Carpal tunnel syndrome Nervous System Diseases Carpal tunnel syndrome
Conditions
Interventions
Current intervention as of 28/04/2021:
A total of 112 eligible patients who accept participation and provide informed consent will be randomized according to a computer-generated list to treatment wit
Sponsors
Region Skåne
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/06/2018: 1. Primary, idiopathic carpal tunnel syndrome (CTS) 2. Age 25-65 years, either sex 3. Symptoms of classic or probable CTS according to the criteria in Katz hand diagram 4. Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the presence of normal nerve conduction study results, two orthopedic or hand surgeons independently diagnose the patient as having CTS 5. Symptom duration of at least 1 month Previous inclusion criteria: 1. Primary, idiopathic carpal tunnel syndrome (CTS) 2. Age 25-65 years, either sex 3. Symptoms of classic or probable CTS according to the criteria in Katz hand diagram 4. Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the presence of normal nerve conduction study results, two orthopedic or hand surgeons independently diagnose the patient as having CTS 5. Symptom duration of at least 1 month 6. Symptom severity score at least 1.8 on the 6-item CTS symptoms scale (CTS-6)
Exclusion criteria
Exclusion criteria: 1. CTS classified as severe (thenar atrophy or 2-point discrimination exceeding 8 mm in at least 1 finger) 2. Treatment of the study hand with a wrist splint in the past year 3. Previous steroid injection for CTS in the study hand 4. Inflammatory joint disease 5. Vibration-induced neuropathy 6. Polyneuropathy 7. Current pregnancy 8. Trauma to the study hand in the past year 9. Previous CTS surgery in the study hand 10. Inability to complete questionnaires due to language difficulties or cognitive disorder 11. Severe medical illness 12. Known abuse of drugs and/or alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 13/11/2025: 1. Change in the 6-item CTS symptom score from baseline to 12 weeks 2. Rate of carpal tunnel release surgery at 52 weeks _____ Previous primary outcome(s): 1. Change in CTS symptoms, measured with the 6-item CTS symptoms scale at baseline, 6 weeks and 12 weeks 2. Rate of surgery at 52 weeks, measured in percent (proportion of patients that had surgery within 52 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 13/11/2025: 1. Change in the 6-item CTS symptoms score from baseline to 6 weeks and 52 weeks 2. Change in QuickDASH score from baseline to 12 weeks and 52 weeks 3. Change in patient satisfaction score at 12 weeks and 52 weeks 4. Change in EQ-5D index from baseline to 12 weeks and 52 weeks 5. Cost-effectiveness at 52 weeks 6. Palmar pain score at 52 weeks 7. Time to surgery within 52 weeks 8. Duration of sick leave during 52 weeks 9. Change in grip strength from baseline to 52 weeks 10. Adverse events at 52 weeks _____ Previous key secondary outcome(s): 1. TS symptoms, measured with the 6-item CTS symptoms scale score at 52 weeks 2. Activity limitations, measured with the 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale score at baseline, 12 weeks and 52 weeks 3. Health status and quality of life, measured with the EQ-5D index at baseline, 12 weeks and 52 weeks 4. Grip strength, measured with the Jamar dynamometer at baseline and 52 weeks 5. Patient satisfaction, measured with the visual analogue scale (VAS) at 12 weeks and 52 weeks 6. Palmar pain, measured with the 2-item palmar pain scale at 52 weeks 7. Time to surgery, measured in weeks, within 52 weeks 8. Duration of sick leave, measured in days/weeks/months during 52 weeks 9. Adverse events | — |
Countries
Sweden
Outcome results
None listed