Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05275816
Other study ID # MRC-01-22-085
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2022
Est. completion date August 2022

Study information

Verified date March 2022
Source Hamad Medical Corporation
Contact Loay Salman, MBBS, MSc
Phone 0097470000262
Email LSalman2@hamad.qa
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 136
Est. completion date August 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (= 18 years) who were diagnosed with CTS. Exclusion Criteria as per the AUC: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hamad Medical Corporation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
4 months
See also
  Status Clinical Trial Phase
Completed NCT05067205 - Minimal Invasive Carpal Tunnel Release With the Novel Device N/A
Completed NCT03184688 - Platelet Rich Plasma for Carpal Tunnel Syndrome N/A
Completed NCT03582735 - Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome N/A
Completed NCT05490420 - Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome N/A
Recruiting NCT05970692 - Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Completed NCT04043780 - Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome N/A
Completed NCT03880812 - Cost Information on Carpal Tunnel Syndrome Treatment Decisions N/A
Recruiting NCT05503719 - An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial N/A
Recruiting NCT05328180 - aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE) N/A
Recruiting NCT05372393 - Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block N/A
Recruiting NCT05466162 - Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome N/A
Completed NCT04060875 - Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Not yet recruiting NCT06294821 - 4AP to Delay Carpal Tunnel Release (CTR) Phase 2/Phase 3
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Terminated NCT02791529 - Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release Phase 1
Completed NCT02141035 - Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome Phase 2/Phase 3
Completed NCT01887145 - Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome N/A
Recruiting NCT01897272 - Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study N/A
Completed NCT01394822 - Neuromuscular Ultrasound for Focal Neuropathies N/A
Enrolling by invitation NCT01017471 - Carpal Tunnel Syndrome Release Using PSU Retractor Phase 3