NCT00775333

Brief Summary

The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

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

December 1, 2003

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
Last Updated

October 20, 2008

Status Verified

October 1, 2008

First QC Date

October 17, 2008

Last Update Submit

October 17, 2008

Conditions

Carpal Tunnel SyndromeEntrapment NeuropathiesNerve Compression SyndromesDiabetes Complications

Keywords

Carpal Tunnel SyndromeDiabetesAPB strengthSensory FunctionPillar PainCold IntolerancePatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength)

    Baseline, 6 weeks, 12 weeks, 52 weeks

Secondary Outcomes (1)

  • Pillar pain, cold intolerance, and patient satisfaction.

    Baseline, 6 weeks, 12 weeks, 52 weeks

Study Arms (2)

1

Patients with diabetes and carpal tunnel syndrome

2

Non-diabetic patients with carpal tunnel syndrome

Procedure: Outcome after carpal tunnel release

Interventions

Outcome after carpal tunnel releasePROCEDURE

Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients

2

Eligibility Criteria

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

Patients referred to a specialized hand clinic

You may qualify if:

  • Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome
  • Confirmed by nerve conduction studies.

You may not qualify if:

  • Other focal nerve entrapments
  • Cervical radiculopathy
  • Inflammatory joint disease
  • Renal failure
  • Thyroid disorders
  • Previous wrist fracture
  • Long-term exposure to vibrating tools.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Hand Surgery, Malmo University Hospital

Malmo, 205 02, Sweden

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeNerve Compression SyndromesDiabetes ComplicationsDiabetes MellitusPatient Satisfaction

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Lars Dahlin, PHD

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

December 1, 2003

Study Completion

April 1, 2008

Last Updated

October 20, 2008

Record last verified: 2008-10

Locations

SE(1)