Carpal Tunnel SyndromeNCT05047367
The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome and Depressive Symptoms, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Depressive Symptoms, Sleepiness
- What is being tested?
- cross-sectional survey study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 149 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2021to 20 Jul 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with CTS
Who may be able to join
- Patients aged 18-75 years diagnosed with CTS.
- Patients who were mentally able to respond to the assessment questionnaires were also included
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome, Depressive Symptoms, Sleepiness, Anxiety, Sleep, Pain, Neuropathic
- Being tested
- cross-sectional survey study
- Keywords
- CTS,Psychological factors,Sleep quality,Daytime Sleepiness
- Medical subject headings
- Carpal Tunnel Syndrome, Depression, Sleepiness, Anxiety Disorders, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectional survey studyBehavioural
Also called all patients were filled out forms for sleep quality and psychological evaluation
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
| Study group | Role | What they receive |
|---|---|---|
| single-group studies | A total of 149 patients diagnosed with CTS, 126 female and 23 male, were included in the study Receives: Behavioral: cross-sectional survey study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Carpal Tunnel Syndrome
Electromyography evaluation of patients
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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"
Measured: 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.
Measured: study completion,an average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start13 Jan 2021
- Primary completion19 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Güler, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047367
- Sponsor's protocol ID
- 2021-01/39
- Status last verified
- Sep 2021
- First submitted
- 6 Aug 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the importance of the data obtained in the study will be shared after
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.
PubMed 31319726
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05047367
- Acronym / sponsor ID
- 2021-01/39
- Conditions
- Carpal Tunnel Syndrome, Depressive Symptoms, Sleepiness, Anxiety, Sleep, Pain, Neuropathic
- Keywords
- CTS,Psychological factors,Sleep quality,Daytime Sleepiness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-group studies | – | Behavioral: cross-sectional survey studyA total of 149 patients diagnosed with CTS, 126 female and 23 male, were included in the study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with CTS
Key inclusion criteria (2 listed)
- Patients aged 18-75 years diagnosed with CTS.
- Patients who were mentally able to respond to the assessment questionnaires were also included
Key exclusion criteria (8 listed)
- Clinical diagnosis of cervical radiculopathy/plexopathy findings
- Pregnancy
- Diabetes mellitus
- thyroid diseases
- amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cross-sectional survey studyAlso: all patients were filled out forms for sleep quality and psychological evaluationBeck 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 | Behavioural | single-group studies |
Primary outcome
Severity of Carpal Tunnel Syndrome
Time frame: study completion,an average of six months
Electromyography evaluation of patients
The correlation between severity of Carpal Tunnel Syndrome and psychological evaluation
Time frame: study completion,an average of six months
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.
The correlation between severity of Carpal Tunnel Syndrome and pain intensity
Time frame: study completion,an average of six months
Visual Analog Scale will be used for pain intensity.It is scored between 0-10. =: no pain 10: defined as the most severe pain
The correlation between severity of Carpal Tunnel Syndrome and neuropathic pain
Time frame: study completion,an average of six months
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.
The correlation between severity of Carpal Tunnel Syndrome and sleep quality
Time frame: study completion,an average of six months
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"
The correlation between severity of Carpal Tunnel Syndrome and sleepiness
Time frame: study completion,an average of six months
Epworth Sleepiness Scale will be used for sleepiness. It is scored between 0-28. As the total score increases, sleepiness increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Results publication: PubMed 31319726Rubin 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.
- Individual participant dataSharing planned: Undecided. the importance of the data obtained in the study will be shared after
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome and Depressive Symptoms, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Carpal Tunnel Syndrome (time frame: study completion,an average of six months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.