E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Carpal Tunnel Syndrome (CTS) |
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E.1.1.1 | Medical condition in easily understood language |
Condition in which the nerve is squeezed where it passes through the wrist, causing pain, aching, tingling or numbness in the affected hand. |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007697 |
E.1.2 | Term | Carpal tunnel syndrome |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007697 |
E.1.2 | Term | Carpal tunnel syndrome |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052414 |
E.1.2 | Term | Unilateral carpal tunnel syndrome |
E.1.2 | System Organ Class | 10029205 - Nervous system 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 |
The primary objective of this trial is to investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term (6 weeks) compared to a night splint in people consulting with mild to moderate carpal tunnel syndrome in primary care.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this trial are: •To investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the medium term (6 months) compared to a night splint in people consulting with mild to moderate carpal tunnel syndrome in primary care. •To investigate whether a steroid injection is cost-effective compared with a night splint in people consulting with mild to moderate carpal tunnel syndrome in primary care, and whether it leads to a reduction in health care resource use or work absence over 6 months. •Subject to further funding, participants will be followed-up over the longer term for 24 months to examine differences across the whole 24 month follow-up period in: o health care resource use or work absence o patterns in specific clinical outcomes (Boston CTS questionnaire and pain intensity NRS) o referral for CTS surgery
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Factors, both medical and non-medical, will be taken into account including whether a patient will be able to participate in the trial. 1.Male or female aged ≥ 18 years 2.A clinical diagnosis of unilateral or bi-lateral CTS as made by a GP or trained clinician according to the diagnostic criteria 3.Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature 4.Symptom duration of episode of at least 6 weeks 5.Written informed consent provided by the patient, prior to any trial specific procedures
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E.4 | Principal exclusion criteria |
Participants with the following characteristics are ineligible for the trial: 1.Steroid injection or night splints for CTS in the affected wrist within preceding 6 months 2.Any previous surgery on the affected wrist 3.Severe CTS exhibiting constant numbness or pain, constant sensory loss, severe thenar muscle atrophy or symptom severity which requires the patient to be referred for a surgical opinion 4.Clinical suspicion of local or systemic sepsis or infection 5.Current or previous infection of the affected wrist 6.Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months 7.Unable to tolerate the study interventions 8.Unable to understand and complete self-report questionnaires written in English 9.Inter-current illness including, but not limited to: •poorly controlled thyroid disease •poorly controlled diabetes mellitus •vibration-induced neuropathy •inflammatory joint disease •suspected complex neurological conditions •any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation 10.Pregnant or lactating females 11.Receiving anticoagulants 12.Any history of hypersensitivity to Depo-Medrone or any of its excipients (refer to the Summary of Product Characteristics (SPC)) 13.Allergy to any of the splint materials 14.Known abuse of drugs or alcohol 15.Involved in on-going litigation cases for their condition
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure for the study is symptom severity and limitations in hand function as assessed by the Boston CTS questionnaire. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint is at 6 weeks post-randomisation.
The primary outcome measure will also be assessed at 6 weeks, 6-, 12-, and 24-months post randomisation. |
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E.5.2 | Secondary end point(s) |
Secondary outcome measures are as follows: •Hand-wrist symptom intensity (0-10 numerical rating scale) •Interrupted sleep •Adherence to splinting where indicated •Patients’ perceived benefit and satisfaction with treatment •Impact of CTS on work and other activities (including work absence and reduction in performance measured by a 0-10 rating scale for work performance) •Referral for surgery •General health (EQ-5D-5L) •Health care utilisation and patient incurred costs •Use of co-interventions such as supplements, pain relief, etc
Participants’ expectations regarding treatment response will be explored as potential effect modifiers. Adherence to treatment will be captured in the participant questionnaires (in particular use of the splint).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary outcome measures will assess outcomes at 6 weeks, 6-, 12-, and 24-months post randomisation. |
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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 | 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 | Yes |
E.8.1.3 | Single blind | No |
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
| 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 | 50 |
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 the collection of the last data item for the last participant to be randomised. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |