Clinical trial NCT05838963: Predictive Value of Baseline CTQ-SSS Scores for Progression to Carpal Tunnel Release Surgery: A Cohort Study
Official title: Predictive Value of Baseline CTQ-SSS Scores for Progression to Carpal Tunnel Release Surgery: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with carpal tunnel syndrome who are undergoing nonsurgical management.

Brief summary: This study aims to determine the predictive value of baseline CTQ-SSS scores for progression to carpal tunnel release (CTR) surgery in patients with carpal tunnel syndrome (CTS). It will be a prospective cohort study involving at least 200 patients with CTS who are undergoing nonsurgical management. Participants will complete the CTQ-SSS and other functional measures at baseline, 3 months, 6 months, and 12 months, and the primary outcome will be progression to CTR surgery. Logistic regression models will be used to assess the predictive value of baseline CTQ-SSS scores for progression to CTR surgery, adjusting for potential confounding factors such as age, sex, and baseline symptom severity. The results of this study can help clinicians identify patients who may benefit from early surgical intervention.


Eligibility criteria: Inclusion Criteria:

* Patients with symptoms consistent with carpal tunnel syndrome, such as numbness, tingling, or pain in the hand or wrist.
* Patients with a positive nerve conduction study confirming carpal tunnel syndrome, OR patients with clinical symptoms and signs consistent with carpal tunnel syndrome if a nerve conduction study is not available or inconclusive.
* Patients who have not undergone hand or wrist surgery within the past 6 months.
* Patients who are 18 years of age or older.
* Patients who are willing and able to provide informed consent and comply with study requirements.

Exclusion Criteria:

* Patients with a history of hand or wrist surgery within the past 6 months.
* Patients with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
* Patients with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
* Patients with other neurologic or musculoskeletal disorders that could affect hand function or interfere with test completion.
* Pregnant or breastfeeding women.
* Patients who have participated in another clinical trial within the past 30 days.

Primary outcomes:
measure: Predictive value of baseline CTQ-SSS scores for progression to carpal tunnel release (CTR) surgery.
timeFrame: Participants will be followed up for a 12-month period.
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References: