Carpal Tunnel SyndromeCTSNCT05275816
Appropriateness of Carpal Tunnel Syndrome Management Compared With the AAOS Appropriate Use Criteria
An observational study of Carpal Tunnel Syndrome, run by Hamad Medical Corporation.
Trial summary
Purpose: Carpal tunnel syndrome (CTS) is a common peripheral nerve entrapment disorder among adults that causes upper-extremity disability. The American Academy of Orthopedic Surgeons (AAOS) developed an evidence-based appropriate use criteria (AUC) for the management of CTS. 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?
- Comparing the appropriateness of our practice and the usability of the AUC through comparing the actual management provided at our institution with that recommended by the AUC.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Aug 2022
- 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: All adult patients presented to HGH or Bone and Joint Center and were diagnosed with carpal tunnel syndrome. Patients will be selected from computer-based case logs of HGH and Bone and Joint Centre in Doha, Qatar. The eligibility criteria were according to the AUC criteria for CTS management in adults.
Who may be able to join
- Adult patients (≥ 18 years) who were diagnosed with CTS.
Who cannot join
- Acute carpal tunnel syndrome
- Untreated inflammatory arthritis
- Untreated diabetes
- Thyroid disease
- Pernicious Anemia
- Patients with a known space-occupying lesion in the carpal tunnel
- Failed treatment after surgery
- Pediatric and adolescent patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Appropriateness of Carpal Tunnel Syndrome Management Compared With the AAOS Appropriate Use Criteria: A Retrospective Review Across Various Specialties
Purpose: Carpal tunnel syndrome (CTS) is a common peripheral nerve entrapment disorder among adults that causes upper-extremity disability. The American Academy of Orthopedic Surgeons (AAOS) developed an evidence-based appropriate use criteria (AUC) for the management of CTS. This study aims to assess the appropriateness of our practice and the usability of the AUC by comparing the actual management provided at our institution with that recommended by the AUC.
Methods: A retrospective review of the electronic medical records at our hospital will be performed between 1 Jan 2016 and 31 Dec 2019. Data will be collected by two authors independently. The collected data will be input into the AUC application to determine the rate of the appropriateness of the treatments. Afterwards, the agreement between the actual treatment provided and the AUC recommendation will be assessed. The primary outcome will be the appropriateness rate. Descriptive statistics such as the mean, range and percentage will be used to summarize the patients' demographics and treatment options.
Read more
Results: The appropriateness rating (appropriate, maybe, or rarely appropriate) for each treatment will be described with percentages. Similarly, the agreement of the treatments implemented at our institution with the AUC recommendations will be expressed as a proportion. A subgroup analysis within the same cohort compared the appropriateness rates of surgical release of patients across different surgical specialties using chi2 test.
Conclusion: This study will show if the management provided at our institution were appropriate and in agreement with the AUC recommendations. Additionally, it will test the usability of AUC for carpal tunnel syndrome as a valuable and practical tool that can be applied in clinical settings.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Comparing the appropriateness of our practice and the usability of the AUC through comparing the actual management provided at our institution with that recommended by the AUC.
- Keywords
- Carpal tunnel syndrome, Management, Hand Surgery
- 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.
Comparing the appropriateness of our practice and the usability of the AUC through comparing the actual management provided at our institution with that recommended by the AUC.Other
The AUC application for carpal tunnel syndrome management requires four patients' variables to generate appropriateness ratings for six different treatment options. Each procedure is rated as appropriate, maybe appropriate, or rarely appropriate. The six procedures include splint, steroid injection, carpal tunnel release, oral steroids or Ketoprofen phonophoresis, investigation of alternative diagnoses, and further investigation using an electro-diagnostic study.
To judge the usability of the AUC for the management of carpal tunnel syndrome, the required parameters of each patient were collected and entered into the AUC application by two independent authors to generate the appropriateness rating of the provided treatment for each patient. Afterwards, the agreement between the AUC recommendations and the actual treatment that was provided at our institution was assessed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of appropriateness of CTS management in our practice compared to the AUC recommendation
AUC Appropriateness rate (percentage/Continuous outcome): The AUC application for carpal tunnel syndrome management requires four patients' variables to generate appropriateness ratings for six different treatment options. Each procedure is rated as appropriate, maybe appropriate, or rarely appropriate. The six procedures include splint, steroid injection, carpal tunnel release, oral steroids or Ketoprofen phonophoresis, investigation of alternative diagnoses, and further investigation using an electro-diagnostic study.
