Carpal Tunnel SyndromeNCT03909373
Validation of PSFS in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Stanford University at 1 site in United States.
Trial summary
Validation of the Patient Specific Functional Scale in patients with carpal tunnel syndrome 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?
- PSFS
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 31 Dec 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 of the Principal Investigator who meet inclusion criteria
Who may be able to join
- diagnosis of carpal tunnel syndrome
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Health Care
Redwood City, California, 94063
About this study
Official title: Validation of the Patient-Specific Functional Survey in Patients With Carpal Tunnel
Validation of the Patient Specific Functional Scale in patients with carpal tunnel syndrome
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- PSFS
- 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.
PSFSOther
Patients will complete the patient specific functional scale. no intervention being administered
| Study group | Role | What they receive |
|---|---|---|
| Cohort | patients with carpal tunnel syndrome Receives: Other: PSFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Specific Functional Scale Scores
PSFS measures perceived function. Patients rate their ability to perform self-selected tasks on a 0-10 scale, with higher scores indicating higher ability.
Measured: 2 weeks after initial completion
Patient Specific Functional Scale Scores
Patients rate their ability to perform self-selected tasks on a 0-10 scale, with higher scores indicating higher ability.
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start18 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Logistics (Research Staffing)
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 Stanford 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Kamal, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909373
- Sponsor's protocol ID
- 49525
- Status last verified
- Jul 2021
- First submitted
- 7 Mar 2019
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Patient-Specific Functional Survey in Patients With Carpal Tunnel
- ClinicalTrials.gov ID
- NCT03909373
- Acronym / sponsor ID
- 49525
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistics (Research Staffing)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Apr 2019 (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.
Validation of the Patient Specific Functional Scale in patients with carpal tunnel syndrome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: PSFSpatients with carpal tunnel syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Principal Investigator who meet inclusion criteria
Key inclusion criteria (1 listed)
- diagnosis of carpal tunnel syndrome
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PSFSPatients will complete the patient specific functional scale. no intervention being administered | Other | Cohort |
Primary outcome
Patient Specific Functional Scale Scores
Time frame: 2 weeks after initial completion
PSFS measures perceived function. Patients rate their ability to perform self-selected tasks on a 0-10 scale, with higher scores indicating higher ability.
Patient Specific Functional Scale Scores
Time frame: 6 weeks after surgery
Patients rate their ability to perform self-selected tasks on a 0-10 scale, with higher scores indicating higher ability.
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 6 Aug 2021.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stanford University 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 1 inclusion and 1 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 6 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 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?
Patient Specific Functional Scale Scores (time frame: 2 weeks after initial completion). The study lists 2 primary outcomes in all. 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 6 Aug 2021.