Carpal Tunnel Syndrome
Conditions
Brief summary
The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured with patient evaluated symptoms score.Out of the patients referred by primary care, those with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is judged by the examining surgeon to warrant surgery are offered to be put on the waiting list for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who give informed consent will be asked to attend the outpatient clinic for a physical examination followed by allocation to one of the three trial groups. Immediately following the allocation the patients will receive the assigned treatment.
Detailed description
www.biomedcentral.com/1471-2474/11/76
Interventions
Depo-medrol 40 mg , suspension, injection in the carpal tunnel, one time use 1 ml 40 mg Methylprednisolone + 1 ml 10mg Lidocaine + 1 ml saline
Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use. 2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine
DRUGSodium chloride
Saline solution 0,9%, injection in the carpal tunnel, one time use 1 ml 10 mg Lidocaine + 2 ml saline
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Primary, idiopathic CTS * Age 18-70 years, either gender * Symptom duration of at least 3 months and inadequate response to wrist splint * Symptoms of classic or probable CTS according to the diagnostic criteria in Katz hand diagram * Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the absence of abnormal nerve conduction study results, 2 surgeons should independently diagnose the patient with CTS. * Scheduled for carpal tunnel release (ie, symptom severity indicating need for surgery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The CTS symptom severity score after treatment. | 10 weeks |
| Rate of surgery | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| QuickDASH score | 52 weeks |
| SF-6D score | 52 weeks |
| The CTS symptom severity score after treatment | 52 weeks |
| Registration of adverse events | 24 weeks |
| Patient satisfaction with the results of treatment (VAS scale) | 52 weeks |
| Time to surgery | 52 weeks |
Countries
Sweden
Outcome results
None listed