E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sub acute soft tissue injuries to the knee . |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041292 |
E.1.2 | Term | Soft tissue injury NOS |
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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 gain data, as part of a cost benefit analysis prior to purchasing a Hyperbaric Chamber, to evaluate the role of High Dosage Oxygen Therapy (HDOT) as an adjunct to standard physiotherapy in the rehabilitation of soft tissue injuries. |
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E.2.2 | Secondary objectives of the trial |
To estimate the sample size required for a major study (using a Power Calculation) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A sample of police officers (of either gender) referred to the Police Rehabilitation Centre. for a standard 12 day rehabilitation programme for the following conditions: sub acute soft tissue injuries to the knee (i.e. injuries to the knee ligaments, meniscus, or post surgery for knee arthroscopy, ligament repair). For the purposes of the study 'sub acute' will be defined as 3 weeks to 3 months post injury onset or post surgery. The participants must be adults and able to give informed consent. The participants must have no pre existing condition which will exclude them from undertaking Hyperbaric Treatment (they will medically screened prior to the administration of the first treatment and appropriately referred by a qualified medical practitioner).
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E.4 | Principal exclusion criteria |
Chronic Knee Conditions (see definition of sub acute). Ill defined knee conditions (e.g.. internal derrangement of the knee joint (IDKJ) or 'anterior knee pain') Rheumatoid disease Repeated knee injuries Peripheral vascular disease Referred pain from the hip, pelvis or spine. History of pneumothorax Heart condition Trauma to the chest Upper respiraory tract infection Patients who are febrile Pregnancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Measurement of functional ability and validated survey |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Physiotherapy and rehabilitation exercise only |
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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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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The last visit of the last subject undergoing the trial |
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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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |