NCT01201109

Brief Summary

The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

September 13, 2010

Last Update Submit

September 27, 2010

Conditions

Carpal Tunnel SyndromeDiabetesNerve Entrapment

Keywords

Carpal tunnel syndromeEntrapment neuropathiesDiabetes

Outcome Measures

Primary Outcomes (1)

  • Patient self-reported outcome questionnaire

    Measured by 1). Boston Carpal Tunnel Questionnaire regarding carpal tunnel symptoms and disability. 2). Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) registering health-related quality of life. 3). Cold intolerance on a CISS score

    5 years after carpal tunnel release

Secondary Outcomes (1)

  • Nerve conduction study and vibrotactile sense

    5 years after carpal tunnels release

Study Arms (2)

Diabetics

Diabetic patients operated for carpal tunnel syndrome

Non-diabetics

Non-diabetic patients operated for carpal tunnel syndrome

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective series of matched diabetic and non-diabetic patients who were operated for carapl tunnel syndrome 5 years ago.

You may qualify if:

  • diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago.

You may not qualify if:

  • previous carpal tunnel release in the hand under study
  • clinical signs of nerve entrapment other than CTS
  • cervical radiculopathy, inflammatory joint disease
  • renal failure
  • thyroid disorders
  • previous wrist fracture on the affected side
  • daily long-term exposure to vibrating tools
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Hand Surgery, Skåne University Hospital

Malmo, SE 205 02, Sweden

Location

Related Publications (1)

  • Thomsen NOB, Dahlin LB. Vibrotactile sense 5 years after carpal tunnel release in people with diabetes: A prospective study with matched controls. Diabet Med. 2021 Jul;38(7):e14453. doi: 10.1111/dme.14453. Epub 2020 Nov 26.

    PMID: 33169372DERIVED

MeSH Terms

Conditions

Carpal Tunnel SyndromeDiabetes MellitusNerve Compression Syndromes

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lars Dahlin, Md, PhD

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 28, 2010

Record last verified: 2010-09

Locations

SE(1)