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Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome

Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02995382
Enrollment
0
Registered
2016-12-16
Start date
2023-04-30
Completion date
2023-06-30
Last updated
2022-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cubital Tunnel Syndrome

Brief summary

This study aims to determine the Health Related Quality of life (HRQOL) (the physical, mental, emotional and social functioning) of patients with cubital tunnel syndrome following anterior intramuscular transposition, after one year.

Detailed description

As there are many different surgical procedures to address cubital tunnel syndrome, HRQOL will be used to determine if anterior intramuscular transposition provides patients with positive outcomes. To measure HRQOL 3 specific scales will be administered: 1. A generic scale, the Short Form-36 2. A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE) 3. A utility scale, the EuroQOL, five dimension questionnaire These scales are widely reported in the literature, are valid, reliable and easy to fill out. Using these scales we can determine HRQOL as well as Quality Adjusted Life Years, which, allows us to do a cost-utility analysis (economic evaluation) on this specific procedure. Patients will be asked to fill out the above mentioned questionnaires, as well as perform 2 performance tests (grip strength, and a moving 2-point discrimination test) at the following time points: 1. 1 week prior to surgery 2. 1 day prior to surgery 3. 3 months post surgery 4. 6 months post surgery 5. 12 months post surgery

Interventions

Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of cubital tunnel syndrome confirmed with Electromyography (EMG) testing or Ultrasound imaging * Ability to comprehend English and complete health related quality of life questionnaires * Willing to provide informed consent * Age \> 18 years * Not pregnant

Exclusion criteria

* Prior ipsilateral cubital tunnel release * Evidence of symptomatic clinical double crush syndrome confirmed by EMG/Nerve Conduction Study (NCS) * Patients with rheumatoid arthritis, connective tissue disorder, tenosynovitis, or diagnosed neurological condition that could confound the assessment of health-related quality of life with regard to the affected arm and hand

Design outcomes

Primary

MeasureTime frameDescription
Is there improvement in Health Related Quality of Life?1 week and 1 day pre-op & 3, 6, 12 months post opHRQOL will be determined using 3 questionnaires: a generic widely reported scale (SF-36), a condition specific valid and reliable scale (The PRUNE), and a utility scale EuroQol-5D)

Secondary

MeasureTime frameDescription
Which Domains of Health Related Quality of Life Improve?1 week and 1 day pre-op & 3, 6, 12 months post opThere are different domains listed in the questionnaires, depending on the response from the patients we will determine where the improvement was seen (physical, mental, emotional, etc)
Is there improvement in physical performance?1 week and 1 day pre-op & 3, 6, 12 months post opThis will be measured by using grip strength and moving 2-point discrimination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026