Musculoskeletal DiseasesNCT05742776
The Relationship Between Ultrasonographic Findings and Sleep Quality in Carpal Tunnel Syndrome
An observational study of Musculoskeletal Diseases and Median Nerve Disease, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome
- What is being tested?
- Assessment of Sleep Quality
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2023to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with CTS according to the criteria of the American Academy of Neurology
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar, Afyonkarahi̇sar, 03200
Ali İzzet AKÇİN, MD, +905469347374, dr.akcin93@gmail.com
Nuran EYVAZ, MD, +905334262442, n_eyvaz@hotmail.com
About this study
Official title: The Relationship Between Ultrasonographic Findings and Sleep Quality in Patients With Carpal Tunnel Syndrome
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.
Read the 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.
- Conditions
- Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome, Ultrasound, Sleep Quality
- Being tested
- Assessment of Sleep Quality
- Keywords
- Carpal Tunnel Syndrome, Ultrasonographic evaluation, Pittsburgh Sleep Quality Index
- Medical subject headings
- Musculoskeletal Diseases, Median Neuropathy, Carpal Tunnel Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Sleep QualityOther
Assessment of Sleep Quality
Assessment of Sleep QualityOther
Assessment of Sleep Quality
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | CTS Patients Receives: Other: Assessment of Sleep Quality | |
| Control Group | Healthy Individuals Receives: Other: Assessment of Sleep Quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
Measured: 2023.02-2023.05
Secondary outcomes (5)
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a frequently used questionnaire for CTS that includes 2 components. It evaluates for grading under two sub-headings: symptom severity scale (11 questions) and functional status scale (8 questions). Scores range from 0 to 5 for each question; 0 represents no difficulty during the activity, 5 represents extremely severe dysfunction.
Measured: 2023.02-2023.05
Cross-sectional area of the Median Nerve (CSA)
The cross-sectional area (CSA) of the median nerve will be used for analysis by the mean value of 3 measurements made with an electronic caliper at scaphoid-pisiform level. Ultrasonographic evaluations were planned to be performed with the 10-18-MHz linear probe of the MyLab 70 (Esaote, Genova, Italy) device by a physician experienced in US.
CSA values increase as clinical findings worsen.
Measured: 2023.02-2023.05
Electrophysiological Evaluation
The patients will be evaluated as mild-moderate-severe CTS according to the criteria of the American Academy of Neurology.
Measured: 2023.02-2023.05
Hand and Finger Grip Strength Assessment
The hand grip strength of the participants will be measured with the "Jamar Hand Dynamometer". Measurements will be made with the shoulder in adduction and neutral rotation adjacent to the trunk, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumb up. Finger grip strength will be evaluated with the "Jamar Digital Pinchmeter". Patients will be placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength.
Measured: 2023.02-2023.05
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that assesses sleep patterns and sleep quality in adults. The measure consists subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping pills, and daytime dysfunction in the past month. The global score of PUKI and each sub-parameter will be calculated and recorded separately. According to the PSQI, "good sleepers" are defined as a PSQI score = <5 and "bad sleepers" as PSQI > 5.
Measured: 2023.02-2023.05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start23 Feb 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuran Eyvaz, Afyonkarahisar Health Sciences University
- Investigators
- Nuran EYVAZ, MD, Principal investigator, Afyonkarahisar Health Sciences UniversityAli İzzet AKÇİN, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742776
- Sponsor's protocol ID
- CTSPUKI23
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27751557Okkesim 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.
PubMed 30394830Kaymak 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.
PubMed 18374007
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Ultrasonographic Findings and Sleep Quality in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05742776
- Acronym / sponsor ID
- CTSPUKI23
- Conditions
- Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome, Ultrasound, Sleep Quality
- Keywords
- Carpal Tunnel Syndrome, Ultrasonographic evaluation, Pittsburgh Sleep Quality Index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 24 Feb 2023 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Other: Assessment of Sleep QualityCTS Patients |
| Control Group | – | Other: Assessment of Sleep QualityHealthy Individuals |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with CTS according to the criteria of the American Academy of Neurology
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Assessment of Sleep QualityAssessment of Sleep Quality | Other | Patient Group |
| Assessment of Sleep QualityAssessment of Sleep Quality | Other | Control Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 2023.02-2023.05
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 27751557Padua 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.
- Background: PubMed 30394830Okkesim 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.
- Background: PubMed 18374007Kaymak 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.
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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.
Nuran EYVAZ, MD principal investigator
Afyonkarahisar Health Sciences University
Ali İzzet AKÇİN, MD principal investigator
Afyonkarahisar Health Sciences University
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 Musculoskeletal Diseases and Median Nerve Disease, run by Afyonkarahisar Health Sciences 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 1 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali İzzet AKÇİN, MD (+905469347374, dr.akcin93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 2023.02-2023.05). 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 NCT05742776, which also lists 3 linked publications.
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 9 Mar 2026.