Carpal Tunnel SyndromeNCT03779958
Alternatives to Hand Therapy for Hand Surgery Patients
An observational study of Carpal Tunnel Syndrome and Trigger Finger, run by Stanford University at 1 site in United States.
Trial summary
Patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Trigger Finger, Ganglion Cysts
- What is being tested?
- Mobile App
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2019to Jun 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting to a single hand surgery clinic
Who may be able to join
- patients undergoing the following procedures: carpal tunnel release, trigger finger release, distal radius fracture fixation, de quervains release, cyst excision, finger fracture fixation
- smart phone that is compatible with the app
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
Patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery.
Read the detailed description
Patients who are undergoing the included procedures will be informed of the study \& consented. They will be given information on how to download the app \& input their surgery date. The app will guide the patient through various hand therapy exercises and ask them to record their QuickDASH, PSFS and VAS Pain weekly.
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger, Ganglion Cysts, Distal Radius Fracture, Finger Fracture, De Quervain Syndrome
- Being tested
- Mobile App
- Medical subject headings
- Carpal Tunnel Syndrome, Trigger Finger Disorder, Ganglion Cysts, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile AppOther
a mobile app that demonstrates hand therapy exercises
| Study group | Role | What they receive |
|---|---|---|
| Study Group | All patients will be given information about a mobile app to use during the recovery period to assist with hand therapy activities Receives: Other: Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
QuickDASH
The QD is a short form of the DASH, which measures disability of the arm, shoulder and hand. it is scored 0-100, with higher scores indicating higher disability
Measured: once a week for 6 weeks
Secondary outcomes (2)
Patient Specific Functional Scale
the PSFS is a validated measure of disability, that is scored on a 0-10 scale with lower scored indicating higher disability.
Measured: once a week for 6 weeks
VAS Pain
VAS pain is a validated measure of pain, scored 0-10, with higher scores indicating higher pain
Measured: once a week for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start12 Jan 2019
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (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
- Investigators
- Robin N Kamal, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779958
- Sponsor's protocol ID
- 47777
- Status last verified
- Jul 2021
- First submitted
- 17 Dec 2018
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Alternatives to Hand Therapy for Hand Surgery Patients
- ClinicalTrials.gov ID
- NCT03779958
- Acronym / sponsor ID
- 47777
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger, Ganglion Cysts, Distal Radius Fracture, Finger Fracture, De Quervain Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistics (Research Staffing)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Dec 2018 (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.
Patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery.
Detailed description
Patients who are undergoing the included procedures will be informed of the study \& consented. They will be given information on how to download the app \& input their surgery date. The app will guide the patient through various hand therapy exercises and ask them to record their QuickDASH, PSFS and VAS Pain weekly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Mobile AppAll patients will be given information about a mobile app to use during the recovery period to assist with hand therapy activities |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting to a single hand surgery clinic
Key inclusion criteria (2 listed)
- patients undergoing the following procedures: carpal tunnel release, trigger finger release, distal radius fracture fixation, de quervains release, cyst excision, finger fracture fixation
- smart phone that is compatible with the app
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 |
|---|---|---|
| Mobile Appa mobile app that demonstrates hand therapy exercises | Other | Study Group |
Primary outcome
QuickDASH
Time frame: once a week for 6 weeks
The QD is a short form of the DASH, which measures disability of the arm, shoulder and hand. it is scored 0-100, with higher scores indicating higher disability
2 secondary outcomes
Patient Specific Functional Scale
Time frame: once a week for 6 weeks
VAS Pain
Time frame: once a week for 6 weeks
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
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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.
Robin N Kamal, MD principal investigator
Stanford University
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 and Trigger Finger, 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 2 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?
QuickDASH (time frame: once a week for 6 weeks). 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.