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Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?

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ClinicalTrials.gov Identifier: NCT02198521
Recruitment Status : Withdrawn (The researcher and principal investigator working on this study left the institution.)
First Posted : July 23, 2014
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital

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:

  • 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]


Condition or disease
Carpal Tunnel Syndrome Pain

Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Staged Bilateral Carpal Tunnel Release: Which Side Hurts More?
Study Start Date : July 2014
Actual Primary Completion Date : September 2016
Study Completion Date : September 2016


Group/Cohort
Bilateral Carpal Tunnel Syndrome (CTS)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Patient Reported Outcome for Upper Extremity Function [ Time Frame: 2 weeks after surgery within 6 month timeframe ]
    PROMIS upper extremity

  3. Electromyogram Results [ Time Frame: Before Surgery ]
    EMG DSL and DML

  4. Demographics [ Time Frame: 2 weeks after first surgery ]
    Age, sex, race, occupation, avocation

  5. Comorbidities [ Time Frame: 2 weeks after surgery ]
    Relevant comorbidities: TMC Arthrosis, ulnar neuropathy, trigger finger

  6. Hand Dominance and Side of Surgery [ Time Frame: 2 weeks after surgery ]
  7. Patient Reported Pain Interference [ Time Frame: 2 weeks after surgery within 6 month timeframe ]
    PROMIS Pain Interference (CAT)

  8. Patient Self Efficacy Questionnaire [ Time Frame: 2 weeks after surgery within 6 month timeframe ]
    PSEQ-2

  9. Patient Reported Depression [ Time Frame: 2 weeks after surgery within 6 month timeframe ]
    PROMIS Depression



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Bilateral CTS patients undergoing bilateral carpal tunnel release
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198521


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: David C. Ring, MD, MD/PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02198521     History of Changes
Other Study ID Numbers: 2009P001019 AME 339
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by David C. Ring, MD, Massachusetts General Hospital:
Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in overall pain intensity of pain between sides.

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries