Carpal Tunnel SyndromeNCT02587897
Musculoskeletal Health of the Upper Extremity in Emerging Health Professionals
An observational study of Carpal Tunnel Syndrome, run by University of Southern California at 3 sites in United States.
Trial summary
Carpal tunnel syndrome is the most expensive upper extremity work-related musculoskeletal disorder, impacting 10 million people annually and costing employers up to $113,695 per incident. There is currently no established method to detect this disorder prior to the onset of symptoms and nerve damage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Academic Coursework and Work-Related Hand Activities
- How many people
- 176 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2016to 7 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will enroll a total of 120 dental hygiene students from the University of Southern California (USC) and Loma Linda University (LLU), as well as 60 occupational therapy students from USC.
Who may be able to join
- Enrollment in one of the academic programs (i.e., register and pay for classes)
Who cannot join
- <18 years of age
- Prior carpal tunnel release surgery
- Prior diagnosis of median nerve pathology or other poly-neuropathy that includes the median nerve
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Loma Linda Univeristy Dental Hygiene Program
Loma Linda, California, 92350
USC Musculsokeletal Sonography & Occupational Performance Laboratory
Los Angeles, California, 90033
USC Dental Hygiene
Los Angeles, California, 90089
About this study
Official title: Sonographic Tissue Morphology in Early Stage Work-related Median Nerve Pathology
Carpal tunnel syndrome is the most expensive upper extremity work-related musculoskeletal disorder, impacting 10 million people annually and costing employers up to $113,695 per incident. There is currently no established method to detect this disorder prior to the onset of symptoms and nerve damage. Preliminary research suggests that sonography-a relatively inexpensive, widely available, increasingly portable technology-can provide a non-invasive and pain-free method of early detection that could reduce incidence, improve targeted interventions and ultimately reduce costs. The primary aims of this study are to establish predictive validity of a novel method for early detection using sonographic imaging and to identify task components of intensive functional hand activity associated with morphologic changes.
Read the detailed description
This longitudinal study will follow dental hygiene students-a high-risk population with minimal retrospective and controlled prospective task exposure-for two years and compare them to a non-exposed cohort of occupational therapy students to investigate the primary aims. This research is directed at the National Occupational Research Agenda's (NORA) Healthcare and Social Assistance sector with a focus on the National Institute of Occupational Safety and Health's (NIOSH) Exposure Assessment and Musculoskeletal Disorders cross-sectors. Intermediate outcomes of this research will establish sonographic imaging as an early detection tool for workplace-screening and inform methods for combining measures of nerve morphology, neurophysiology, and subjective symptoms for predicting the development of work-related carpal tunnel syndrome. This work will also inform the development of targeted preventive interventions for task components of intensive hand activities that are related to changes in tissue morphology. Identifying morphologic changes in early-stages of pathology and the specific task components linked to these changes are the first steps toward early detection and prevention of work-related carpal tunnel syndrome.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Academic Coursework, Work-Related Hand Activities
- Keywords
- Ultrasonography, Nerve Conduction Velocity, Ergonomics, Work Related Injury, Cumulative Trauma Disorders
- Medical subject headings
- Carpal Tunnel Syndrome, Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic CourseworkOther
Didactic training provided by the university through coursework and laboratory training that meets requirements of the accreditation standards provided by the professional society associated with each professional degree granting program.
Work-Related Hand ActivitiesOther
Exposure to intensive training in the use of dental scaling tools as part of laboratory courses, as well as fieldwork and residency training during the academic degree program.
| Study group | Role | What they receive |
|---|---|---|
| Dental Hygiene Students | Students enrolled in the 2-year dental hygiene academic coursework programs at the University of Southern California and Loma Linda University who are exposed to high-intensity work-related hand activities as part of their training program. Receives: Other: Academic Coursework; Other: Work-Related Hand Activities | |
| Occupational Therapy Students | Students enrolled in the 2-year occupational therapy academic coursework program at the University of Southern California. Receives: Other: Academic Coursework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years
Measured: Baseline and 2 years
Secondary outcomes (6)
Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 1 year
Measured: Baseline and 1 year
Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 2 years
Measured: Baseline and 2 years
Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 1 year
Measured: Baseline and 1 year
Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 2 years
Measured: Baseline and 2 years
Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 1 year
Nerve conduction velocity testing of the median nerve includes physiological measurement of the ability of the nerve to conduct electrical signals using nerve conduction testing equipment (Sierra Wave) with a surface stimulator at the wrist and surface electrodes on the second and fifth digits.
Measured: Baseline and 1 year
Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 2 years
Nerve conduction velocity testing of the median nerve includes physiological measurement of the ability of the nerve to conduct electrical signals using nerve conduction testing equipment (Sierra Wave) with a surface stimulator at the wrist and surface electrodes on the second and fifth digits.
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJul 2016
- Primary completion27 Mar 2020
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC), Loma Linda University, National Center for Dental Hygiene Research and Practice
- Responsible party
- Principal investigator, Shawn Roll, University of Southern California
- Investigators
- Shawn C Roll, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587897
- Sponsor's protocol ID
- HS-15-00004
- Other IDs
- 1R01OH010665-01A1
- Status last verified
- Sep 2023
- First submitted
- 23 Oct 2015
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Once manuscripts from the project become available, datasets used to produce manuscripts will be shared with individual peers under the auspices of the PI. Only de-identified data in final databases, will be shared; raw data will not be shared. Data from secondary analyses beyond the specific aims will only be shared under the auspices of the investigators involved. When authorized, data will be made available to requestors under a data-sharing agreement that provides for: (1) using the data for research only, (2) securing the data using appropriate techniques, (3) destroying or returning the data after analyses are completed, and (4) providing the PI with a summary of how the data were used. Requestors agree to protect the intellectual property rights of the PI, or other investigators as indicted, by appropriately acknowledging the source of the data in any document or presentation, which may include oversight or authorship on work that is based substantially on the shared data.
Publications
Roll SC, Tung KD, Chang H, Sehremelis TA, Fukumura YE, Randolph S, Forrest JL. Prevention and rehabilitation of musculoskeletal disorders in oral health care professionals: A systematic review. J Am Dent Assoc. 2019 Jun;150(6):489-502. doi: 10.1016/j.adaj.2019.01.031. Epub 2019 Apr 25.
PubMed 31030935Takata SC, Kysh L, Mack WJ, Roll SC. Sonographic reference values of median nerve cross-sectional area: a protocol for a systematic review and meta-analysis. Syst Rev. 2019 Jan 3;8(1):2. doi: 10.1186/s13643-018-0929-9.
PubMed 30606255Yao B, Evans KD, Roll SC. Assessing the Potential for Error in Investigating Intraneural Vascularity: A Need for a Standardized Imaging Protocol. J Diagn Med Sonogr. 2023 Nov;39(6):549-559. doi: 10.1177/87564793231193396.
PubMed 38074490Fang Y, Kapellusch JM, Baker NA, Roll SC. CHARACTERIZING PHYSICAL STRAIN IN NON-ROUTINIZED CLINICAL WORK THROUGH OBSERVATION: AN EXAMPLE OF ORAL HEALTHCARE PROVIDERS. Proc Int Symp Hum Factors Ergon Healthc. 2024 Sep;13(1):134-139. doi: 10.1177/2327857924131015.
PubMed 39430719Loomis KJ, Roll SC. External wrist ratio is not a proxy for internal carpal tunnel shape: Implications for evaluating carpal tunnel syndrome risk. Clin Anat. 2024 Nov;37(8):869-877. doi: 10.1002/ca.24132. Epub 2024 Jan 3.
PubMed 38173294Yao B, Gan K, Lee A, Roll SC. Comparing Shape Categorization to Circularity Measurement in the Evaluation of Median Nerve Compression Using Sonography. J Diagn Med Sonogr. 2020;2020:10.1177/8756479319898471. doi: 10.1177/8756479319898471. Epub 2020 Jan 8.
PubMed 32064465Takata SC, Roll SC. Identification of Aberrant Muscle Bellies in the Carpal Tunnel using Sonography. J Diagn Med Sonogr. 2019 Jan;35(1):62-68. doi: 10.1177/8756479318807469. Epub 2018 Oct 20.
PubMed 30397686Pozzi F, Sousa CO, Plummer HA, Andrade B, Awokuse D, Kono N, Mack WJ, Roll SC, Michener LA. Development of shoulder pain with job-related repetitive load: mechanisms of tendon pathology and anxiety. J Shoulder Elbow Surg. 2022 Feb;31(2):225-234. doi: 10.1016/j.jse.2021.09.007. Epub 2021 Oct 14.
PubMed 34656782Yao B, Roll SC. An ultrasound study of the mobility of the median nerve during composite finger movement in the healthy young wrist. Muscle Nerve. 2022 Jan;65(1):82-88. doi: 10.1002/mus.27437. Epub 2021 Oct 27.
PubMed 34648193Yao B, Takata SC, Mack WJ, Roll SC. Modeling extracurricular activity participation with physical and mental health in college students over time. J Am Coll Health. 2023 May-Jun;71(4):1232-1240. doi: 10.1080/07448481.2021.1926263. Epub 2021 Jul 9.
PubMed 34242536Roll SC, Hardison ME, Forrest JL, Colclazier NL, Sumi JY, Baker NA. A standardized protocol for the comprehensive assessment of dental hygiene work. Work. 2021;69(3):1041-1052. doi: 10.3233/WOR-213534.
