume saline injection v high volume injection without corticosteroids
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
GEE | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
During entire study
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
regular follow-up | ||
Dictionary version |
1
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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 |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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08 Feb 2016 |
Described in detail in the publication |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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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 |
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http://www.ncbi.nlm.nih.gov/pubmed/33315586 |