Overview

Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome

Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Region Skane
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- Primary idiopathic CTS

- Symptoms of classic or probable CTS according to the Katz diagnostic criteria
(numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers)

- Failed treatment with wrist splinting (2 months)

- Nerve conduction tests showing median neuropathy at the wrist or, if normal, two
orthopedic surgeons independently make CTS diagnosis

- Symptom severity that warranted referral for consideration for surgery

Exclusion Criteria:

- Previous steroid injection for CTS

- Thenar muscle atrophy

- Sensory deficit (two-point discrimination >8 mm)

- Diabetes, thyroid disorder, or inflammatory disease

- Polyneuropathy or vibration-induced neuropathy

- Current pregnancy

- Previous carpal tunnel surgery on the study hand

- Surgery on the contralateral hand in the past 2 months

- Inability to respond to questionnaires

- Severe medical illness

- Known drug/alcohol abuse