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]