NCT00981565

Brief Summary

Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is based on symptoms, clinical findings and electrophysiological examination. Several conservative and surgical treatment options have been described. Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not been done and it is still unclear whether or not surgical treatment is better than conservative treatment. The aim of this study is to research has surgery better outcome in mild CTS than conservative treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and indirect costs will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

2 years

First QC Date

September 11, 2009

Last Update Submit

October 17, 2012

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndromeCTSmedianus impingement

Outcome Measures

Primary Outcomes (2)

  • Change in Symptom Severity Score

    1 year

  • Pain Visual Analogue Scale (VAS)

    1 year

Secondary Outcomes (1)

  • Change in electroneuromyography

    1 year

Study Arms (2)

Operative

ACTIVE COMPARATOR
Procedure: open carpal tunnel release

Conservative

ACTIVE COMPARATOR
Other: Night-cast

Interventions

open carpal tunnel releasePROCEDURE

surgery to release the carpal tunnel

Operative
Night-castOTHER

individual night time splinting

Conservative

Eligibility Criteria

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

You may qualify if:

  • electrophysiologically proven minimal or mild CTS lasting more than six months will be included in this study

You may not qualify if:

  • rheumatoid arthritis
  • diabetes mellitus
  • hypothyreosis
  • pregnancy
  • wrist trauma or previous surgery
  • splinting or corticosteroid injection on the affected side

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

North-Carelia Central Hospital

Joensuu, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Central Hospital of Mikkeli

Mikkeli, Finland

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 22, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

June 1, 2012

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

FI(3)