The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome

Anxiety Clinical Trial

Official title:

The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047367
• Other study ID #: 2021-01/39
• Status: Completed
• Start date: January 13, 2021
• Est. completion date: July 20, 2021

Study information

• Verified date: September 2021
• Source: Sivas Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The most common entrapment neuropathy symptoms, the diagnosis of CTS, is determined by examination findings and by means of the results of electro-diagnostic test. With an increase in disease severity, trap neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness.

Description:

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy with an incidence of 2.7-4%. CTS, resulting from compression of the median nerve in the wrist, clinically progresses with tingling, numbness matching the nerve trace, and motor deficit in the presence of progressive nerve damage. Accordingly, the incidence of neuropathic pain is increasing. In addition to these symptoms mentioned, electro-diagnostic tests are used for diagnostic purposes and to determine the severity of nerve compression, and as a result, there are different types of classification, but most commonly CTS is classified as mild, moderate and severe. This classification is of great importance for the regulation of the follow-up and treatment protocol and making the association of existing complaints with the disease. Studies have shown that approximately 80% of CTS patients wake up at night due to numbness in the hand, resulting in deterioration in sleep quality. Impairment of sleep quality may cause increased sympathetic nervous system activity and awakening of physical and psychological stressors. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness. This study;149 patients with a diagnosis of CTS were prospectively included in the study. Electro-diagnostic test results were used to determine the severity of the disease. In this context, Boston CTS rating scale was used to evaluate the functional and symptomatic effects, Pittsburgh sleep quality scale and Epworth sleepiness scale were used to evaluate sleep quality and daytime sleepiness, and pain DETECT questionnaire was used to evaluate pain type.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: July 20, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-75 years diagnosed with CTS.

• Patients who were mentally able to respond to the assessment questionnaires were also included

Exclusion Criteria:

• Clinical diagnosis of cervical radiculopathy/plexopathy findings

• Pregnancy

• Diabetes mellitus

• thyroid diseases

• amyloidosis

• collagen tissue diseases

• Obstructive sleep apnea

• History of the upper extremity trauma

Related Conditions & MeSH terms

• Anxiety
• Carpal Tunnel Syndrome
• Depression
• Depressive Symptoms
• Neuralgia
• Pain, Neuropathic
• Sleep
• Sleepiness
• Syndrome

Intervention

Behavioral:
• cross-sectional survey study
Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, Visual Analogue Scale and PainDETECT Questionnaire for pain, Pittsburgh Sleep Quality Scale and Epworth Sleepiness Scale for sleep quality

Locations

Country	Name	City	State
Turkey	Emel Guler	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Sivas Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Rubin G, Orbach H, Rinott M, Rozen N. Relationship between electrodiagnostic findings and sleep disturbance in carpal tunnel syndrome: A controlled objective and subjective study. J Int Med Res. 2020 Feb;48(2):300060519862673. doi: 10.1177/030006051986267 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Carpal Tunnel Syndrome	Electromyography evaluation of patients	study completion,an average of six months
Primary	The correlation between severity of Carpal Tunnel Syndrome and psychological evaluation	Beck Depression Scale, Beck Anxiety Scale will be used for psychological evaluation. =9 points are classified as normal,10-16 points as mild depression,17-29 points as moderate depression, and 30-63 points as severe depression.Beck Anxiety Scale will be used in anxiety interrogation. =9 points are classified as normal, 10-18 points as mild anxiety, 19-29 points as moderate anxiety, and 30-63 points as severe anxiety.	study completion,an average of six months
Primary	The correlation between severity of Carpal Tunnel Syndrome and pain intensity	Visual Analog Scale will be used for pain intensity.It is scored between 0-10. =: no pain 10: defined as the most severe pain	study completion,an average of six months
Primary	The correlation between severity of Carpal Tunnel Syndrome and neuropathic pain	PainDETECT Questionnaire will be used for neuropathic pain evaluation.The questionnaire score ranges from 0-35 points, and a score of 19 and above indicates the presence of neuropathic pain.	study completion,an average of six months
Primary	The correlation between severity of Carpal Tunnel Syndrome and sleep quality	Pittsburgh Sleep Quality Scale will be used for sleep quality. Those who score ?5 have poor sleep quality, and those who score =5 have "good sleep quality"	study completion,an average of six months
Primary	The correlation between severity of Carpal Tunnel Syndrome and sleepiness	Epworth Sleepiness Scale will be used for sleepiness. It is scored between 0-28. As the total score increases, sleepiness increases.	study completion,an average of six months