Bilateral vs Unilateral CTR

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Daniel Osei, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01961011
First received: October 8, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

Carpal tunnel release is a well accepted treatment for median nerve compression at the wrist. With a prevalence of 50 per 1000, it is the most common compressive neuropathy. With a number of anatomic as well as systemic factors playing a role in the development of carpal tunnel syndrome, it is not surprising that there is a high incidence of bilaterality with this disease. Padua et al. reported that 87% of 266 consecutive cases had signs and symptoms of carpal tunnel syndrome in their contralateral hand.

In patients who have bilateral carpal tunnel syndrome that has not responded to conservative treatment, surgical release is indicated. In such cases, a decision must be made whether to offer bilateral simultaneous surgical release or to stage the two affected hands to allow time to recover from each.

The purpose of this study is to determine the differences in short term disability between having bilateral vs unilateral carpal tunnel release. With better understanding of the way in which patients are impaired, better recommendations may be made on which patients to indicate for simultaneous bilateral procedures and who would benefit from staging procedures, allowing the patient to recover from one hand prior to proceeding to surgery on the other hand.


Condition
Carpal Tunnel Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Simultaneous Bilateral Versus Unilateral Carpal Tunnel Release: A Prospective Comparison of Early Pain and Limitations in Activities of Daily Living

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in QuickDASH score [ Time Frame: 10 days, 30 days ] [ Designated as safety issue: No ]
    The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.


Secondary Outcome Measures:
  • World Health Organization Health and Performance Questionnaire [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The WHO HPQ is a self-reported instrument designed to estimate the workplace costs of health problems in terms of reduced job performance, sickness absence, and work-related accidents-injuries.


Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort #1: Bilateral carpal tunnel release
Cohort #1: Patients undergoing simultaneous bilateral carpal tunnel release for treatment of bilateral carpal tunnel syndrome. Inclusion criteria includes any adult patient indicated for bilateral carpal tunnel release. Exclusion criteria include age less than 18, pregnancy, any protected patient population, and the lack of assistance at home during the early postoperative period.
Cohort #2: Unilateral carpal tunnel release
Cohort #2: Patients undergoing unilateral carpal tunnel release fir bilateral carpal tunnel syndrome. Patients will chose which hand they wish to have operated on. Patient will plan on undergoing carpal tunnel release on the unoperated side at a later date. Inclusion criteria include any adult patient indicated for unilateral carpal tunnel release. Exclusion criteria include age less than 18, pregnancy, and any protected patient population.

Detailed Description:

Carpal tunnel syndrome is the most common compressive neuropathy, occurring in 0.1 to 3% of the population. The incidence is reported to be higher in certain at risk populations. 87% of individuals exhibit bilateral symptoms. In patients who fail conservative treatment, surgery is indicated. To date, it is not know whether patients benefit from undergoing simultaneous or consecutive carpal tunnel release. Some patients express concern that having both hands operated on may make it impossible to perform necessary activities of daily living in the early postoperative period. Other patients express concern that having two surgeries increases their out of pocket cost, their total disability time, and lengthens the amount of time to resolution of preoperative symptoms. One previous study has attempted to characterize the differences in the effect on activities of daily living of these two treatment paradigms. This study was limited by the fact that there was no comparison group to the study cohort.

Cohort #1: Patients undergoing simultaneous bilateral carpal tunnel release. Inclusion criteria includes any adult patient indicated for bilateral carpal tunnel release. Exclusion criteria include age less than 18, pregnancy, any protected patient population, and the lack of assistance at home during the early postoperative period.

Cohort #2: Patients undergoing unilateral carpal tunnel release. Inclusion criteria include any adult patient indicated for unilateral carpal tunnel release. Exclusion criteria include age less than 18, pregnancy, and any protected patient population.

Once a patient has been identified in the clinic the consent process will begin. Consent will be administered by a member of the research team. Being part of this investigation will not change the standard treatment of carpal tunnel syndrome in any way. After surgery, patients will go home and be asked to fill out the Quick DASH, Levine-Katz Severity Score, WHO HPQ, and SF-6D on pre-operatively and at their first post-operative visit. They will also fill out an activities of daily living log that asks the patient to rate on a scale from 1 to 5 how much difficulty he or she has with each task on the list. The patient will return their ADL log to their physician on their first postoperative visit. A final postoperative visit will occur at 1 month. The investigational questionnaires will be filled out one last time at that visit. No long term follow up is required. Patients will be contacted on their first post-operative day to ensure receipt of the daily log, the day prior to the first post operative visit as a reminder to bring the log into clinic, and on the day before their last post-operative visit thanking them for participation in the study. During their final phone call patients will be asked what factors contributed to their decision to proceed or not proceed with undergoing bilateral carpal tunnel release.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients presenting to a tertiary care orthopedic practice with bilateral carpal tunnel syndrome

Criteria

Inclusion Criteria

- any adult patient indicated for bilateral carpal tunnel release after having failed nonoperative treatment.

Exclusion Criteria

  • age less than 18
  • pregnancy
  • any protected patient population
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961011

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63130
Sponsors and Collaborators
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Daniel Osei, Assistant Professor of Orthopedic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01961011     History of Changes
Other Study ID Numbers: 201206073
Study First Received: October 8, 2013
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
nerve compression, carpal tunnel, clinical decision making

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

ClinicalTrials.gov processed this record on October 22, 2014