Steroid Injection Treatment of Carpal Tunnel Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT00806871
First received: December 10, 2008
Last updated: April 3, 2012
Last verified: March 2011

December 10, 2008
April 3, 2012
November 2008
April 2012   (final data collection date for primary outcome measure)
  • The CTS symptom severity score after treatment. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Rate of surgery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806871 on ClinicalTrials.gov Archive Site
  • The CTS symptom severity score after treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to surgery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • QuickDASH score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • SF-6D score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction with the results of treatment (VAS scale) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Registration of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Steroid Injection Treatment of Carpal Tunnel Syndrome
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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
  • 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

    Other Name: Depo-medrol
  • 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

    Other Name: Depo-medrol
  • Drug: Sodium chloride

    Saline solution 0,9%, injection in the carpal tunnel, one time use

    1 ml 10 mg Lidocaine + 2 ml saline

    Other Names:
    • Saline
    • NaCl
  • Active Comparator: A
    Intervention: Drug: Methylprednisolone 40 mg
  • Active Comparator: B
    Intervention: Drug: Methylprednisolone 80 mg
  • Placebo Comparator: C
    Intervention: Drug: Sodium chloride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00806871
prövningsprotokoll 080723
Yes
Region Skane
Region Skane
Not Provided
Study Chair: Isam Atroshi, MD, PhD Lund university, department of clinical sciences, Hässleholm hospital, department of orthopedics
Region Skane
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP