Carpal Tunnel SyndromeNCT04693273
Novel Decision Aid for Carpal Tunnel Patients
An observational study of Carpal Tunnel Syndrome, run by Henry Ford Health System at 1 site in United States.
Trial summary
A questionnaire will be given to patients who are considering undergoing hand surgery as a treatment for Carpal Tunnel Syndrome to help participants decide between two surgical options- Wide-Awake-Local-Anesthesia-no-Tourniquet (WALANT) and traditional open hand surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Decision Aid for Surgical Modality Choice
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 20 Jan 2021
- Phase
- Observational
- 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
Study population: Patients who are CTR candidates will be asked to participate in this study considering such patients are 18 years or older, comprehend and read English, and considering the participation depends on passing the orientation, concentration, and memory test.
Who may be able to join
- 18 years of older,
- CTS patients who are CTR candidates,
- Comprehend and understand English,
- Passed the Orientation-memory-concentration test done before the decision aid
Who cannot join
- Younger than 18 years of age,
- Non-CTS patients,
- Not CTR candidates,
- Do not comprehend or read English,
- Failed the Orientation-memory-concentration test done before the decision aid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Decision Aid for Carpal Tunnel Patients: Exploring Patient Preferences Between WALANT and Traditional Surgery
A questionnaire will be given to patients who are considering undergoing hand surgery as a treatment for Carpal Tunnel Syndrome to help participants decide between two surgical options- Wide-Awake-Local-Anesthesia-no-Tourniquet (WALANT) and traditional open hand surgery. These patients will be asked to complete a pre-questionnaire knowledge test and a post-questionnaire knowledge test. the primary objective is to validate this questionnaire to be used by other orthopedic surgeons. This study will also reveal patient preference between these two surgical treatments for carpal tunnel syndrome.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Decision Aid for Surgical Modality Choice
- Keywords
- WALANT, Wide-Awake-Local-Anesthesia-no-Tourniquet
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid for Surgical Modality ChoiceOther
A novel decision aid that helps surgical patients choose between Wide-Awake carpal tunnel release and traditional tourniquet surgery. It involves an orientation-memory-concentration test to test if patients are cognitively capable of making decisions, then the decision aid table that has similarities and differences between the two modalities, and a few survey questions that help the investigators know what the patients prefer. Finally, patients finish the decision conflict test to see how confident these patients are about their preference.
| Study group | Role | What they receive |
|---|---|---|
| Carpal Tunnel Release surgical patients | This is the group the investigators survey who are candidates for carpal tunnel release (CTR) surgery: patients should be 18 years or older, comprehend and read English, and patients who consent to do the survey. Receives: Other: Decision Aid for Surgical Modality Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Modality preference for CTR through questionnaire answers
Investigators will reveal participants' preferences regarding the preferred surgical modality between WALANT and traditional tourniquet by having a questionnaire question after participants read the decision aid whereby such participants are asked whether their preference is WALANT or traditional tourniquet carpal tunnel release after having learned about both.
Measured: Feb, 2020- Feb, 2021
Secondary outcomes (3)
Patient Knowledge scores Before the decision aid use
This is achieved through 4 multiple-choice questions (the score is out of 4) that are completed by the patient before reading the decision aid. The questions revolve around concepts relevant to wide-awake and traditional-tourniquet carpal tunnel release surgical modalities. These questions assess the patient's prior knowledge.
Measured: Feb, 2020- Feb, 2021
Patient knowledge scores after the decision aid use
This is achieved through 4 multiple-choice questions (the score is out of 4) that are completed by the patient after reading the decision aid. They are the same questions as those done before the decision aid but aim to test if the patient truly understood and learned from the decision tool. This knowledge score along with the score of the questions done before the decision aid will help assess if a significant enhancement of the knowledge scores happened which reflects a useful decision aid.
