Changes in Sleep, Fatigue, Kinesiophobia, and Upper Extremity Function After Carpal Tunnel Release (CTS-RECOVER)

September 2, 2026 updated by: salih tan, Istanbul Medipol University Hospital

Prospective Longitudinal Evaluation of Changes in Sleep Quality, Fatigue, Kinesiophobia, Pain, and Upper Extremity Function After Carpal Tunnel Release Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

  1. Pittsburgh Sleep Quality Index to assess sleep quality.
  2. Fatigue Severity Scale to assess the severity and functional impact of fatigue.
  3. Tampa Scale of Kinesiophobia to assess fear of movement or reinjury.
  4. QuickDASH to assess symptoms and upper extremity functional limitations.
  5. Boston Carpal Tunnel Questionnaire, including the Symptom Severity Scale and Functional Status Scale, to assess carpal tunnel syndrome-specific outcomes.
  6. Numeric Rating Scale to assess pain at rest, during activity, and at night.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Adults aged 18 to 70 years.
  • Clinical and electrophysiological diagnosis of carpal tunnel syndrome.
  • Scheduled to undergo unilateral primary carpal tunnel release surgery as part of routine clinical care.
  • Ability to read and understand Turkish.
  • Sufficient cognitive ability to understand and complete the study questionnaires.
  • Willingness to participate and provision of written informed consent.
  • Ability and willingness to complete the preoperative and postoperative follow-up assessments.

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:

  • Previous carpal tunnel release surgery on the index hand.
  • Scheduled revision carpal tunnel surgery.
  • Simultaneous bilateral carpal tunnel release surgery.
  • Concomitant severe cervical radiculopathy, brachial plexus lesion, ulnar neuropathy, radial neuropathy, or another neurological or orthopedic condition that substantially affects upper extremity function.
  • Severe rheumatologic or neurodegenerative disease affecting upper extremity function.
  • Cognitive impairment or severe psychiatric illness that prevents understanding or completion of the study assessments.
  • Uncontrolled systemic disease that may interfere with participation or follow-up.
  • New trauma or additional surgery affecting the same upper extremity during the follow-up period.
  • Inability to complete the planned follow-up assessments.
  • Refusal or withdrawal of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Carpal Tunnel Release Cohort
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index Total Score
Time Frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
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.
Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Fatigue Severity Scale Score
Time Frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
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.
Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in Tampa Scale of Kinesiophobia Score
Time Frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
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.
Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
Change in QuickDASH Score
Time Frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
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.
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
Time Frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
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.
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
Time Frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
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.
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
Time Frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
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.
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
Time Frame: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)
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.
Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTS-PROSPECT-2026-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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