Viewing Study NCT02198521



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Last Modification Date: 2024-10-26 @ 11:28 AM
Study NCT ID: NCT02198521
Status: WITHDRAWN
Last Update Posted: 2017-02-03
First Post: 2014-06-10

Brief Title: Staged Bilateral Carpal Tunnel Release Which Side Hurts More
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

Official Title: Staged Bilateral Carpal Tunnel Release Which Side Hurts More
Status: WITHDRAWN
Status Verified Date: 2017-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The researcher and principal investigator working on this study left the institution
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Title Staged Bilateral Carpal Tunnel Release Which Side Hurts More Primary null hypothesis Patients undergoing staged bilateral open Carpal Tunnel Release CTR have no difference in overall pain intensity of pain between sides

Secondary null hypotheses

There is no correlation in overall pain intensity after open CTR surgery and distal sensory latency distal motor latency electromyography EMG demographics occupation avocation relevant comorbidities dominance left vs right Pain Self-Efficacy Patient Reported Outcomes Measurement Information System PROMIS Upper Extremity or PROMIS depression when both surgeries are performed within 6 months
There is no difference in satisfaction with treatment at the time of suture removal after the first and second open CTR surgery when both are performed within 6 months

IRB 2009-p-001-019 ClinicalTrialsgov Not mandatory bo observational Authors Drijkoningen Braun Ring Journal To be discussed Design Prospective cohort study Background Many hand surgeons note that patients undergoing staged bilateral open carpal tunnel release often experience more pain with the second side The investigator felt this was an easily testable hypothesis worthy of study

Subjects

Eligibility

Inclusion

Age 18 or older
Idiopathic carpal tunnel syndrome
No prior surgery for carpal tunnel syndrome

Exclude

Pregnant women
Not fluent in English

Response Variables

11-point ordinal measure of overall pain intensity during and after surgery measured at the time of suture removal
11-point ordinal measure of satisfaction with treatment
PROMIS upper extremity

Explanatory Variables

Distal Sensory Latency DSL
Distal Motor Latency DML
EMG changes
Demographics age sex race occupation avocation
Time limit between two surgeries 6 months
Relevant comorbidities Trapeziometacarpal TMC arthrosis ulnar neuropathy trigger finger
Involved hand Dominance Side
First side vs second side surgery
PROMIS Pain Interference Computer Adaptive Testing CAT
Pain Self Efficacy Questionnaire PSEQ-2
PROMIS Depression

Methods The investigator and study staff will invite all adult patients age 18 and older presenting to the Orthopaedic Hand and Upper Extremity Service Department at Massachusetts General Hospital MGH with bilateral carpal tunnel syndrome planning staged bilateral carpal tunnel release

Analysis Power analysis An a priori power analysis for matched pairs was performed To detect the difference between two dependent means an effect size of 05 at alpha of 005 and 80 power a total sample size of 34 patients is neededAs the investigator expects to have patients who will be lost to follow-up the investigators will count 10 extra a total of 38 patients will be needed

Univariate analysis Variables will be presented with frequencies and percentages for categorical variables and as mean with standard deviation or median with interquartile range for respectively normal or non-normal distributed continuous variables Normality of continuous distributed variables will be tested a paired T-Test

Bivariate and multivariable analysis will be performed and subsequently all variables with a probability 010 in bivariate analysis will be inserted in a backward stepwise multivariable linear regression analysis to assess their ability to explain variation in outcome The 11 point Likert Pain scale score is considered significant when there is a difference of more than 14 points 28 SD05 effect sizeon a scale from 1-109
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None