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Steroid Injection Treatment of Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Methylprednisolone 40 mg

Methylprednisolone 80 mg

Sodium chloride

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

The CTS symptom severity score after treatment.

Rate of surgery

Secondary Outcome Measures

The CTS symptom severity score after treatment

Time to surgery

QuickDASH score

SF-6D score

Patient satisfaction with the results of treatment (VAS scale)

Registration of adverse events

Full Information

NCT ID

NCT00806871

First Posted

December 10, 2008

Last Updated

April 3, 2012

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT00806871

Brief Title

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

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone 40 mg

Other Intervention Name(s)

Depo-medrol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone 80 mg

Other Intervention Name(s)

Depo-medrol

Intervention Description

Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use. 2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine

Intervention Type

Drug

Intervention Name(s)

Sodium chloride

Other Intervention Name(s)

Saline, NaCl

Intervention Description

Saline solution 0,9%, injection in the carpal tunnel, one time use 1 ml 10 mg Lidocaine + 2 ml saline

Primary Outcome Measure Information:

Title

The CTS symptom severity score after treatment.

Time Frame

10 weeks

Title

Rate of surgery

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

The CTS symptom severity score after treatment

Time Frame

52 weeks

Title

Time to surgery

Time Frame

52 weeks

Title

QuickDASH score

Time Frame

52 weeks

Title

SF-6D score

Time Frame

52 weeks

Title

Patient satisfaction with the results of treatment (VAS scale)

Time Frame

52 weeks

Title

Registration of adverse events

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isam Atroshi, MD, PhD

Organizational Affiliation

Lund university, department of clinical sciences, Hässleholm hospital, department of orthopedics

Official's Role

Study Chair

Facility Information:

Facility Name

Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK

City

Hässleholm

ZIP/Postal Code

281 25

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

10411196

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.

Results Reference

background

PubMed Identifier

12877853

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.

Results Reference

background

PubMed Identifier

8620634

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.

Results Reference

background

PubMed Identifier

17966804

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.

Results Reference

background

PubMed Identifier

16952718

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.

Results Reference

background

PubMed Identifier

17443508

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.

Results Reference

background

PubMed Identifier

34677593

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.

Results Reference

derived

PubMed Identifier

24026316

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.

Results Reference

derived

PubMed Identifier

20409331

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.

Results Reference

derived

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Steroid Injection Treatment of Carpal Tunnel Syndrome

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