Nerve Entrapment in Diabetic Patients - Full Text View

Sponsored by:	Malmö University Hospital
Information provided by:	Malmö University Hospital
ClinicalTrials.gov Identifier:	NCT00775333

Purpose

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.

Condition	Intervention
Carpal Tunnel Syndrome Entrapment Neuropathies Nerve Compression Syndromes Diabetes Complications	Procedure: Outcome after carpal tunnel release

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome Charcot-Marie-Tooth Disease Diabetes Diabetes Complications Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Clinical Outcomes of Surgical Release Among Diabetic Patients With Carpal Tunnel Syndrome. A Prospective Study With Matched Controls

Further study details as provided by Malmö University Hospital:

Primary Outcome Measures:

Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength) [ Time Frame: Baseline, 6 weeks, 12 weeks, 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pillar pain, cold intolerance, and patient satisfaction. [ Time Frame: Baseline, 6 weeks, 12 weeks, 52 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	67
Study Start Date:	December 2003
Study Completion Date:	April 2008

Groups/Cohorts	Assigned Interventions
1 Patients with diabetes and carpal tunnel syndrome
2 Non-diabetic patients with carpal tunnel syndrome	Procedure: Outcome after carpal tunnel release Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients referred to a specialized hand clinic

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775333

Locations

Sweden
Dept. of Hand Surgery, Malmo University Hospital
Malmo, Sweden, 205 02

Sponsors and Collaborators

Malmö University Hospital

Investigators

Principal Investigator:

Lars Dahlin, PHD

Unaffiliated

More Information

No publications provided

Responsible Party:	Dept. of Hand Surgery, Malmo University Hospital, Sweden ( Niels Thomsen, MD )
Study ID Numbers:	LU 508-03
Study First Received:	October 17, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00775333 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Malmö University Hospital:

Carpal Tunnel Syndrome
Diabetes
APB strength
Sensory Function

Pillar Pain
Cold Intolerance
Patient Satisfaction

Study placed in the following topic categories:

Tooth Diseases
Roussy Levy Hereditary Areflexic Dystasia
Carpal Tunnel Syndrome
Nervous System Malformations
Disorders of Environmental Origin
Pain
Neurodegenerative Diseases
Mononeuropathies
Heredodegenerative Disorders, Nervous System
Neuromuscular Diseases
Hereditary Motor and Sensory Neuropathies
Congenital Abnormalities
Diabetes Complications

Charcot Marie Tooth Disease
Charcot-Marie-Tooth Disease
Wounds and Injuries
Diabetes Mellitus
Polyneuropathies
Endocrine System Diseases
Tomaculous Neuropathy
Nerve Compression Syndromes
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Endocrinopathy
Cumulative Trauma Disorders
Sprains and Strains

Additional relevant MeSH terms:

Carpal Tunnel Syndrome
Nervous System Malformations
Disorders of Environmental Origin
Neurodegenerative Diseases
Mononeuropathies
Heredodegenerative Disorders, Nervous System
Pathologic Processes
Neuromuscular Diseases
Syndrome
Hereditary Motor and Sensory Neuropathies
Congenital Abnormalities
Diabetes Complications
Median Neuropathy

Disease
Nervous System Diseases
Charcot-Marie-Tooth Disease
Wounds and Injuries
Polyneuropathies
Diabetes Mellitus
Endocrine System Diseases
Nerve Compression Syndromes
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Sprains and Strains
Cumulative Trauma Disorders

ClinicalTrials.gov processed this record on May 07, 2009