Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?

Pain Clinical Trial

Official title:

Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02198521
• Other study ID #: 2009P001019 AME 339
• Status: Withdrawn
• Phase: N/A
• First received: June 10, 2014
• Last updated: February 2, 2017
• Start date: July 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 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]

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Pain

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient Reported Outcome for Upper Extremity Function	PROMIS upper extremity	2 weeks after surgery within 6 month timeframe
Secondary	Electromyogram Results	EMG DSL and DML	Before Surgery
Secondary	Demographics	Age, sex, race, occupation, avocation	2 weeks after first surgery
Secondary	Comorbidities	Relevant comorbidities: TMC Arthrosis, ulnar neuropathy, trigger finger	2 weeks after surgery
Secondary	Hand Dominance and Side of Surgery		2 weeks after surgery
Secondary	Patient Reported Pain Interference	PROMIS Pain Interference (CAT)	2 weeks after surgery within 6 month timeframe
Secondary	Patient Self Efficacy Questionnaire	PSEQ-2	2 weeks after surgery within 6 month timeframe
Secondary	Patient Reported Depression	PROMIS Depression	2 weeks after surgery within 6 month timeframe