The Relationship Between Ultrasonographic Findings and Sleep Quality in Carpal Tunnel Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorAfyonkarahisar Health Sciences University
About this trial
The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients and to compare the findings with healthy controls.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients diagnosed with CTS according to the criteria of the American Academy of Neurology
Disqualifiers
Patients with radiculopathy, brachial plexopathy, thoracic outlet syndrome and traumatic nerve injury that may affect the median nerve
History of Carpal tunnel surgery
Pregnancy
Malignancy
Trial population
90 patients with CTS and 30 patients with gonarthrosis as control group, aged between 20-80 years who applied to our clinic will be included in the study.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Assessment of Sleep Quality
Other interventionAssessment of Sleep Quality
Assessment of Sleep Quality
Other interventionAssessment of Sleep Quality
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Patient Group1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS)
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
Time frame
2023.02-2023.05Secondary outcomes
1
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a frequently used questionnaire for CTS that includes 2 components. It evaluates for grading under two sub-headings: symptom severity scale (11 questions) and functional status scale (8 questions). Scores range from 0 to 5 for each question; 0 represents no difficulty during the activity, 5 represents extremely severe dysfunction.
Time frame
2023.02-2023.052
Cross-sectional area of the Median Nerve (CSA)
The cross-sectional area (CSA) of the median nerve will be used for analysis by the mean value of 3 measurements made with an electronic caliper at scaphoid-pisiform level. Ultrasonographic evaluations were planned to be performed with the 10-18-MHz linear probe of the MyLab 70 (Esaote, Genova, Italy) device by a physician experienced in US. CSA values increase as clinical findings worsen.
Time frame
2023.02-2023.053
Electrophysiological Evaluation
The patients will be evaluated as mild-moderate-severe CTS according to the criteria of the American Academy of Neurology.
Time frame
2023.02-2023.054
Hand and Finger Grip Strength Assessment
The hand grip strength of the participants will be measured with the "Jamar Hand Dynamometer". Measurements will be made with the shoulder in adduction and neutral rotation adjacent to the trunk, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumb up. Finger grip strength will be evaluated with the "Jamar Digital Pinchmeter". Patients will be placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength.
Time frame
2023.02-2023.05Sponsors and contacts
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Source ClinicalTrials.gov