E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Carpal tunnel syndrome - median neuropathy caused by nerve entrapment at the site of the carpal tunnel in the wrist |
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E.1.1.1 | Medical condition in easily understood language |
Carpal tunnel syndrome, caused by compression of the median nerve in the wrist, causing numbness, tingling or discomfort in the hand and/or fingers |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007696 |
E.1.2 | Term | Carpal tunnel release |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 | 10007695 |
E.1.2 | Term | Carpal tunnel decompression |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Assess if the success-rate of a treatment strategy for carpal tunnel syndrome with initial ultrasound-guided injection therapy with up to two injections, scheduled clinical assessment of treatment effect, and subsequent surgery if needed, is non-inferior to a treatment strategy where surgery is the primary treatment, evaluated 12 months after the first intervention |
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E.2.2 | Secondary objectives of the trial |
- Estimate if the success-rate of the injection strategy is non-inferior to primary surgery in a shorter or longer perspective - Estimate success rate of one and two steroid injections - Assess the proportion of patients with need for secondary surgery in the injection arm - To evaluate cost effectiveness and health economic impact of the treatment strategies - To compare the safety of the two study-arms - To assess predictors of patient outcomes
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult (≥18 years of age) • Patient history indicating carpal tunnel syndrome • Neurophysiological examination performed within 6 months • Diagnosis of carpal tunnel syndrome based on: o Classic/probable or possible symptoms, and neurophysiological findings consistent with carpal tunnel syndrome Or, in case of normal neurophysiological findings: o Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms • Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)
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E.4 | Principal exclusion criteria |
Prior/concomitant therapy • Previous carpal tunnel syndrome surgery or corticosteroid injection in the carpal tunnel in the relevant hand Medical conditions • Diagnosis of severe carpal tunnel syndrome, based on history and examination indicating severe carpal tunnel syndrome with constant symptoms including pain, loss of sensibility, dexterity or reduced temperature sensation, weakness of thumb abduction and opposition, or atrophy of thenar musculature. Disappearance of pain may indicate permanent sensory loss. • History suggesting underlying causes of carpal tunnel syndrome e.g. inflammatory wrist arthritis and/or flexor tenosynovitis • Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand • Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury • Major co-morbidities, such as severe malignancies, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV) and/or severe respiratory diseases, leukopenia and/or thrombocytopenia • Severe psychiatric or mental disorders • Pregnancy (for most women pregnancy-related carpal tunnel syndrome will regress after delivery, and therefore surgery is seldom indicated • Any other medical condition that according to the treated physician and/or local guidelines makes adherence to treatment protocol impossible Other exclusion criteria • Alcohol or other substance abuse • Language barriers • Other factors which make adherence to study protocol impossible |
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E.5 End points |
E.5.1 | Primary end point(s) |
Successful treatment result, defined as Boston Carpal Tunnel Questionnaire Symtom Severity Scale (BCTQ SSS) score ≤ 1.5 |
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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) |
- Successful treatment result after 3, 6 and 24 months - Successful treatment result after one injection, and after two injections - Proportion of patients in the injection arm who have undergone surgery after 2 weeks, 3, 6, 12 and 24 months - Work performance/participation and health care utilization at each, or a combination, of time points. - Adverse events throughout the study - Patient-reported measures of symptoms and function, ultrasound and NCS measures at each time point |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At various timepoints, see E.5.2 |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 |
Cost effectiveness and health economic impact |
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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 | Yes |
E.8.1.7.1 | Other trial design description |
Investigator-initiated, prospective, non-inferiority comparative |
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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 |
Ultrasound guided corticosteroid injection compared to surgery |
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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 | 2 |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |