E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rotator Cuff Partial Tear (not full tear) |
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E.1.1.1 | Medical condition in easily understood language |
Severe Shoulder Pain that stops shoulder movement |
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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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039226 |
E.1.2 | Term | Rotator cuff injury |
E.1.2 | System Organ Class | 100000004859 |
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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 |
The primary research objective is to assess whether:
An individually tailored progressive exercise programme, that includes behavioural change strategies, led by a physiotherapist provides greater improvement in shoulder pain and function at 12 months post-randomisation than a best practice advice session with a physiotherapist supported by high quality materials; and whether an injection into the shoulder (a subacromial corticosteroid injection) provides greater improvement in shoulder pain and function at 12 months post-randomisation than no injection.
This will be assessed by the the pain and function levels of each participant at 12 months after entering the trial. |
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E.2.2 | Secondary objectives of the trial |
Do participants in the different treatment groups have differences in: Pain, Function, Quality of Life, Sleep disturbance, Medication usage, usage of the NHS, Time off work, their undertaking of the treatment and their feelings towards their treatment at 8 weeks, 6 and 12 months after entering the trial.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Men and women aged 18 years and above; 2) with a new episode of shoulder pain (i.e., within the last 6 months) attributable to a rotator cuff disorder (e.g., cuff tendonitis, impingement syndrome, tendinopathy or rotator cuff tear) using the diagnostic criteria set out in the BESS (British Shoulder and Elbow Society) guidelines; 3) who are not currently receiving physiotherapy; 4) who are not being considered for surgery; and 5) able to understand spoken and written English. |
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E.4 | Principal exclusion criteria |
1) Participants with a history of significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery); 2) those with a neurological disease affecting the shoulder; 3) those with other shoulder disorders (e.g., inflammatory arthritis, frozen shoulder, glenohumeral joint instability) or with red flags consistent with the criteria set out in the BESS guidelines; 4) those who have received corticosteroid injection or physiotherapy for shoulder pain in the last 6 months; and 5) those with contra-indications to corticosteroid injection. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is shoulder pain and function at 12 months measured using the well-validated Shoulder Pain and Disability Index (SPADI), which was developed to measure current shoulder pain and disability in an outpatient setting. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 months after randomisation |
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E.5.2 | Secondary end point(s) |
Do participants in the different treatment groups have differences in: Pain, Function, Quality of Life, Sleep disturbance, Medication usage, usage of the NHS, Time off work, their undertaking of the treatment and their feelings towards their treatment at 8 weeks, 6 and 12 months after entering the trial.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
8 weeks, 6 months and 12 months |
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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 | Yes |
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 | No |
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 | Yes |
E.8.1.3 | Single blind | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 |
2 x 2 factorial - no comparator per se - all arms will be |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 10 |
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 the trial is defined as when all data has been received and all queries resolved. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 2 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 1 |