Clinical Trial: Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational [Patient Registry]

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

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 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:<

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Overall Pain Intensity [ Time Frame: 2 weeks after surgery within 6 month timeframe ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: June 10, 2014
Date Started: July 2014
Date Completion: September 2016
Last Updated: February 2, 2017
Last Verified: February 2017