Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?

Study Overview
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Brief Summary
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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 ClinicalTrials.gov: Not mandatory, (b/o 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 0.5 at alpha of 0.05 and 80% power, a total sample size of 34 patients is needed.As 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 < 0.10 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 1.4 points (2.8 SD*0.5 effect size)on a scale from 1-10.[9]

Official Title
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Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?

Conditions
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Carpal Tunnel Syndrome, Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Idiopathic carpal tunnel syndrome No prior surgery for carpal tunnel syndrome Exclusion Criteria: Pregnant women Not fluent in English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bilateral Carpal Tunnel Syndrome (CTS)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Pain Intensity | The overall pain intensity is measured on an 11-point ordinal measure of overall pain intensity after surgery measured at the time of suture removal. | 2 weeks after surgery within 6 month timeframe | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Satisfaction | 11-point ordinal measure of satisfaction with treatment measured 2 weeks after surgery during suture removal | 2 weeks after surgery within a 6 month timeframe | 
| Patient Reported Outcome for Upper Extremity Function | PROMIS upper extremity | 2 weeks after surgery within 6 month timeframe | 
| Electromyogram Results | EMG DSL and DML | Before Surgery | 
| Demographics | Age, sex, race, occupation, avocation | 2 weeks after first surgery | 
| Comorbidities | Relevant comorbidities: TMC Arthrosis, ulnar neuropathy, trigger finger | 2 weeks after surgery | 
| Hand Dominance and Side of Surgery |  | 2 weeks after surgery | 
| Patient Reported Pain Interference | PROMIS Pain Interference (CAT) | 2 weeks after surgery within 6 month timeframe | 
| Patient Self Efficacy Questionnaire | PSEQ-2 | 2 weeks after surgery within 6 month timeframe | 
| Patient Reported Depression | PROMIS Depression | 2 weeks after surgery within 6 month timeframe | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in overall pain intensity of pain between sides.