Carpal Tunnel SyndromeNCT05584839
Statistically Analysis of Carpal Tunnel Syndrome Diagnosis
An observational study of Carpal Tunnel Syndrome and Diagnosis, run by İSMAİL CEYLAN at 1 site in Turkey (Türkiye).
Trial summary
Trap neuropathies; They are compression neuropathies that occur as a result of peripheral nerves being compressed for various reasons along their anatomical paths. Although each nerve has areas suitable for anatomical entrapment, compression can occur at any point along the nerve. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carpal Tunnel Syndrome, Diagnosis
- What is being tested?
- Statistically Analysis
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Feb 2023
- How long will I take part?
- 2 Days
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Persons aged 18-65 years who apply to outpatient clinics with symptoms of CTS
Who may be able to join
- Admitted to outpatient clinics with symptoms of CTS
- Findings of CTS in physical examination
- CTS diagnosis was confirmed by nerve conduction study
- KTS grade mild or moderate
- He has not received physical therapy for this reason in the previous 1 year
- No steroid injection and no treatment for neuropathic pain (pregabalin, gabapentin, etc.)
Who cannot join
- - Those under the age of 18 Those with a history of previous surgery or fracture of the affected hand and wrist Those with diabetes mellitus, chronic kidney failure, gout, rheumatoid arthritis, thyroid diseases
- Pregnant Those with polyneuropathy, radiculopathy, plexopathy, thoracic outlet syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İsmail Ceylan
Kırşehir, Merkez, 40100
İsmail Ceylan, PhD, 05364634679 ext. +90, fztceylan@gmail.com
About this study
Official title: A Comprehensive Statistical Analysis for the Diagnosis of Carpal Tunnel Syndrome
Trap neuropathies; They are compression neuropathies that occur as a result of peripheral nerves being compressed for various reasons along their anatomical paths. Although each nerve has areas suitable for anatomical entrapment, compression can occur at any point along the nerve. Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy caused by compression of the median nerve at the wrist level. Its prevalence in the general population is 2.5-11%.
Although the majority of cases are idiopathic, it may also occur secondary to pathologies such as pregnancy, diabetes mellitus, thyroid dysfunction, arthritis, wrist fractures and acromegaly or occupation. The diagnosis of CTS is made clinically, but the best method for definitive diagnosis is electrophysiological examination.
Some anthropometric measurements that may be associated with CTS were made and their effect on the risk of CTS was investigated. In a study conducted by Sabry et al. in 2009, it was reported that there may be a relationship between BMI, wrist ratio (ratio of wrist depth to width) and wrist-palm ratio (ratio of wrist depth to palm length) and CTS risk. In a study by Lim et al. in 2008, it was reported that the critical value for wrist ratio was 0.70 and above. However, there were no studies reporting how many percent predictors of anthropometric measurements according to the severity of CTS.
Read the detailed description
The study was planned as a quantitative research. Socio-demographic information form, anthropometric measurements of hand grip strength, palm length, hand width length, wrist circumference length, Visual Analog Scale scale, EMG findings will be evaluated by hand dynamometer.
Trybus et al. Considering the study they conducted in patients with CTS in which they examined hand anthropometric measurements in CTS, it was planned to include 100 patients in the study with a power range of 80% and an effect width of 0.05.
- Conditions
- Carpal Tunnel Syndrome, Diagnosis
- Being tested
- Statistically Analysis
- Keywords
- carpal tunnell syndrome, anthpometric
- Medical subject headings
- Carpal Tunnel Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statistically AnalysisOther
The study was planned as a quantitative research. Socio-demographic information form, anthropometric measurements of hand grip strength, palm length, hand width length, wrist circumference length, Visual Analog Scale scale, EMG findings will be evaluated by hand dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| carpal tunnel syndrome | * Admitted to outpatient clinics with symptoms of CTS
* Findings of CTS in physical examination
* CTS diagnosis was confirmed by nerve conduction study
* KTS grade mild or moderate
* He has not received physical therapy for this reason in the previous 1 year
* No steroid injection and no treatment for neuropathic pain (pregabalin, gabapentin, etc.) Receives: Other: Statistically Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Strength
The grip strength of the dominant hand is measured using a standard adjustable digital grip dynamometer (Baseline Digital Smedley Hand Dynamometer). Handgrip strength is measured as follows: (a) Each subject is tested while sitting comfortably in a chair without armrests, with their back against the chair; (b) Each subject is instructed to sit with hips and knees flexed 90°, shoulders adducted and neutrally rotated, elbows flexed 90°, forearm rotation 0°, wrists dorsiflexed 0° to 30°, and ulnar deviation 0° to 15°; and asked to squeeze the dynamometer.
