Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
112 participants
INTERVENTIONAL
2008-11-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
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
B
Methylprednisolone 80 mg
Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use.
2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine
C
Sodium chloride
Saline solution 0,9%, injection in the carpal tunnel, one time use
1 ml 10 mg Lidocaine + 2 ml saline
Interventions
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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
Methylprednisolone 80 mg
Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use.
2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine
Sodium chloride
Saline solution 0,9%, injection in the carpal tunnel, one time use
1 ml 10 mg Lidocaine + 2 ml saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Isam Atroshi, MD, PhD
Role: STUDY_CHAIR
Lund university, department of clinical sciences, Hässleholm hospital, department of orthopedics
Locations
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Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK
Hässleholm, , Sweden
Countries
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References
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Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. doi: 10.1001/jama.282.2.153.
Atroshi I, Gummesson C, Johnsson R, McCabe SJ, Ornstein E. Severe carpal tunnel syndrome potentially needing surgical treatment in a general population. J Hand Surg Am. 2003 Jul;28(4):639-44. doi: 10.1016/s0363-5023(03)00148-5.
Wintman BI, Winters SC, Gelberman RH, Katz JN. Carpal tunnel release. Correlations with preoperative symptomatology. Clin Orthop Relat Res. 1996 May;(326):135-45.
Ahlberg J, Johansson H, Widenfalk B. [Disabling injuries following carpal tunnel syndrome surgery]. Lakartidningen. 2007 Oct 3-9;104(40):2884-6. No abstract available. Swedish.
Benson LS, Bare AA, Nagle DJ, Harder VS, Williams CS, Visotsky JL. Complications of endoscopic and open carpal tunnel release. Arthroscopy. 2006 Sep;22(9):919-24, 924.e1-2. doi: 10.1016/j.arthro.2006.05.008.
Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.
Hofer M, Ranstam J, Atroshi I. Extended Follow-up of Local Steroid Injection for Carpal Tunnel Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2130753. doi: 10.1001/jamanetworkopen.2021.30753.
Atroshi I, Flondell M, Hofer M, Ranstam J. Methylprednisolone injections for the carpal tunnel syndrome: a randomized, placebo-controlled trial. Ann Intern Med. 2013 Sep 3;159(5):309-17. doi: 10.7326/0003-4819-159-5-201309030-00004.
Flondell M, Hofer M, Bjork J, Atroshi I. Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: protocol of a randomized double-blind placebo-controlled trial (NCT 00806871). BMC Musculoskelet Disord. 2010 Apr 21;11:76. doi: 10.1186/1471-2474-11-76.
Other Identifiers
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prövningsprotokoll 080723
Identifier Type: -
Identifier Source: org_study_id
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