PubMed 34219697Fang Y, Tung KD, Beleno-Sanchez J, Forrest JL, Roll SC. Characterization of Tasks and Time Efficiency of Dental Hygiene Students During Clinical Training. J Dent Hyg. 2020 Oct;94(5):30-37.
PubMed 33008947Roll SC, Takata SC, Yao B, Kysh L, Mack WJ. Sonographic reference values for median nerve cross-sectional area: A meta-analysis of data from healthy individuals. J Diagn Med Sonogr. 2023 Sep;39(5):492-506. doi: 10.1177/87564793231176009. Epub 2023 Jun 6.
PubMed 37654772
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Tissue Morphology in Early Stage Work-related Median Nerve Pathology
- ClinicalTrials.gov ID
- NCT02587897
- Acronym / sponsor ID
- HS-15-00004
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Ultrasonography, Nerve Conduction Velocity, Ergonomics, Work Related Injury, Cumulative Trauma Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC), Loma Linda University, National Center for Dental Hygiene Research and Practice
- Study start
- Jul 2016 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 27 Oct 2015 (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.
Carpal tunnel syndrome is the most expensive upper extremity work-related musculoskeletal disorder, impacting 10 million people annually and costing employers up to $113,695 per incident. There is currently no established method to detect this disorder prior to the onset of symptoms and nerve damage. Preliminary research suggests that sonography-a relatively inexpensive, widely available, increasingly portable technology-can provide a non-invasive and pain-free method of early detection that could reduce incidence, improve targeted interventions and ultimately reduce costs. The primary aims of this study are to establish predictive validity of a novel method for early detection using sonographic imaging and to identify task components of intensive functional hand activity associated with morphologic changes.
Detailed description
This longitudinal study will follow dental hygiene students-a high-risk population with minimal retrospective and controlled prospective task exposure-for two years and compare them to a non-exposed cohort of occupational therapy students to investigate the primary aims. This research is directed at the National Occupational Research Agenda's (NORA) Healthcare and Social Assistance sector with a focus on the National Institute of Occupational Safety and Health's (NIOSH) Exposure Assessment and Musculoskeletal Disorders cross-sectors. Intermediate outcomes of this research will establish sonographic imaging as an early detection tool for workplace-screening and inform methods for combining measures of nerve morphology, neurophysiology, and subjective symptoms for predicting the development of work-related carpal tunnel syndrome. This work will also inform the development of targeted preventive interventions for task components of intensive hand activities that are related to changes in tissue morphology. Identifying morphologic changes in early-stages of pathology and the specific task components linked to these changes are the first steps toward early detection and prevention of work-related carpal tunnel syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental Hygiene Students | – | Other: Academic Coursework, Other: Work-Related Hand ActivitiesStudents enrolled in the 2-year dental hygiene academic coursework programs at the University of Southern California and Loma Linda University who are exposed to high-intensity work-related hand activities as part of their training program. |
| Occupational Therapy Students | – | Other: Academic CourseworkStudents enrolled in the 2-year occupational therapy academic coursework program at the University of Southern California. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll a total of 120 dental hygiene students from the University of Southern California (USC) and Loma Linda University (LLU), as well as 60 occupational therapy students from USC.
Key inclusion criteria (1 listed)
- Enrollment in one of the academic programs (i.e., register and pay for classes)
Key exclusion criteria (3 listed)
- <18 years of age
- Prior carpal tunnel release surgery
- Prior diagnosis of median nerve pathology or other poly-neuropathy that includes the median nerve
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 |
|---|---|---|
| Academic CourseworkDidactic training provided by the university through coursework and laboratory training that meets requirements of the accreditation standards provided by the professional society associated with each professional degree granting program. | Other | Dental Hygiene Students, Occupational Therapy Students |
| Work-Related Hand ActivitiesExposure to intensive training in the use of dental scaling tools as part of laboratory courses, as well as fieldwork and residency training during the academic degree program. | Other | Dental Hygiene Students |
Primary outcome
Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years
Time frame: Baseline and 2 years
6 secondary outcomes
Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 1 year
Time frame: Baseline and 1 year
Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 2 years
Time frame: Baseline and 2 years
Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 1 year
Time frame: Baseline and 1 year
Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 2 years
Time frame: Baseline and 2 years
Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 1 year
Time frame: Baseline and 1 year
Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 2 years
Time frame: Baseline and 2 years
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 28 Jan 2025.
- Background: PubMed 31030935Roll SC, Tung KD, Chang H, Sehremelis TA, Fukumura YE, Randolph S, Forrest JL. Prevention and rehabilitation of musculoskeletal disorders in oral health care professionals: A systematic review. J Am Dent Assoc. 2019 Jun;150(6):489-502. doi: 10.1016/j.adaj.2019.01.031. Epub 2019 Apr 25.
- Background: PubMed 30606255Takata SC, Kysh L, Mack WJ, Roll SC. Sonographic reference values of median nerve cross-sectional area: a protocol for a systematic review and meta-analysis. Syst Rev. 2019 Jan 3;8(1):2. doi: 10.1186/s13643-018-0929-9.
- Results publication: PubMed 38074490Yao B, Evans KD, Roll SC. Assessing the Potential for Error in Investigating Intraneural Vascularity: A Need for a Standardized Imaging Protocol. J Diagn Med Sonogr. 2023 Nov;39(6):549-559. doi: 10.1177/87564793231193396.
- Results publication: PubMed 39430719Fang Y, Kapellusch JM, Baker NA, Roll SC. CHARACTERIZING PHYSICAL STRAIN IN NON-ROUTINIZED CLINICAL WORK THROUGH OBSERVATION: AN EXAMPLE OF ORAL HEALTHCARE PROVIDERS. Proc Int Symp Hum Factors Ergon Healthc. 2024 Sep;13(1):134-139. doi: 10.1177/2327857924131015.
- Results publication: PubMed 38173294Loomis KJ, Roll SC. External wrist ratio is not a proxy for internal carpal tunnel shape: Implications for evaluating carpal tunnel syndrome risk. Clin Anat. 2024 Nov;37(8):869-877. doi: 10.1002/ca.24132. Epub 2024 Jan 3.
- Results publication: PubMed 32064465Yao B, Gan K, Lee A, Roll SC. Comparing Shape Categorization to Circularity Measurement in the Evaluation of Median Nerve Compression Using Sonography. J Diagn Med Sonogr. 2020;2020:10.1177/8756479319898471. doi: 10.1177/8756479319898471. Epub 2020 Jan 8.
- Results publication: PubMed 30397686Takata SC, Roll SC. Identification of Aberrant Muscle Bellies in the Carpal Tunnel using Sonography. J Diagn Med Sonogr. 2019 Jan;35(1):62-68. doi: 10.1177/8756479318807469. Epub 2018 Oct 20.
- Results publication: PubMed 34656782Pozzi F, Sousa CO, Plummer HA, Andrade B, Awokuse D, Kono N, Mack WJ, Roll SC, Michener LA. Development of shoulder pain with job-related repetitive load: mechanisms of tendon pathology and anxiety. J Shoulder Elbow Surg. 2022 Feb;31(2):225-234. doi: 10.1016/j.jse.2021.09.007. Epub 2021 Oct 14.
- Results publication: PubMed 34648193Yao B, Roll SC. An ultrasound study of the mobility of the median nerve during composite finger movement in the healthy young wrist. Muscle Nerve. 2022 Jan;65(1):82-88. doi: 10.1002/mus.27437. Epub 2021 Oct 27.
- Results publication: PubMed 34242536Yao B, Takata SC, Mack WJ, Roll SC. Modeling extracurricular activity participation with physical and mental health in college students over time. J Am Coll Health. 2023 May-Jun;71(4):1232-1240. doi: 10.1080/07448481.2021.1926263. Epub 2021 Jul 9.
- Results publication: PubMed 34219697Roll SC, Hardison ME, Forrest JL, Colclazier NL, Sumi JY, Baker NA. A standardized protocol for the comprehensive assessment of dental hygiene work. Work. 2021;69(3):1041-1052. doi: 10.3233/WOR-213534.
- Results publication: PubMed 33008947Fang Y, Tung KD, Beleno-Sanchez J, Forrest JL, Roll SC. Characterization of Tasks and Time Efficiency of Dental Hygiene Students During Clinical Training. J Dent Hyg. 2020 Oct;94(5):30-37.
- Individual participant dataSharing planned: Yes. Once manuscripts from the project become available, datasets used to produce manuscripts will be shared with individual peers under the auspices of the PI. Only de-identified data in final databases, will be shared; raw data will not be shared. Data from secondary analyses beyond the specific aims will only be shared under the auspices of the investigators involved. When authorized, data will be made available to requestors under a data-sharing agreement that provides for: (1) using the data for research only, (2) securing the data using appropriate techniques, (3) destroying or returning the data after analyses are completed, and (4) providing the PI with a summary of how the data were used. Requestors agree to protect the intellectual property rights of the PI, or other investigators as indicted, by appropriately acknowledging the source of the data in any document or presentation, which may include oversight or authorship on work that is based substantially on the shared data.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Shawn C Roll, PhD principal investigator
University of Southern California
3 sites 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 University of Southern California at 3 sites 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 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: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years (time frame: Baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587897, which also lists 13 linked publications.
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 28 Jan 2025.