An observational study in Carpal Tunnel Syndrome (CTS), sponsored by Mardin Artuklu University. Not yet recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Mardin Artuklu University · Observational
Carpal tunnel syndrome can cause numbness, tingling, pain, and reduced hand function. The Phalen test is commonly used during clinical examination, but it is usually recorded only as positive or negative. The time needed for the symptoms caused by the test to return to their pre-test level may provide additional information about the clinical severity of carpal tunnel syndrome.
This study will investigate the clinical meaning of symptom recovery time after the Phalen test in adults with electrodiagnostically confirmed carpal tunnel syndrome. During the test, participants will keep their wrists fully flexed for up to 60 seconds. If typical symptoms appear or clearly increase, the test will be stopped and the wrists will be returned to a neutral position. The time required for symptoms to return to their pre-test level will be recorded.
Participants will also complete the Boston Carpal Tunnel Questionnaire and will be evaluated for nighttime symptoms and nerve conduction findings. The study will examine whether recovery time is related to hand function, symptom severity, nighttime complaints, symptom onset time during the Phalen test, and electrodiagnostic severity. A subgroup of participants with a positive Phalen test will repeat the test after 3-7 days to evaluate its test-retest reliability. No treatment will be assigned as part of this observational study.
The Phalen test is widely used in the clinical assessment of carpal tunnel syndrome. In routine practice, the test is generally interpreted as positive or negative according to whether typical symptoms occur within a defined period. However, this approach does not describe how quickly symptoms appear or how long they continue after the wrist is returned to a neutral position. Symptom recovery time may reflect functional and clinical burden that is not fully explained by electrodiagnostic severity alone.Previous studies have examined the relationship between Phalen test findings and electrodiagnostic severity; however, the clinical meaning of symptom recovery time after the test remains unclear.
This dual-center, observational, cross-sectional study will include adults with clinical symptoms of carpal tunnel syndrome confirmed by nerve conduction studies. For participants with bilateral carpal tunnel syndrome, the hand with greater nighttime paresthesia will be evaluated. If symptoms are equal in both hands, the dominant hand will be selected.
Before the Phalen test, paresthesia intensity in the evaluated hand will be recorded using a 0-10 Numeric Rating Scale. Participants will then sit with the backs of both hands placed together and the wrists held in full flexion without external pressure. The test will continue for a maximum of 60 seconds. It will be stopped immediately when typical symptoms in the median nerve distribution newly appear or clearly increase. The time from the beginning of the test to symptom onset will be recorded in seconds.
After the test is stopped, the participant will return the wrists to a neutral position and a second timer will be started. Symptom recovery time will be defined as the time required for the provoked symptoms to return to their pre-test level. Recovery will be observed for up to 300 seconds. If typical symptoms do not occur within 60 seconds, the Phalen test will be classified as negative and recovery time will not be defined.
Clinical symptom severity and hand function will be evaluated using the Boston Carpal Tunnel Questionnaire. Nighttime symptoms will be assessed using the number of carpal tunnel syndrome-related awakenings during the previous seven nights, nighttime numbness or tingling intensity, and the duration of morning numbness. Nerve conduction findings and electrodiagnostic severity will be collected as part of the study assessment.
The primary analysis will examine the relationship between symptom recovery time and the Functional Status Scale of the Boston Carpal Tunnel Questionnaire. Electrodiagnostic severity, symptom onset latency during the Phalen test, and study center will be considered in the adjusted analysis. Secondary analyses will examine the relationships of recovery time with symptom severity, nighttime complaints, and electrodiagnostic findings.
To evaluate test-retest reliability, a subgroup of participants with a positive Phalen test will repeat the same procedure after 3-7 days using the same hand, evaluator, and standardized test method. This study is observational, and no treatment or therapeutic intervention will be assigned.
605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.
This study's planned enrollment of 200 is above the median of 91 across 130 observational studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Mardin Artuklu University is the lead sponsor of 32 studies on the registry; 13 are open to participants now.
