NCT00806871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 4, 2012

Status Verified

March 1, 2011

Enrollment Period

3.4 years

First QC Date

December 10, 2008

Last Update Submit

April 3, 2012

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (2)

  • The CTS symptom severity score after treatment.

    10 weeks

  • Rate of surgery

    52 weeks

Secondary Outcomes (6)

  • The CTS symptom severity score after treatment

    52 weeks

  • Time to surgery

    52 weeks

  • QuickDASH score

    52 weeks

  • SF-6D score

    52 weeks

  • Patient satisfaction with the results of treatment (VAS scale)

    52 weeks

  • +1 more secondary outcomes

Study Arms (3)

A

ACTIVE COMPARATOR
Drug: Methylprednisolone 40 mg

B

ACTIVE COMPARATOR
Drug: Methylprednisolone 80 mg

C

PLACEBO COMPARATOR
Drug: Sodium chloride

Interventions

Methylprednisolone 40 mgDRUG

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

Also known as: Depo-medrol
A
Methylprednisolone 80 mgDRUG

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

Also known as: Depo-medrol
B
Sodium chlorideDRUG

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

Also known as: Saline, NaCl
C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK

Hässleholm, 281 25, Sweden

Location

Related Publications (9)

  • 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.

    PMID: 10411196BACKGROUND

  • 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.

    PMID: 12877853BACKGROUND

  • Wintman BI, Winters SC, Gelberman RH, Katz JN. Carpal tunnel release. Correlations with preoperative symptomatology. Clin Orthop Relat Res. 1996 May;(326):135-45.

    PMID: 8620634BACKGROUND

  • 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.

    PMID: 17966804BACKGROUND

  • 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.

    PMID: 16952718BACKGROUND

  • Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.

    PMID: 17443508BACKGROUND

  • 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.

    PMID: 34677593DERIVED

  • 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.

    PMID: 24026316DERIVED

  • 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.

    PMID: 20409331DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

MethylprednisoloneMethylprednisolone AcetateSodium Chloride

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Isam Atroshi, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 4, 2012

Record last verified: 2011-03

Locations

SE(1)