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

2. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

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Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Pittsburgh Sleep Quality Index Total Score
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Fatigue Severity Scale Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

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Sponsor

Istanbul Medipol University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

2. september 2026

Først innsendt som oppfylte QC-kriteriene

2. september 2026

Først lagt ut (Faktiske)

8. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CTS-PROSPECT-2026-02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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