To judge the appropriateness of the AUC for the management of carpal tunnel syndrome, the required parameters of each patient were collected and entered into the AUC application by two independent authors to generate the appropriateness rating of the provided treatment for each patient. Afterwards, the agreement between the AUC recommendations and the actual treatment that was provided at our institution was assessed.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionAug 2022 (estimated)
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 Hamad Medical CorporationThe 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
- Retrospective
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275816
- Sponsor's protocol ID
- MRC-01-22-085
- Acronym
- CTS
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriateness of Carpal Tunnel Syndrome Management Compared With the AAOS Appropriate Use Criteria: A Retrospective Review Across Various Specialties
- ClinicalTrials.gov ID
- NCT05275816
- Acronym / sponsor ID
- CTS / MRC-01-22-085
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, Management, Hand Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 11 Mar 2022 (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.
Purpose: Carpal tunnel syndrome (CTS) is a common peripheral nerve entrapment disorder among adults that causes upper-extremity disability. The American Academy of Orthopedic Surgeons (AAOS) developed an evidence-based appropriate use criteria (AUC) for the management of CTS. This study aims to assess the appropriateness of our practice and the usability of the AUC by comparing the actual management provided at our institution with that recommended by the AUC.
Methods: A retrospective review of the electronic medical records at our hospital will be performed between 1 Jan 2016 and 31 Dec 2019. Data will be collected by two authors independently. The collected data will be input into the AUC application to determine the rate of the appropriateness of the treatments. Afterwards, the agreement between the actual treatment provided and the AUC recommendation will be assessed. The primary outcome will be the appropriateness rate. Descriptive statistics such as the mean, range and percentage will be used to summarize the patients' demographics and treatment options.
Results: The appropriateness rating (appropriate, maybe, or rarely appropriate) for each treatment will be described with percentages. Similarly, the agreement of the treatments implemented at our institution with the AUC recommendations will be expressed as a proportion. A subgroup analysis within the same cohort compared the appropriateness rates of surgical release of patients across different surgical specialties using chi2 test.
Conclusion: This study will show if the management provided at our institution were appropriate and in agreement with the AUC recommendations. Additionally, it will test the usability of AUC for carpal tunnel syndrome as a valuable and practical tool that can be applied in clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients presented to HGH or Bone and Joint Center and were diagnosed with carpal tunnel syndrome. Patients will be selected from computer-based case logs of HGH and Bone and Joint Centre in Doha, Qatar. The eligibility criteria were according to the AUC criteria for CTS management in adults.
Key inclusion criteria (1 listed)
- Adult patients (≥ 18 years) who were diagnosed with CTS.
Key exclusion criteria (8 listed)
- Acute carpal tunnel syndrome
- Untreated inflammatory arthritis
- Untreated diabetes
- Thyroid disease
- Pernicious Anemia
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 |
|---|---|---|
| Comparing the appropriateness of our practice and the usability of the AUC through comparing the actual management provided at our institution with that recommended by the AUC.The AUC application for carpal tunnel syndrome management requires four patients' variables to generate appropriateness ratings for six different treatment options. Each procedure is rated as appropriate, maybe appropriate, or rarely appropriate. The six procedures include splint, steroid injection, carpal tunnel release, oral steroids or Ketoprofen phonophoresis, investigation of alternative diagnoses, and further investigation using an electro-diagnostic study. To judge the usability of the AUC for the management of carpal tunnel syndrome, the required parameters of each patient were collected and entered into the AUC application by two independent authors to generate the appropriateness rating of the provided treatment for each patient. Afterwards, the agreement between the AUC recommendations and the actual treatment that was provided at our institution was assessed. | Other | – |
Primary outcome
The rate of appropriateness of CTS management in our practice compared to the AUC recommendation
Time frame: 4 months
AUC Appropriateness rate (percentage/Continuous outcome): The AUC application for carpal tunnel syndrome management requires four patients' variables to generate appropriateness ratings for six different treatment options. Each procedure is rated as appropriate, maybe appropriate, or rarely appropriate. The six procedures include splint, steroid injection, carpal tunnel release, oral steroids or Ketoprofen phonophoresis, investigation of alternative diagnoses, and further investigation using an electro-diagnostic study. To judge the appropriateness of the AUC for the management of carpal tunnel syndrome, the required parameters of each patient were collected and entered into the AUC application by two independent authors to generate the appropriateness rating of the provided treatment for each patient. Afterwards, the agreement between the AUC recommendations and the actual treatment that was provided at our institution was assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Hamad Medical Corporation.
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 8 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: status not confirmed, as of the sponsor's last update on 11 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loay Salman, MBBS, MSc (0097470000262, LSalman2@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of appropriateness of CTS management in our practice compared to the AUC recommendation (time frame: 4 months). 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 11 Mar 2022.