Clinical trial NCT00806871: Steroid Injection Treatment of Carpal Tunnel Syndrome
Official title: Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: www.biomedcentral.com/1471-2474/11/76

Eligibility criteria: 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

Primary outcomes:
measure: The CTS symptom severity score after treatment.
timeFrame: 10 weeks
measure: Rate of surgery
timeFrame: 52 weeks
Secondary outcomes:
measure: The CTS symptom severity score after treatment
timeFrame: 52 weeks
measure: Time to surgery
timeFrame: 52 weeks
measure: QuickDASH score
timeFrame: 52 weeks
measure: SF-6D score
timeFrame: 52 weeks
measure: Patient satisfaction with the results of treatment (VAS scale)
timeFrame: 52 weeks
measure: Registration of adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hässleholm
country: Sweden
facility: Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK
Study officials:
affiliation: Lund university, department of clinical sciences, Hässleholm hospital, department of orthopedics
name: Isam Atroshi, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: Wintman BI, Winters SC, Gelberman RH, Katz JN. Carpal tunnel release. Correlations with preoperative symptomatology. Clin Orthop Relat Res. 1996 May;(326):135-45.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.