Steroid Injection Treatment of Carpal Tunnel Syndrome

Region Skane

Status and phase: Completed; Phase 3; Phase 2

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Methylprednisolone 80 mg; Drug: Sodium chloride; Drug: Methylprednisolone 40 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00806871

prövningsprotokoll 080723

Details and patient eligibility

About

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.

Full description

www.biomedcentral.com/1471-2474/11/76

Enrollment: 112 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: Methylprednisolone 40 mg

B

Active Comparator group

Treatment:

Drug: Methylprednisolone 80 mg

C

Placebo Comparator group

Treatment:

Drug: Sodium chloride