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Patient Reported Outcomes Measures (PROM) in Carpal Tunnel Therapies in Patients With Inherited Neuropathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02788734
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : March 15, 2018
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
University of Iowa
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
The purpose of this study is to learn about focal compressive median neuropathy at the wrist (Carpal Tunnel Syndrome) and outcomes of therapies (e.g. conservative and surgery) in the upper extremities of patients diagnosed with an inherited neuropathy. All patients enrolled in the Rare Diseases Clinical Research Network (RDCRN) Inherited Neuropathies Consortium (INC) Contact Registry who have marked one of the following disorders: CMT1A, CMT1B, CMT2A, CMT4, CMTX, other known CMT peripheral neuropathy, other unknown CMT peripheral neuropathy, or Hereditary Neuropathy with liability to Pressure Palsies (HNPP), will be invited via email to participate in this online study.

Condition or disease Intervention/treatment
Carpal Tunnel Syndrome Charcot-Marie-Tooth Disease Inherited Peripheral Neuropathy Other: Web-based survey

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Study Type : Observational
Actual Enrollment : 333 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Outcomes Measures (PROM) in Carpal Tunnel Therapies in Patients With Inherited Neuropathies
Study Start Date : June 2016
Actual Primary Completion Date : November 19, 2016
Actual Study Completion Date : November 19, 2016

Group/Cohort Intervention/treatment
INC Contact Registry
INC Contact Registry will complete the online questionnaires
Other: Web-based survey
This study protocol consists of one anonymous survey. Each participant can complete only one survey. The survey will take approximately 25 minutes to complete. The survey is designed to identify items that best reflect the symptom severity and functional status in patients with CTS and CMT. A unique link to the survey will be included in an email invitation distributed to all adult CMT or HNPP patients self-registered in the RDCRN INC Contact Registry. Upon clicking the link, the participant will be directed to the IRB-approved online consent form. Upon providing consent, the participant will be directed to the online survey.

Primary Outcome Measures :
  1. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) [ Time Frame: 2 months ]
    The Boston Carpal Tunnel Questionnaire (BCTQ) is a 19 item scale which was developed specifically for carpal tunnel syndrome and consists of 11 questions to assess symptom severity and 8 questions to assess functional status

  2. The Disability of Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 2 months ]
    30 item scale which assesses symptoms and physical function

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The online survey will target adult CMT patients who have self-registered at the RDCRN Inherited Neuropathies Consortium (INC) Contact Registry, a web based contact registry developed and supported by the RDCRN Data Management and Coordinating Center (DMCC), located at the University of South Florida.

Inclusion Criteria:

  • Diagnosis of CMT or HNPP
  • Adults age 18 years and older
  • Self-Registration at the Inherited Neuropathies Consortium (INC) Contact Registry

Exclusion Criteria:

  • Inability to provide informed consent and complete survey
  • Inability to read or speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02788734

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United States, Florida
University of South Florida Health Informatics Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
University of Iowa
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Study Chair: David Herrmann, MBBCh University of Rochester
Study Chair: Michael Shy, MD University of Iowa
Study Chair: Callyn A Kirk, MSPH USF Health Informatics Institute
Study Chair: Francis Panosyan, MD, PhD University of Rochester

Publications of Results:

Other Publications:

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Responsible Party: University of South Florida Identifier: NCT02788734    
Other Study ID Numbers: INC6612
U01TR001263 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of South Florida:
carpal tunnel syndrome
inherited peripheral neuropathy
Charcot-Marie-Tooth disease
Hereditary Neuropathy
Pressure Palsies
Additional relevant MeSH terms:
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Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Tooth Diseases
Peripheral Nervous System Diseases
Carpal Tunnel Syndrome
Neuromuscular Diseases
Nervous System Diseases
Median Neuropathy
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Stomatognathic Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn