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Carpal Tunnel Syndrome (CTS)CTS-RECOVERNCT07806071

Changes in Sleep, Fatigue, Kinesiophobia, and Upper Extremity Function After Carpal Tunnel Release

An observational study of Carpal Tunnel Syndrome (CTS), run by Istanbul Medipol University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
Carpal Tunnel Release Surgery
Type of treatment
Surgery or procedure
How many people
100 participants
Where
No sites listed yet
Study dates
Sep 2026to Nov 2026
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

MEHMET SALİH TAN, PhD, PT contact

+90 546 726 6876

mstan@medipol.edu.tr

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Carpal Tunnel Release Surgery
Keywords
Carpal Tunnel Release, Sleep Quality, Kinesiophobia, Fatigue, QuickDASH
Medical subject headings
Carpal Tunnel Syndrome, Sleep Initiation and Maintenance Disorders, Kinesiophobia, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carpal Tunnel Release SurgeryProcedure or 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.

Study groups in NCT07806071
Study groupRoleWhat they receive
Carpal Tunnel Release CohortAdults 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.
Receives: Procedure: Carpal Tunnel Release Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

Secondary outcomes (7)
  1. 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.

    Measured: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

  2. 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.

    Measured: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

  3. 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.

    Measured: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

  4. 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.

    Measured: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

  5. 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.

    Measured: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

  6. 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.

    Measured: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

  7. 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.

    Measured: Baseline (within 1 week before surgery), postoperative Week 4 (±7 days), and postoperative Week 8 (±7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07806071
Sponsor's protocol ID
CTS-PROSPECT-2026-02
Acronym
CTS-RECOVER
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS), run by Istanbul Medipol University Hospital.

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 8 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 MEHMET SALİH TAN, PhD, PT (+90 546 726 6876, mstan@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Sep 2026.

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