Steroid Injection Treatment of Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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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
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www.biomedcentral.com/1471-2474/11/76

Official Title
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Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Methylprednisolone 40 mg
* Drug: Methylprednisolone 80 mg
* Drug: Sodium chloride


Participation Criteria
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Eligibility Criteria
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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)exclusion criteria Exclusion Criteria: Previous steroid injection for CTS in the same wrist Inflammatory joint disease, diabetes mellitus· Vibration-induced neuropathy, polyneuropathy Pregnancy Trauma to the affected hand in the previous year Previous CTS surgery in the affected hand Inability to complete questionnaires due to language problem or cognitive disorder Severe medical illness Known abuse of drugs and/or alcohol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Methylprednisolone 40 mg<br>* 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<br>* Other names: Depo-medrol;|
| Active Comparator: B<br> | Drug: Methylprednisolone 80 mg<br>* Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use. 2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine<br>* Other names: Depo-medrol;|
| Placebo Comparator: C<br> | Drug: Sodium chloride<br>* Saline solution 0,9%, injection in the carpal tunnel, one time use 1 ml 10 mg Lidocaine + 2 ml saline<br>* Other names: NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The CTS symptom severity score after treatment. |  | 10 weeks | 
| Rate of surgery |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The CTS symptom severity score after treatment |  | 52 weeks | 
| Time to surgery |  | 52 weeks | 
| QuickDASH score |  | 52 weeks | 
| SF-6D score |  | 52 weeks | 
| Patient satisfaction with the results of treatment (VAS scale) |  | 52 weeks | 
| Registration of adverse events |  | 24 weeks |