Steroid Injection Treatment of Carpal Tunnel Syndrome

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

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.

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

Intervention(s) in this Clinical Trial

• Drug: Methylprednisolone 40 mg
  • 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
• Drug: Methylprednisolone 80 mg
  • Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use. 2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine
• Drug: Sodium chloride
  • Saline solution 0,9%, injection in the carpal tunnel, one time use 1 ml 10 mg Lidocaine + 2 ml saline

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B
• Placebo Comparator: C

Primary Measures

• The CTS symptom severity score after treatment.
  • Time Frame: 10 weeks
    Safety Issue?: No
• Rate of surgery
  • Time Frame: 52 weeks
    Safety Issue?: No

Secondary Measures

• The CTS symptom severity score after treatment
  • Time Frame: 52 weeks
    Safety Issue?: No
• Time to surgery
  • Time Frame: 52 weeks
    Safety Issue?: No
• QuickDASH score
  • Time Frame: 52 weeks
    Safety Issue?: No
• SF-6D score
  • Time Frame: 52 weeks
    Safety Issue?: No
• Patient satisfaction with the results of treatment (VAS scale)
  • Time Frame: 52 weeks
    Safety Issue?: No
• Registration of adverse events
  • Time Frame: 24 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Region Skane Other

Overall Clinical Trial Officials and Contacts

Isam Atroshi, MD, PhD Study Chair Lund university, department of clinical sciences, Hässleholm hospital, department of orthopedics  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00806871

Study ID Number: prövningsprotokoll 080723

ClinicalTrials.gov Identifier: NCT00806871

Health Authority: Sweden: Medical Products Agency