Steroid Injection Treatment of Carpal Tunnel Syndrome

April 3, 2012 updated by: Region Skane

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Hässleholm, Sweden, 281 25
        • Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
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 Names:
  • Depo-medrol
Active Comparator: B
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 Names:
  • Depo-medrol
Placebo Comparator: C
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prövningsprotokoll 080723

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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