Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02788734
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
University of Iowa
Information provided by (Responsible Party):
University of South Florida

Tracking Information
First Submitted Date May 27, 2016
First Posted Date June 2, 2016
Last Update Posted Date March 15, 2018
Study Start Date June 2016
Actual Primary Completion Date November 19, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2016)
  • 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
  • The Disability of Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 2 months ]
    30 item scale which assesses symptoms and physical function
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02788734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Reported Outcomes Measures (PROM) in Carpal Tunnel Therapies in Patients With Inherited Neuropathies
Official Title Patient Reported Outcomes Measures (PROM) in Carpal Tunnel Therapies in Patients With Inherited Neuropathies
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.
Detailed Description

An online survey will be used to assess outcomes in conservative and surgical therapies used for carpal tunnel syndrome (CTS) in patients with a diagnosis of inherited neuropathy such as CMT or HNPP (Charcot-Marie-Tooth disease and Hereditary Neuropathy with liability to Pressure Palsies respectively). HNPP is an inherited neuropathy which is allelic to CMT1A. This patient reported outcome measurement will also assess symptom severity and functional status related to carpal tunnel syndrome (CTS) in various types of patients with inherited neuropathy.

The survey incorporates two validated questionnaires for the evaluation of outcomes related to carpal tunnel syndrome. The Boston Carpal Tunnel Questionnaire (BCTQ) is very specific to carpal tunnel syndrome (CTS). The Disability of Arm, Shoulder and Hand (DASH) questionnaire is less specific for CTS but has been shown to have equal validity in the assessment of outcomes in CTS. The relative non-specificity of DASH for CTS can be useful in assessing the possible contribution of CMT to the overall upper extremity symptom severity and functional outcome. Data collected from participants with a diagnosis or therapies for CTS can be compared to data collected from participants with no diagnosis or therapies for CTS.

Furthermore, the study will incorporate components from the CMTNS to assess the extent of CMT disease in the participants.

It is proposed that a retrospective analysis of patients with CMT who have symptoms in the upper extremities suggestive of carpal tunnel syndrome. Two validated questionnaires exploring changes in symptoms and functional status (BCTQ and DASH) can be used in evaluating outcomes of patients with reported symptoms or diagnosis of carpal tunnel syndrome.

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. BCTQ has established test-retest reliability with a good Pearson's correlation of scores on re-test (0.91 for the symptoms severity component and 0.93 for the functional status component of the test). High internal consistency has also been reported for the BCTQ (0.88-9.92). Convergent validity has been demonstrated with high correlation between pre- and postoperative BCTQ scores and physical measures such as grip, key pinch and three-jaw pinch. Responsiveness of the BCTQ after carpal tunnel surgery has been demonstrated in randomized clinical trial settings. BCTQ has also been reported to be 2-4 times more responsive to clinical improvement in comparison to measures of neuromuscular impairment. High response rates have been reported with BCTQ with 80-93% at 6-12 weeks follow-up and between 67-93% at 6-12 months follow-up after carpal tunnel release. Response rates remained high at 85% at 2 years follow-up. Mailed follow-up response rate of 69% has been reported with a mean follow-up of 4.8 years. The mean time to complete BCTQ has been reported to be 5.6 minutes. There is no data to indicate the precision of BCTQ in relation to carpal tunnel syndrome.

The Disability of Arm, Shoulder and Hand (DASH) questionnaire is a 30 item scale which assesses symptoms and physical function. This questionnaire is not specific for carpal tunnel and can be used for a variety of disorders affecting the upper limb. DASH is intended to measure disability through an emphasis on upper extremity activity. The test-retest reliability of DASH has been demonstrated with a Pearson's 8 correlation of 0.9 in a group of patients with carpal tunnel syndrome.

The validity of DASH was demonstrated through correlation with BCTQ. Pre- and postoperative DASH scores also correlate with physical measures such as grip, key pinch and three-jaw pinch. Responsiveness through improved DASH scores has been demonstrated at three and six months post-surgery follow-up. BCTQ was found to be more responsive to DASH for carpal tunnel syndrome. Postal mail response rates have been shown to be 80-93% at 6-12 weeks and 66-98% at 6 months after carpal tunnel release. The mean time to complete DASH is reported to be 6.8 minutes. There is no data to indicate the precision of DASH in relation to carpal tunnel syndrome.

The survey data will be stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. Names or other personal health information will not be collected. Upon conclusion of the study period, the data will be sent to Dr. Michael Shy, principal investigator of the Inherited Neuropathies Consortium. Deidentified data will be sent to the database of Genotypes and Phenotypes (dbGaP).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Carpal Tunnel Syndrome
  • Charcot-Marie-Tooth Disease
  • Inherited Peripheral Neuropathy
Intervention 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.
Study Groups/Cohorts INC Contact Registry
INC Contact Registry will complete the online questionnaires
Intervention: Other: Web-based survey
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 18, 2016)
333
Original Estimated Enrollment
 (submitted: May 27, 2016)
200
Actual Study Completion Date November 19, 2016
Actual Primary Completion Date November 19, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02788734
Other Study ID Numbers INC6612
U01TR001263 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of South Florida
Study Sponsor University of South Florida
Collaborators
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Rochester
  • University of Iowa
Investigators
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
PRS Account University of South Florida
Verification Date March 2017