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Adults presenting to the physical medicine and rehabilitation clinics of the participating centers with clinical symptoms consistent with carpal tunnel syndrome and confirmation by nerve conduction studies will be screened. Eligible participants who provide written informed consent will be enrolled consecutively. For bilateral carpal tunnel syndrome, the hand with greater nighttime paresthesia will be evaluated; if symptom severity is equal, the dominant hand will be selected.
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Exclusion Criteria:
Adults with clinical symptoms of carpal tunnel syndrome confirmed by nerve conduction studies. Participants will undergo the standardized timed Phalen test and clinical assessments. No therapeutic intervention will be assigned.
Diagnostic Test: Timed Phalen Test
Participants will sit with the backs of both hands placed together and the wrists held in full flexion without external pressure. The test will continue for up to 60 seconds and will be stopped when typical symptoms in the median nerve distribution newly appear or clearly increase. Symptom onset latency will be recorded in seconds. After the wrists are returned to a neutral position, the time required for symptoms to return to their pre-test level will be recorded for up to 300 seconds. This diagnostic test is performed for assessment purposes and does not involve treatment.
Symptom Recovery Time After the Phalen Test
For participants with a positive Phalen test, symptom recovery time will be measured in seconds from the moment the wrists are returned to a neutral position until the provoked symptoms return to their pre-test level. The minimum value is 0 seconds. Recovery will be observed for up to 300 seconds. Participants whose symptoms do not return to baseline within this period will be recorded as having a recovery time exceeding 300 seconds; 300 seconds will be used in the primary analysis, with a sensitivity analysis excluding these observations. Higher values indicate slower symptom recovery. The relationship between recovery time and the Boston Carpal Tunnel Questionnaire Functional Status Scale will be evaluated, with adjustment for electrodiagnostic severity, symptom onset latency, and study center.
Time frame: Baseline
Boston Carpal Tunnel Questionnaire Functional Status Scale Score
Hand function will be assessed using the eight-item Functional Status Scale of the Boston Carpal Tunnel Questionnaire. Each item is scored from 1 to 5, and the final score is the mean of the completed items. The total score ranges from 1 to 5, with higher scores indicating greater difficulty in hand-related activities and worse functional status.
Time frame: Baseline
Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score
Symptom severity will be assessed using the 11-item Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire. Each item is scored from 1 to 5, and the final score is the mean of the completed items. The total score ranges from 1 to 5, with higher scores indicating more severe carpal tunnel syndrome symptoms.
Time frame: Baseline
Symptom Onset Latency During the Phalen Test
The time from the beginning of the Phalen test until typical symptoms in the median nerve distribution newly appear or clearly increase will be recorded in seconds. Values range from 0 to 60 seconds. Higher values indicate a longer time before symptom onset and do not necessarily represent a better or worse clinical outcome. Participants without typical symptoms within 60 seconds will be classified as having a negative Phalen test.
Time frame: Baseline
Carpal Tunnel Syndrome-Related Nighttime Awakenings
Participants will report the total number of awakenings caused by carpal tunnel syndrome symptoms during the previous seven nights. The minimum value is 0 and there is no predefined maximum. Higher values indicate more frequent sleep disruption.
Time frame: Baseline
Nighttime Numbness or Tingling Intensity
Nighttime numbness or tingling in the evaluated hand will be rated using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no numbness or tingling and 10 indicates the worst imaginable numbness or tingling. Higher scores indicate greater symptom intensity.
Time frame: Baseline
Duration of Morning Numbness
The duration of numbness in the evaluated hand after waking in the morning will be reported in minutes. The minimum value is 0 minutes and there is no predefined maximum. Higher values indicate longer-lasting morning numbness.
Time frame: Baseline
Test-Retest Reliability of the Timed Phalen Test
A subgroup of participants with a positive Phalen test will repeat the standardized test after 3-7 days. The reliability of symptom recovery time will be evaluated using the intraclass correlation coefficient among participants with a positive test at both assessments. Agreement in Phalen test positivity will be evaluated using Cohen's kappa coefficient. Higher coefficient values indicate greater test-retest reliability or agreement.
Time frame: Baseline and 3-7 days after baseline
Plan to share: No
Start is estimated for Dec 2026; primary completion for Aug 2027, 8 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Mardin Artuklu University