Cubital Tunnel SyndromeNCT02995382
Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome
A study testing Anterior Intramuscular Transposition in people with Cubital Tunnel Syndrome, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- Anterior Intramuscular Transposition
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study
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.
Read the 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:
- A generic scale, the Short Form-36
- A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)
- 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 week prior to surgery
- 1 day prior to surgery
- 3 months post surgery
- 6 months post surgery
- 12 months post surgery
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- Anterior Intramuscular Transposition
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Intramuscular TranspositionProcedure or surgery
Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow
| Study group | Role | What they receive |
|---|---|---|
| Anterior Intramuscular Transposition | Experimental | This is the only arm in our study, patients with cubital tunnel syndrome will undergo anterior intramuscular transposition, one of many surgical techniques utilized on patients with Cubital Tunnel Syndrome to alleviate symptoms. Receives: Procedure: Anterior Intramuscular Transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there improvement in Health Related Quality of Life?
HRQOL 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)
Measured: 1 week and 1 day pre-op & 3, 6, 12 months post op
Secondary outcomes (2)
Which Domains of Health Related Quality of Life Improve?
There 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)
Measured: 1 week and 1 day pre-op & 3, 6, 12 months post op
Is there improvement in physical performance?
This will be measured by using grip strength and moving 2-point discrimination
Measured: 1 week and 1 day pre-op & 3, 6, 12 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startApr 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Funding was not received and the study could not proceed without this support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew McRae, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995382
- Sponsor's protocol ID
- 2016-2361
- Status last verified
- Sep 2021
- First submitted
- 14 Dec 2016
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02995382
- Acronym / sponsor ID
- 2016-2361
- Conditions
- Cubital Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not received and the study could not proceed without this support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A generic scale, the Short Form-36
- A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)
- 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 week prior to surgery
- 1 day prior to surgery
- 3 months post surgery
- 6 months post surgery
- 12 months post surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Intramuscular Transposition | Experimental | Procedure: Anterior Intramuscular TranspositionThis is the only arm in our study, patients with cubital tunnel syndrome will undergo anterior intramuscular transposition, one of many surgical techniques utilized on patients with Cubital Tunnel Syndrome to alleviate symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Intramuscular TranspositionAnterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow | Procedure or surgery | Anterior Intramuscular Transposition |
Primary outcome
Is there improvement in Health Related Quality of Life?
Time frame: 1 week and 1 day pre-op & 3, 6, 12 months post op
HRQOL 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)
2 secondary outcomes
Which Domains of Health Related Quality of Life Improve?
Time frame: 1 week and 1 day pre-op & 3, 6, 12 months post op
Is there improvement in physical performance?
Time frame: 1 week and 1 day pre-op & 3, 6, 12 months post op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No. Data will not be shared to other researchers
Related trials for Cubital Tunnel Syndrome
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Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew McRae, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Intramuscular Transposition in people with Cubital Tunnel Syndrome, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is there improvement in Health Related Quality of Life? (time frame: 1 week and 1 day pre-op & 3, 6, 12 months post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.