Clinical trial NCT05742776: The Relationship Between Ultrasonographic Findings and Sleep Quality in Carpal Tunnel Syndrome
Official title: The Relationship Between Ultrasonographic Findings and Sleep Quality in Patients With Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Diseases
Median Nerve Disease
Carpal Tunnel Syndrome
Ultrasound
Sleep Quality
Keywords: Carpal Tunnel Syndrome
Ultrasonographic evaluation
Pittsburgh Sleep Quality Index
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 90 patients with CTS and 30 patients with gonarthrosis as control group, aged between 20-80 years who applied to our clinic will be included in the study.

Brief summary: 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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 2023.02-2023.05
Secondary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
timeFrame: 2023.02-2023.05
measure: Cross-sectional area of the Median Nerve (CSA)
timeFrame: 2023.02-2023.05
measure: Electrophysiological Evaluation
timeFrame: 2023.02-2023.05
measure: Hand and Finger Grip Strength Assessment
timeFrame: 2023.02-2023.05
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2023.02-2023.05
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
state: Afyonkarahi̇sar
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Nuran EYVAZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Ali İzzet AKÇİN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.