Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?

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]

Study Overview

• Status: Withdrawn
• Conditions: Pain; Carpal Tunnel Syndrome

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Bilateral CTS patients undergoing bilateral carpal tunnel release

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Bilateral Carpal Tunnel Syndrome (CTS)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion: September 1, 2016

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (ESTIMATE): July 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in overall pain intensity of pain between sides.
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 2009P001019 AME 339