Measured: Feb, 2020- Feb, 2021
Decisional Conflict Score
A previously validated scale was used which involves several questions assessing how confident the patient is about the decision/preference declared and how much it resembles their values. Patients are asked to assess their agreement/disagreement on several factors on the scale using a Likert scale between 0 (confident) and 4 (not confident ). The lower the aggregate score, the more confident the participant is. Per the scale's manual, a score of 25 or lower reflects a confident patient while any score over 36 reflects decisional hesitation or conflict. (This is the reference for the decisional scale's manual that is used in the study: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf)
Measured: Feb, 2020- Feb, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start12 Feb 2020
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles S Day, Henry Ford Health System
- Investigators
- Charles S Day, M.D., M.B.A., Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693273
- Sponsor's protocol ID
- 13583
- Status last verified
- Aug 2021
- First submitted
- 16 Dec 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient information will be de-identified and then will be deleted after completion of the study. Patient information will not be shared with others.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Decision Aid for Carpal Tunnel Patients: Exploring Patient Preferences Between WALANT and Traditional Surgery
- ClinicalTrials.gov ID
- NCT04693273
- Acronym / sponsor ID
- 13583
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- WALANT, Wide-Awake-Local-Anesthesia-no-Tourniquet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- 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.
A questionnaire will be given to patients who are considering undergoing hand surgery as a treatment for Carpal Tunnel Syndrome to help participants decide between two surgical options- Wide-Awake-Local-Anesthesia-no-Tourniquet (WALANT) and traditional open hand surgery. These patients will be asked to complete a pre-questionnaire knowledge test and a post-questionnaire knowledge test. the primary objective is to validate this questionnaire to be used by other orthopedic surgeons. This study will also reveal patient preference between these two surgical treatments for carpal tunnel syndrome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel Release surgical patients | – | Other: Decision Aid for Surgical Modality ChoiceThis is the group the investigators survey who are candidates for carpal tunnel release (CTR) surgery: patients should be 18 years or older, comprehend and read English, and patients who consent to do the survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are CTR candidates will be asked to participate in this study considering such patients are 18 years or older, comprehend and read English, and considering the participation depends on passing the orientation, concentration, and memory test.
Key inclusion criteria (4 listed)
- 18 years of older,
- CTS patients who are CTR candidates,
- Comprehend and understand English,
- Passed the Orientation-memory-concentration test done before the decision aid
Key exclusion criteria (5 listed)
- Younger than 18 years of age,
- Non-CTS patients,
- Not CTR candidates,
- Do not comprehend or read English,
- Failed the Orientation-memory-concentration test done before the decision aid
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 |
|---|---|---|
| Decision Aid for Surgical Modality ChoiceA novel decision aid that helps surgical patients choose between Wide-Awake carpal tunnel release and traditional tourniquet surgery. It involves an orientation-memory-concentration test to test if patients are cognitively capable of making decisions, then the decision aid table that has similarities and differences between the two modalities, and a few survey questions that help the investigators know what the patients prefer. Finally, patients finish the decision conflict test to see how confident these patients are about their preference. | Other | Carpal Tunnel Release surgical patients |
Primary outcome
Surgical Modality preference for CTR through questionnaire answers
Time frame: Feb, 2020- Feb, 2021
Investigators will reveal participants' preferences regarding the preferred surgical modality between WALANT and traditional tourniquet by having a questionnaire question after participants read the decision aid whereby such participants are asked whether their preference is WALANT or traditional tourniquet carpal tunnel release after having learned about both.
3 secondary outcomes
Patient Knowledge scores Before the decision aid use
Time frame: Feb, 2020- Feb, 2021
Patient knowledge scores after the decision aid use
Time frame: Feb, 2020- Feb, 2021
Decisional Conflict Score
Time frame: Feb, 2020- Feb, 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No. Patient information will be de-identified and then will be deleted after completion of the study. Patient information will not be shared with others.
Related trials for Carpal Tunnel Syndrome
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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.
Charles S Day, M.D., M.B.A. principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Henry Ford Health System at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical Modality preference for CTR through questionnaire answers (time frame: Feb, 2020- Feb, 2021). 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 26 Aug 2021.