E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Trigger finger De Quervains tenosynovitis Carpal tunnel syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Trigger finger is a condition in which your finger or thumb ’catches’ or gets locked in place when you bend it. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10044654 |
E.1.2 | Term | Trigger finger |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether pain experienced at 1-hour after a corticosteroid injection to the hand and wrist is no worse than (not inferior to) the pain experienced after a corticosteroid and local anaesthetic injection. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives; i) Investigate whether there is a difference in pain VAS scores during the 24-hours after a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic.
ii) Investigate whether there is a difference in the pain VAS scores at the time of the corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic.
iii) Investigate the difference in the additional analgesia required and in the functional use of the hand during the first 3 hours following a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female ages >/= 18 years.
A clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome made by a consultant physician.
Treatment with corticosteroid injection is recommended by the doctor and agreed by the patient.
Patient is willing and able to give informed consent for participation in the study. |
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E.4 | Principal exclusion criteria |
Previous surgery for the condition being treated at the desired location of injection (Previous corticosteroid injection elsewhere in the hand or wrist does not exclude the patient from the trial).
Previous steroid injection for the condition being treated at the desired location of injection (Previous surgery elsewhere in the hand or wrist does not exclude the patient from the trial).
Clinical suspicion of local or systematic sepsis or infection.
History of hypersensitivity to the corticosteroid or local anaesthetic.
Pregnant or breast-feeding females.
Unable to understand and complete self-report questionnaires written in English. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Investigate whether there is a difference in pain VAS scores at 1-hour after a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Investigate whether there is a difference in pain after 24 hours.
Investigate a difference in pain VAS scores at the time of injection with and without local anaesthetic.
Investigate the difference in additional analgesia required in the functional use of the hands in the first three hours following injection with or without local anaesthetic. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before injection, 5 minutes after, 1 hour, 2 hours, 3 hours, 24 hours post injection. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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When the 100th recruited participant has returned their patient assessment record |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |