E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rotator cuff tendinopathy Adhesive capsulitis of the shoulder joint |
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E.1.1.1 | Medical condition in easily understood language |
Painful shoulder caused by entrapment of tendons or 'frozen shoulder' caused by inflammation of the shoulder joint itself. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040617 |
E.1.2 | Term | Shoulder pain |
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 measure feasibility issues including rates of recruitment and loss to follow up, including withdrawal from a randomised trial of a corticosteroid shoulder injection in patients with rotator cuff tendinopathy or adhesive capsulitis. |
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E.2.2 | Secondary objectives of the trial |
To measure response to and satisfaction with the shoulder injection in such patients; to assess the suitability of the participant information materials; to identify any other issues relevant to the design of a larger, definitive efficacy trial. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female, aged 35 to 74 years • Diagnosed with rotator cuff tendinopathy or adhesive capsulitis by a general practitioner trained in shoulder assessment, with duration of symptoms no greater than 6 months • Willing to allow his or her usual General Practitioner to be notified of participation in the study and to be contacted for further information if an adverse event related to the trial occurs • Able to complete follow-up data collection by questionnaire at 2, 4 and 12 weeks • Willing and able to give informed consent for participation in the trial
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E.4 | Principal exclusion criteria |
• Female participants who are pregnant, lactating or planning pregnancy during the course of the study • Participants who have participated in another research study involving an investigational product in the past 12 weeks • Those having already received a shoulder injection in the past 12 months • Those with other established chronic shoulder disorders (e.g. rheumatoid arthritis, other inflammatory poly-arthropathies and osteroarthritis) • A history of previous shoulder surgery on the affected side • Those with evidence of active infection anywhere, including temperature = to or > than 37.5oC • Those currently prescribed anticoagulants • Those either currently prescribed or likely to need during the following 12 months, systemic corticosteroids for any reason • Immunocompromised • Uncontrolled diabetes or uncontrolled hypertension • A diagnosis of heart failure • Those considered unable due to cognitive impairment to reliably report outcome measures • Any other significant disease or disorder which, in the opinion of the general practitioner, may either put the participants at risk because of participation in the study, or may influence the participant's ability to participate in the study. • Any patient who is allergic to corticosteroids and/or lidocaine. |
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E.5 End points |
E.5.1 | Primary end point(s) |
As this is a feasibility study the primary outcome measures will be:
Proportion of screened patients eligible to enter the study Proportion of eligible patients willing to provide consent Rates of recruitment (per practice per week) Loss to follow up including withdrawal Adherence to the allocation treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of study defined as the last follow-up assessment completed by the last patient. |
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E.5.2 | Secondary end point(s) |
The Oxford Shoulder Score at 4 and 12 weeks following the trial injection. Satisfaction questionnaires at 2, 4 and 12 weeks following trial injection.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2, 4 and 12 weeks following the trial 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 |
This is a pilot study to assess the feasibility of conducting a large scale efficacy trial |
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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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | Yes |
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 end of trial is the date of the last follow-up assessment of the last participant |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |