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Recruiting NCT05742776

The Relationship Between Ultrasonographic Findings and Sleep Quality in Carpal Tunnel Syndrome

— Observational Musculoskeletal Diseases Median Nerve Disease Carpal Tunnel Syndrome Ultrasound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of Sleep Quality, Assessment of Sleep Quality.
Who it may be relevant to
Registry conditions: Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome, Ultrasound. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Relationship Between Ultrasonographic Findings and Sleep Quality in Patients With Carpal Tunnel Syndrome

Overview

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients and to compare the findings with healthy controls.

Detailed description

Carpal tunnel syndrome is the most common form of entrapment neuropathies. Anatomically, the roof of the carpal tunnel consists of carpal bones, it is located under the transverse carpal ligament, and there are 9 tendon packs of the forearm flexors and the median nerve. Clinically, sensory (paresthesia and hypoesthesia), motor deficits and pain occur in the distribution of the median nerve secondary to mechanical compression and local ischemia.

With the increase in the severity of the disease, entrapment neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Waking up at night due to paresthesia is one of the diagnostic criteria for carpal tunnel syndrome. However, the mechanism linking CTS with insomnia is unclear.

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients.

Interventions

  • Other Assessment of Sleep Quality
    Assessment of Sleep Quality
  • Other Assessment of Sleep Quality
    Assessment of Sleep Quality

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: 2023.02-2023.05]
Secondary outcome measures (5)
  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) [Time frame: 2023.02-2023.05]
  • Cross-sectional area of the Median Nerve (CSA) [Time frame: 2023.02-2023.05]
  • Electrophysiological Evaluation [Time frame: 2023.02-2023.05]
  • Hand and Finger Grip Strength Assessment [Time frame: 2023.02-2023.05]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: 2023.02-2023.05]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with CTS according to the criteria of the American Academy of Neurology

Exclusion criteria

  • Patients with radiculopathy, brachial plexopathy, thoracic outlet syndrome and traumatic nerve injury that may affect the median nerve
  • History of Carpal tunnel surgery
  • Pregnancy
  • Malignancy
  • Thyroid diseases
  • Amyloidosis
  • Systemic lupus erythematosus, Rheumatoid arthritis, Systemic sclerosis, Gout, Dermatomyositis, Polymyositis
  • Obstructive sleep apnea

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Afyonkarahisar Health Sciences University — Afyonkarahisar

Publications

  • Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11. PMID 27751557
  • Okkesim CE, Serbest S, Tiftikci U, Cirpar M. Prospective evaluation of preoperative and postoperative sleep quality in carpal tunnel release. J Hand Surg Eur Vol. 2019 Mar;44(3):278-282. doi: 10.1177/1753193418808182. Epub 2018 Nov 4. PMID 30394830
  • Kaymak B, Ozcakar L, Cetin A, Candan Cetin M, Akinci A, Hascelik Z. A comparison of the benefits of sonography and electrophysiologic measurements as predictors of symptom severity and functional status in patients with carpal tunnel syndrome. Arch Phys Med Rehabil. 2008 Apr;89(4):743-8. doi: 10.1016/j.apmr.2007.09.041. PMID 18374007

Identifiers

NCT: NCT05742776 · CTSPUKI23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