Carpal tunnel syndrome - median neuropathy caused by nerve entrapment at the site of the carpal tunnel in the wrist MedDRA version: 20.0 Level: PT Classification code 10007697 Term: Carpal tunnel syndrome System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: LLT Classification code 10007696 Term: Carpal tunnel release System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10007695 Term: Carpal tunnel dec
Conditions
Interventions
Trade Name: Lederspan
Pharmaceutical Form: Injection
INN or Proposed INN: TRIAMCINOLONE HEXACETONIDE
CAS Number: 5611-51-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C
Sponsors
Diakonhjemmet sykehus
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: - 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 ;Primary end point(s): Successful treatment result, defined as Boston Carpal Tunnel Questionnaire Symtom Severity Scale (BCTQ SSS) score = 1.5;Timepoint(s) of evaluation of this end point: After 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: At various timepoints, see E.5.2 | — |
Countries
Norway
Contacts
Public ContactDiakonhjemmet sykehus
Diakonhjemmet sykehus
Outcome results
None listed