Carpal Tunnel Syndrome (CTS)NCT07876765
Symptom Recovery Time After the Phalen Test in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS), run by Mardin Artuklu University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Timed Phalen Test
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Dec 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age between 18 and 75 years
- Clinical symptoms consistent with carpal tunnel syndrome
- Carpal tunnel syndrome confirmed by nerve conduction studies
- Ability to complete the Boston Carpal Tunnel Questionnaire and study assessments
- Provision of written informed consent
Who cannot join
- Polyneuropathy
- Clinical or electrodiagnostic evidence of cervical radiculopathy or brachial plexopathy
- Previous carpal tunnel surgery in the evaluated hand
- Local injection into the evaluated hand within the previous 3 months
- Another neurological or musculoskeletal disorder that substantially affects hand or upper-extremity function
- Inflammatory arthritis or severe rheumatologic disease affecting the wrist
Show all 10Show fewer
- Acute hand or wrist trauma
- Marked restriction of wrist range of motion preventing performance of the Phalen test
- Pregnancy, postpartum period, or breastfeeding
- Cognitive or communication problems preventing completion of the study assessments
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Bagcilar Training and Research Hospital
Istanbul, 34200
Fuat Orhun Alayoğlu, M.D., +90534 843 1984, f.orhunalayoglu@gmail.com
Mardin Training and Research Hospital
Mardin, 47100
Taha Yasin YILDIRIM, M.D., +90 534 220 77 17, tyasinyildirim.ftr@gmail.com
About this study
Official title: Clinical Significance of Symptom Recovery Time After the Phalen Test in Carpal Tunnel Syndrome
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.
Read the detailed description
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.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Timed Phalen Test
- Keywords
- Carpal Tunnel Syndrome, Phalen Test, Median Nerve, Boston Carpal Tunnel Questionnaire, Electrodiagnostic Severity
- 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.
Timed Phalen TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Electrodiagnostically Confirmed Carpal Tunnel Syndrome | 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. Receives: Diagnostic Test: Timed Phalen Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3-7 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Responsible party
- Principal investigator, Taha Yasin YILDIRIM, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876765
- Sponsor's protocol ID
- MEAH-PMR-TYY4
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacDermid JC, Doherty T. Clinical and electrodiagnostic testing of carpal tunnel syndrome: a narrative review. J Orthop Sports Phys Ther. 2004 Oct;34(10):565-88. doi: 10.2519/jospt.2004.34.10.565.
PubMed 15552704Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
PubMed 8245050Ghavanini MR, Haghighat M. Carpal tunnel syndrome: reappraisal of five clinical tests. Electromyogr Clin Neurophysiol. 1998 Oct-Nov;38(7):437-41.
PubMed 9809232
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Symptom Recovery Time After the Phalen Test in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07876765
- Acronym / sponsor ID
- MEAH-PMR-TYY4
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Carpal Tunnel Syndrome, Phalen Test, Median Nerve, Boston Carpal Tunnel Questionnaire, Electrodiagnostic Severity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Oct 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Electrodiagnostically Confirmed Carpal Tunnel Syndrome | – | Diagnostic Test: Timed Phalen TestAdults 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Age between 18 and 75 years
- Clinical symptoms consistent with carpal tunnel syndrome
- Carpal tunnel syndrome confirmed by nerve conduction studies
- Ability to complete the Boston Carpal Tunnel Questionnaire and study assessments
- Provision of written informed consent
Key exclusion criteria (10 listed)
- Polyneuropathy
- Clinical or electrodiagnostic evidence of cervical radiculopathy or brachial plexopathy
- Previous carpal tunnel surgery in the evaluated hand
- Local injection into the evaluated hand within the previous 3 months
- Another neurological or musculoskeletal disorder that substantially affects hand or upper-extremity function
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 |
|---|---|---|
| Timed Phalen TestParticipants 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. | Diagnostic test | Patients With Electrodiagnostically Confirmed Carpal Tunnel Syndrome |
Primary outcome
Symptom Recovery Time After the Phalen Test
Time frame: Baseline
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.
7 secondary outcomes
Boston Carpal Tunnel Questionnaire Functional Status Scale Score
Time frame: Baseline
Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score
Time frame: Baseline
Symptom Onset Latency During the Phalen Test
Time frame: Baseline
Carpal Tunnel Syndrome-Related Nighttime Awakenings
Time frame: Baseline
Nighttime Numbness or Tingling Intensity
Time frame: Baseline
Duration of Morning Numbness
Time frame: Baseline
Test-Retest Reliability of the Timed Phalen Test
Time frame: Baseline and 3-7 days after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 15552704MacDermid JC, Doherty T. Clinical and electrodiagnostic testing of carpal tunnel syndrome: a narrative review. J Orthop Sports Phys Ther. 2004 Oct;34(10):565-88. doi: 10.2519/jospt.2004.34.10.565.
- Background: PubMed 8245050Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
- Background: PubMed 9809232Ghavanini MR, Haghighat M. Carpal tunnel syndrome: reappraisal of five clinical tests. Electromyogr Clin Neurophysiol. 1998 Oct-Nov;38(7):437-41.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome (CTS), run by Mardin Artuklu University at 2 sites in Turkey (Türkiye).
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taha Yasin YILDIRIM, M.D. (+90 534 220 77 17, tyasinyildirim.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Recovery Time After the Phalen Test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07876765, which also lists 3 linked publications.
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 20 Oct 2026.