G56.0
Conditions
Interventions
Group 1: The study aims at an investigation of the conservative therapy using a carpal tunnel extension device, the so called Tuttlingen CTS-Cuff (Treatment period: 12 weeks within the study). In cont
Sponsors
Herr Dipl. Ök. Christian Symhoven
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Carpal Tunnel Syndrom diagnosed
Exclusion criteria
Exclusion criteria: The following exclusion criteria were established in order to provide better comparison (also with previous studies). • Treatmend of CTS by Cortison Injection within 6 weeks before entering the study • Multiple compression symptoms or previously surgically treated compression symptoms in the same had or forearm. • Other nerve compression Syndroms than CTS in the same side hand / forearm. • Acute spinal disc Prolaps. Cervical vertebral Syndrom. • Below age of 18. • Paresis or paralysed upper extremities. • Any illness of the central nervous system (CNS). • Previous trauma involving median nerve. • Chronical pain Syndrom (e.g. CRPS etc.). • Problems with the application of the Cuff by the patient. The relevant criteria are assessed and documented in a preliminary questionnaire during first presentation of the patient. In case of a later discovery of an exclusion criterion during the therapy the patient will be excluded from the study in the later stage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement of carpal tunnel symptoms after 3 months (DASH [Disabilities of the Arm, Shoulder and Hand] Score plus clinical indication). This study is limited to a 13 weeks monitoring. The study shall compare effectiveness of the Tuttlinger CTS-Cuff versus surgery after 3 months based on neurological and clinical measurements. The main outcome is the 3 months' change of the distal-motoric latency (DML) reported in msec. A DML decrease is to be expected and there is a one-directional non-inferiority approach. It is expected that the cuff will not be inferior. Any effect by the cuff of at least 75% of the effect by surgery shall be regarded as not inferior. Statistic methods: 152 patients are required in the evaluation to test non-inferiority with a tolerance limit of 0,215 msec. Patient documentation/monitoring: All patients (both groups) are requested to fill in the DASH questionnaire twice: Before the start of the therapy and during the check-up 13 weeks after the start of the therapy. The patients of the Tuttlinger CTS-Cuff document the application of the cuff each day within the first 8 weeks of the therapy, then they report by the week within the next five weeks. All patients (both groups) document in a checklist the subjective sense of pain, numbness / prickling and sleep disorder caused by the CTS pain. The checklist has to be filled in each day within the first 4 weeks, then on a weekly basis within the next 9 weeks. In the control group surgery patients, the process and result of the surgery will be documented after the surgery. Patients shall hand in their reports on a weekly basis. Filling in the DASH questionnaire is mandatory at the start and at the end of the study. Data management, statistical analysis and quality control: Data management and analysis will be performed by Klinikum Tuttlingen. All statistical evaluations will be done in parallel by CMC Medical AG and the results will be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of carpal tunnel symptoms based on neurological measurement after 3 months. | — |
Countries
Germany
Contacts
Public ContactCaterina Poma-Schmidt
Gesundheitszentrum Spaichingen im Klinikum Landkreis Tuttlingen
Outcome results
None listed