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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorIstanbul Medipol University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Carpal Tunnel Release Surgery

    Procedure/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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Carpal Tunnel Release Cohort1 intervention

Trial outcomes

Primary outcomes

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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Istanbul Medipol University Hospital

Lead sponsor

Medipol University

Sponsor institution

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