Carpal tunnel syndrome Nervous System Diseases Carpal tunnel syndrome
Conditions
Interventions
Patients will be randomized using a centralized web-based application. Eligible patients will be randomized in a 1:1 ratio to the initial steroid injection or the initial surgical intervention.
The i
Sponsors
Academisch Medisch Centrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years or older at time of examination 2. Clinically suspected CTS 3. Symptoms being present for at least 6 weeks 4. Electrophysiological or sonographic confirmed CTS according to the Dutch carpal tunnel syndrome guideline 5. Treatment within 6 weeks after inclusion Added 06/04/2018: 6. The patient can only be included for the treatment of one hand if both hands are eligible 7. Surgery and injection are both considered as potential treatments for the CTS related symptoms
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/04/2018: 1. Follow-up not possible 2. A previous history of surgery for CTS on the ipsilateral wrist 3. An injection for CTS in the ipsilateral wrist less than one year ago 4. Previously participating in the DISTRICTS 5. Clinical or neurophysiological suggestion of another diagnosis, like: 5.1. Cervical radiculopathy 5.2. Cervical myelopathy 5.3. Brachial plexopathy including thoracic outlet syndrome 5.4. Mononeuropathies, such as pronator teres syndrome 5.5. Polyneuropathy, including Hereditary Neuropathy with Liability to Pressure Palsies 5.6. Complex regional pain syndrome 6. Unable to comprehend Dutch self-report questionnaires 7. Legally incompetent adults 8. Pregnancy 9. No informed consent Previous exclusion criteria: 1. Follow-up not possible 2. History of wrist fracture/trauma/operation 3. A previous history of injection or surgery for CTS 4. Previously participating in the DISTRICTS 5. Clinical or neurophysiological suggestion of another diagnosis that can influence CTS, like: 5.1. Cervical radiculopathy 5.2. Cervical myelopathy 5.3. Brachial plexopathy including thoracic outlet syndrome 5.4. Mononeuropathies, such as pronator teres syndrome 5.5. Polyneuropathy, including hereditary neuropathy with liability to pressure palsies 5.6. Complex regional pain syndrome 6. Secondary CTS due to known underlying cause including, but not limited to: 6.1. Thyroid disease 6.2. Rheumatoid arthritis 6.3. Diabetes mellitus 6.4. Dialysis due to kidney failure 6.5. Space-occupying lesion at the volar side of the wrist 6.6. Pregnancy 7. Known allergy to corticosteroids 8. Unable to comprehend Dutch self-report questionnaires 9. Legally incompetent adults 10. No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 26/09/2017: Number of patients recovered, defined as having no or mild CTS symptoms as measured with the 6-item carpal tunnel symptoms scale (CTS-6), at 18 months Previous primary outcome measures: 1. Number of patients recovered, defined as having no or mild CTS symptoms as measured with the 6-item carpal tunnel symptoms scale (CTS-6), at 18 months 2. Time to recovery, defined as the first timepoint after the last intervention (e.g., splitting, steroid injection or surgical treatment) scoring less than 8 points if this timepoint is followed by a consecutive timepoint with a favorable outcome and no additional treatments afterwards, or if this is the last timepoint at 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to recovery, defined as the first timepoint after the last intervention (e.g., splitting, steroid injection or surgical treatment) scoring less than 8 points if this timepoint is followed by a consecutive timepoint with a favorable outcome and no additional treatments afterwards, or if this is the last timepoint at 18 months (moved from primary outcome measures to secondary outcome measures on 26/09/2017) 2. Number of patients recovered, defined as having no or mild CTS symptoms as measured with the 6-item carpal tunnel symptoms scale (CTS-6), at 6 weeks and 3, 6, 9, 12, and 15 months 3. Level of symptom severity, measured using the CTS-6 questionnaire at 6 weeks and 3, 6, 9,12, 15, and 18 months 4. Hand functioning, measured using the QuickDASH at 18 months follow-up 5. Scar or palm pain, measured using the palmar pain scale at 6 weeks, 3, 6, 9, 12, 15 and 18 months (added 09/04/2018) 5. Patient’s global perception of recovery, measured with a 7-point Likert-type item ranging from 1 (substantially deteriorated) to 7 (substantially recovered) at baseline and 18 months 6. Patient satisfaction, measured with a 7 point Likert-type item ranging from 1 (very dissatisfied) to 7 (very satisfied) at 18 months 7. Quality of life, assessed with the EuroQol (EQ-5D-5L) at 18 months 8. Number of additional treatments, defined as every treatment initiated by the neurologist after initial treatment, such as but not limited to steroid injections, (re)surgery, braces. Additional undergone treatments are determined at 6 weeks and 3, 6, 9, 12, 15, and 18 months 9. Number of adverse events, defined as the frequency, severity, nature, and duration of any adverse event throughout the course of the study. Adverse events are determined at 6 weeks and 3, 6, 9,12,15, and 18 months 10. Use of care and health-related costs during follow-up, assessed with the adapted Medical Consumption Questionnaire and the Productivity Cost Questionnaire at 3, 6, 12 and 18 months | — |
Countries
Netherlands
Outcome results
None listed