An observational study in Carpal Tunnel Syndrome (CTS), sponsored by Istanbul Medipol University Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Istanbul Medipol University Hospital · Observational
Carpal tunnel syndrome can cause hand pain, numbness, weakness, sleep disturbance, fatigue, fear of movement, and difficulty performing daily activities. Carpal tunnel release surgery is commonly performed when symptoms are severe or do not improve with conservative treatment. However, recovery after surgery may involve changes not only in hand symptoms but also in sleep, fatigue, fear of movement, pain, and upper extremity function.
The aim of this prospective observational study is to evaluate how sleep quality, fatigue, kinesiophobia, pain, carpal tunnel syndrome-related symptoms, and upper extremity function change after carpal tunnel release surgery.
Adults scheduled for unilateral primary carpal tunnel release surgery as part of their routine clinical care will be invited to participate. The researchers will not assign or modify the surgical procedure, medication, rehabilitation, or other clinical treatment. Participants will be evaluated before surgery and at 4 and 8 weeks after surgery.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Fatigue, kinesiophobia, upper extremity function, carpal tunnel syndrome-related symptoms, and pain will be assessed using the Fatigue Severity Scale, Tampa Scale of Kinesiophobia, QuickDASH, Boston Carpal Tunnel Questionnaire, and Numeric Rating Scale, respectively.
The study will examine changes in these outcomes over time and investigate whether improvements in sleep and fatigue are associated with reductions in pain, kinesiophobia, and carpal tunnel syndrome symptoms and with improvements in upper extremity function.
Carpal tunnel syndrome is a common peripheral entrapment neuropathy caused by compression of the median nerve at the wrist. It may lead to pain, numbness, paresthesia, hand weakness, sleep disturbance, and limitations in upper extremity function. Night-time symptoms are particularly common and may cause frequent awakenings and impaired sleep quality. Patients may also experience fatigue and fear of movement, which can negatively affect the use of the operated hand and participation in daily activities.
Carpal tunnel release surgery is routinely performed in patients with severe median nerve compression or persistent symptoms despite conservative treatment. Although surgical outcomes are commonly evaluated using pain, sensory symptoms, nerve conduction findings, and hand function, these measures may not fully reflect the broader patient-centered recovery process. A longitudinal assessment of sleep quality, fatigue, kinesiophobia, pain, disease-specific symptoms, and upper extremity function may provide a more comprehensive understanding of recovery after surgery.
This study is designed as a prospective, observational, longitudinal cohort study. Adults diagnosed with carpal tunnel syndrome through clinical and electrophysiological evaluation and scheduled for unilateral primary carpal tunnel release surgery will be recruited consecutively from Medipol Hospitals in Istanbul, Türkiye.
The decision to perform surgery and the choice of surgical technique will be made by the treating physician as part of routine clinical care and independently of study participation. The investigators will not assign, modify, or restrict the surgical procedure, medication, postoperative rehabilitation, physiotherapy, or other clinical treatments. Therefore, the study does not include an experimental intervention.
Participants will be evaluated at three time points:
T0: Within 1 week before carpal tunnel release surgery.
T1: Postoperative Week 4, with an allowable window of plus or minus 7 days.
T2: Postoperative Week 8, with an allowable window of plus or minus 7 days.
At each assessment, the following patient-reported outcome measures will be administered:
Demographic and clinical information will include age, sex, body mass index, educational and occupational status, hand dominance, operated side, symptom duration, unilateral or bilateral carpal tunnel syndrome, electrophysiological severity, previous conservative treatments, comorbidities, medication use, smoking status, surgical technique, postoperative complications, and postoperative physiotherapy or rehabilitation.
The primary objective is to determine the change in sleep quality from the preoperative assessment to 4 and 8 weeks after surgery. Secondary objectives are to evaluate changes in fatigue, kinesiophobia, pain, carpal tunnel syndrome-specific symptoms, and upper extremity function and to investigate the relationships among changes in these outcomes. The study will also explore demographic and clinical factors associated with postoperative functional improvement.
Repeated measurements will be evaluated using longitudinal statistical methods. Linear mixed-effects models are planned for the primary analyses, with time included as a fixed effect and participant included as a random effect. Associations among outcome measures will be examined using correlation analyses, and potential predictors of postoperative functional improvement may be evaluated using multivariable regression models. Effect estimates and 95% confidence intervals will be reported.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's planned enrollment of 100 is close to the median of 94 across 130 observational studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Istanbul Medipol University Hospital is the lead sponsor of 366 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adults with clinically and electrophysiologically confirmed carpal tunnel syndrome who are scheduled to undergo unilateral primary carpal tunnel release surgery as part of routine clinical care at Medipol Hospitals in Istanbul, Türkiye. Eligible patients will be invited to participate before surgery and will be followed prospectively at postoperative Weeks 4 and 8. The decision to perform surgery and the choice of surgical technique will be made by the treating physician independently of study participation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For participants with bilateral carpal tunnel syndrome, only the surgically treated hand will be designated as the index hand and included in the study assessments.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with clinically and electrophysiologically confirmed carpal tunnel syndrome who are scheduled to undergo unilateral primary carpal tunnel release surgery as part of routine clinical care. Participants will be evaluated within 1 week before surgery and at 4 and 8 weeks after surgery. The investigators will not assign or modify the surgical technique, medication, rehabilitation, or other clinical treatment.
Procedure: Carpal Tunnel Release Surgery
Participants will undergo unilateral primary carpal tunnel release surgery based on the clinical decision of their treating physician and independently of study participation. The surgical technique and routine postoperative management will not be assigned or modified by the investigators. The study will prospectively observe changes in sleep quality, fatigue, kinesiophobia, pain, carpal tunnel syndrome-related symptoms, and upper extremity function after surgery.
Change in Pittsburgh Sleep Quality Index Total Score
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI contains seven components and produces a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. A global score greater than 5 generally indicates poor sleep quality. Change in the PSQI global score from baseline to each postoperative assessment will be analyzed.
Time frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in Fatigue Severity Scale Score
Fatigue will be assessed using the nine-item Fatigue Severity Scale (FSS). Each item is scored from 1 to 7, and the mean score ranges from 1 to 7. Higher scores indicate greater fatigue severity and a greater impact of fatigue on daily functioning. Change from baseline to each postoperative assessment will be analyzed.
Time frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in Tampa Scale of Kinesiophobia Score
Fear of movement or reinjury will be assessed using the 17-item Tampa Scale of Kinesiophobia (TSK). The total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia. Change from baseline to each postoperative assessment will be analyzed.
Time frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in QuickDASH Score
Upper extremity symptoms and functional limitations will be assessed using the 11-item QuickDASH questionnaire. The total score ranges from 0 to 100. Higher scores indicate greater symptoms and more severe upper extremity functional limitation. Change from baseline to each postoperative assessment will be analyzed.
Time frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score
Carpal tunnel syndrome-related symptom severity will be assessed using the Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire. The score ranges from 1 to 5, with higher scores indicating more severe symptoms. Change from baseline to each postoperative assessment will be analyzed.
Time frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in Boston Carpal Tunnel Questionnaire Functional Status Scale Score
Carpal tunnel syndrome-specific functional status will be assessed using the Functional Status Scale of the Boston Carpal Tunnel Questionnaire. The score ranges from 1 to 5, with higher scores indicating greater functional difficulty. Change from baseline to each postoperative assessment will be analyzed.
Time frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in Numeric Rating Scale Score for Pain at Rest
Hand or wrist pain at rest will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. Change from baseline to each postoperative assessment will be analyzed.
Time frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in Numeric Rating Scale Score for Pain During Activity
Hand or wrist pain during activity will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. Change from baseline to each postoperative assessment will be analyzed.
Time frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be made publicly available because the informed consent form does not include specific permission for external data sharing and because of participant privacy and confidentiality considerations. Study findings will be reported in aggregate form in scientific publications and presentations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul Medipol University Hospital →