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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Sleep; Anxiety; Depressive Symptoms; Sleepiness; Pain, Neuropathic
• Intervention / Treatment: Behavioral: cross-sectional survey study

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• Turkey
  • Sivas, Turkey
    • Emel Guler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with CTS

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
single-group studies; A total of 149 patients diagnosed with CTS, 126 female and 23 male, were included in the study	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; Other Names: all patients were filled out forms for sleep quality and psychological evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Carpal Tunnel Syndrome	Electromyography evaluation of patients	study completion,an average of six months
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cumhuriyet University

Publications and helpful links

General Publications

• 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: 10.1177/0300060519862673. Epub 2019 Jul 18.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: CTS,Psychological factors,Sleep quality,Daytime Sleepiness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Depression; Syndrome; Carpal Tunnel Syndrome; Neuralgia; Sleepiness
• Other Study ID Numbers: 2021-01/39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: the importance of the data obtained in the study will be shared after

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No