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

NCT07806071 | Not Yet Recruiting

• 1 other identifier: CTS-PROSPECT-2026-02
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Release; Sleep Quality; Kinesiophobia; Fatigue; QuickDASH

Outcome Measures

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.

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

Secondary Outcomes (7)

• Change in Fatigue Severity Scale Score

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

• Change in Tampa Scale of Kinesiophobia Score

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

• Change in QuickDASH Score

  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

  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

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

Study Arms (1)

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

Interventions

Carpal Tunnel Release Surgery PROCEDURE

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.

Carpal Tunnel Release Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Sleep Initiation and Maintenance Disorders; Kinesiophobia; Fatigue

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Phobic Disorders; Anxiety Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

MEHMET SALİH TAN, PhD, PT

CONTACT

+90 546 726 6876; mstan@medipol.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share