Steroid Injection Treatment of Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806871
• Other study ID #: prövningsprotokoll 080723
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 10, 2008
• Last updated: April 3, 2012
• Start date: November 2008
• Est. completion date: April 2012

Study information

• Verified date: March 2011
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Description:

www.biomedcentral.com/1471-2474/11/76

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Sweden	Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK	Hässleholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Ahlberg J, Johansson H, Widenfalk B. [Disabling injuries following carpal tunnel syndrome surgery]. Lakartidningen. 2007 Oct 3-9;104(40):2884-6. Swedish. — View 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. — View Citation

Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosén I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. — View 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. Review. — View Citation

Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001554. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The CTS symptom severity score after treatment.		10 weeks	No
Primary	Rate of surgery		52 weeks	No
Secondary	The CTS symptom severity score after treatment		52 weeks	No
Secondary	Time to surgery		52 weeks	No
Secondary	QuickDASH score		52 weeks	No
Secondary	SF-6D score		52 weeks	No
Secondary	Patient satisfaction with the results of treatment (VAS scale)		52 weeks	No
Secondary	Registration of adverse events		24 weeks	Yes