Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: protocol of a randomized double-blind placebo-controlled trial (NCT 00806871).
BACKGROUND
Patients with idiopathic carpal tunnel syndrome (CTS) are commonly treated with steroid injection into or proximal to the carpal tunnel. However, evidence for its efficacy beyond one month has not been established in randomized placebo-controlled trials. The primary aim of this randomized trial is to assess the efficacy of steroid injection into the carpal tunnel in relieving symptoms of CTS in patients with symptoms of such severity to warrant surgical treatment but have not been treated with steroid injection.


METHODS
The study is a randomized double-blind placebo-controlled trial. Patients referred to one orthopedic department because of CTS are screened. Eligibility criteria are age 18 to 70 years, clinical diagnosis of primary idiopathic CTS and abnormal nerve conduction tests or clinical diagnosis made independently by two orthopedic surgeons, failed treatment with wrist splinting, symptom severity of such magnitude that the patient is willing to undergo surgery, no severe sensory loss or thenar muscle atrophy, and no previous steroid injection for CTS. A total of 120 patients will be randomized to injection of 80 mg Methylprednisolone, 40 mg Methylprednisolone, or normal saline, each also containing 10 mg Lidocaine. Evaluation at baseline and at 5, 10, 24 and 52 weeks after injection includes validated questionnaires (CTS symptom severity scale, QuickDASH and SF-6D), adverse events, physical examination by a blinded assessor, and nerve conduction tests. The primary outcome measures are change in the CTS symptom severity score at 10 weeks and the rate of surgery at 52 weeks. The secondary outcome measures are the score change in the CTS symptom severity scale at 52 weeks, time to surgery, and change in QuickDASH and SF-6D scores and patient satisfaction at 10 and 52 weeks. The primary analysis will be carried out using mixed model analysis of repeated measures.


CONCLUSIONS
This paper describes the rationale and design of a double-blind, randomized placebo-controlled trial that aims to determine the efficacy of two different doses of steroid injected into the carpal tunnel in patients with moderately severe idiopathic CTS.


BACKGROUND
Clinicaltrials.gov identifier NCT00806871.
Flondell
Magnus
M
Department of Orthopedics, Hässleholm and Kristianstad Hospitals, SE-28125 Hässleholm, Sweden. magnus.flondell@med.lu.se
Hofer
Manfred
M
Björk
Jonas
J
Atroshi
Isam
I
D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D050824:Carpal Joints / Q000187:drug effects* / Q000503:physiopathology; D002349:Carpal Tunnel Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D002986:Clinical Trials as Topic / Q000379:methods*; D004185:Disability Evaluation; D004311:Double-Blind Method; D004568:Electrodiagnosis; D005260:Female; D006801:Humans; D007270:Injections, Intra-Articular / Q000379:methods; D008297:Male; D008475:Median Nerve / Q000187:drug effects / Q000503:physiopathology; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D009431:Neural Conduction / Q000187:drug effects / Q000502:physiology; D017063:Outcome Assessment, Health Care / Q000379:methods; D010808:Physical Examination / Q000379:methods; D010919:Placebos; D012107:Research Design / Q000592:standards*; D011795:Surveys and Questionnaires; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D010919:Placebos; D008775:Methylprednisolone
Arthroscopy. 2006 Sep;22(9):919-24, 924.e1-2
16952718
J Hand Surg Am. 1990 Mar;15(2):360-3
2324471
Cochrane Database Syst Rev. 2003;(1):CD003219
12535461
JAMA. 1999 Jul 14;282(2):153-8
10411196
JAMA. 2002 Sep 11;288(10):1245-51
12215131
J Hand Surg Eur Vol. 2007 Apr;32(2):198-202
17223234
Clin Orthop Relat Res. 1996 May;(326):135-45
8620634
BMC Musculoskelet Disord. 2006 May 18;7:44
16709254
J Hand Surg Am. 1999 Mar;24(2):398-404
10194028
Med Care. 1990 Jul;28(7):632-42
2366602
Arthritis Rheum. 2005 Feb;52(2):612-9
15692981
J Hand Surg Am. 1992 Nov;17(6):1160-1
1430960
Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001554
17443508
J Hand Surg Am. 2003 Jul;28(4):639-44
12877853
Acta Orthop Scand. 1998 Feb;69(1):82-8
9524525
Neurology. 2009 Jan 6;72(1):33-41
19122028
J Bone Joint Surg Am. 1993 Nov;75(11):1585-92
8245050
Lakartidningen. 2007 Oct 3-9;104(40):2884-6
17966804
BMJ. 2006 Jun 24;332(7556):1473
16777857