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Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome

NCT02652390 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2018-10-22

Study results available
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Summary

Between 2008 and 2012 the investigators performed a single-center randomized double-blind placebo-controlled trial to assess the efficacy of local injection of two different doses of methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18 to 70 years, not previously treated with steroid injection. The primary outcomes were change in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3 groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.

Conditions

  • Carpal Tunnel Syndrome

Interventions

DRUG

Methylprednisolone 80 mg

2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

DRUG

Methylprednisolone 40 mg

1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

OTHER

Saline

2 mL saline + 1 mL lidocaine

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-10-31
Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652390 on ClinicalTrials.gov