Measured: 0-1 days
Secondary outcomes (1)
Hand length
Hand length is moderate when forearm and hand are brought to supination on a table.
is the distance from the tip of the finger to the midline of the distal wrist crease.
Measured: 0-1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- İSMAİL CEYLAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İSMAİL CEYLAN, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584839
- Sponsor's protocol ID
- 12068451745
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendin F. Effectiveness of mobilisation of the upper cervical region and craniocervical flexor training on orofacial pain, mandibular function and headache in women with TMD. A randomised, controlled trial. J Oral Rehabil. 2019 Feb;46(2):109-119. doi: 10.1111/joor.12733. Epub 2018 Oct 26.
PubMed 30307636
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Statistical Analysis for the Diagnosis of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05584839
- Acronym / sponsor ID
- 12068451745
- Conditions
- Carpal Tunnel Syndrome, Diagnosis
- Keywords
- carpal tunnell syndrome, anthpometric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- İSMAİL CEYLANUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 18 Oct 2022 (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.
Trap neuropathies; They are compression neuropathies that occur as a result of peripheral nerves being compressed for various reasons along their anatomical paths. Although each nerve has areas suitable for anatomical entrapment, compression can occur at any point along the nerve. Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy caused by compression of the median nerve at the wrist level. Its prevalence in the general population is 2.5-11%.
Although the majority of cases are idiopathic, it may also occur secondary to pathologies such as pregnancy, diabetes mellitus, thyroid dysfunction, arthritis, wrist fractures and acromegaly or occupation. The diagnosis of CTS is made clinically, but the best method for definitive diagnosis is electrophysiological examination.
Some anthropometric measurements that may be associated with CTS were made and their effect on the risk of CTS was investigated. In a study conducted by Sabry et al. in 2009, it was reported that there may be a relationship between BMI, wrist ratio (ratio of wrist depth to width) and wrist-palm ratio (ratio of wrist depth to palm length) and CTS risk. In a study by Lim et al. in 2008, it was reported that the critical value for wrist ratio was 0.70 and above. However, there were no studies reporting how many percent predictors of anthropometric measurements according to the severity of CTS.
Detailed description
The study was planned as a quantitative research. Socio-demographic information form, anthropometric measurements of hand grip strength, palm length, hand width length, wrist circumference length, Visual Analog Scale scale, EMG findings will be evaluated by hand dynamometer.
Trybus et al. Considering the study they conducted in patients with CTS in which they examined hand anthropometric measurements in CTS, it was planned to include 100 patients in the study with a power range of 80% and an effect width of 0.05.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carpal tunnel syndrome | – | Other: Statistically Analysis* Admitted to outpatient clinics with symptoms of CTS * Findings of CTS in physical examination * CTS diagnosis was confirmed by nerve conduction study * KTS grade mild or moderate * He has not received physical therapy for this reason in the previous 1 year * No steroid injection and no treatment for neuropathic pain (pregabalin, gabapentin, etc.) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Persons aged 18-65 years who apply to outpatient clinics with symptoms of CTS
Key inclusion criteria (6 listed)
- Admitted to outpatient clinics with symptoms of CTS
- Findings of CTS in physical examination
- CTS diagnosis was confirmed by nerve conduction study
- KTS grade mild or moderate
- He has not received physical therapy for this reason in the previous 1 year
Key exclusion criteria (2 listed)
- - Those under the age of 18 Those with a history of previous surgery or fracture of the affected hand and wrist Those with diabetes mellitus, chronic kidney failure, gout, rheumatoid arthritis, thyroid diseases
- Pregnant Those with polyneuropathy, radiculopathy, plexopathy, thoracic outlet syndrome
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 |
|---|---|---|
| Statistically AnalysisThe study was planned as a quantitative research. Socio-demographic information form, anthropometric measurements of hand grip strength, palm length, hand width length, wrist circumference length, Visual Analog Scale scale, EMG findings will be evaluated by hand dynamometer. | Other | carpal tunnel syndrome |
Primary outcome
Hand Grip Strength
Time frame: 0-1 days
The grip strength of the dominant hand is measured using a standard adjustable digital grip dynamometer (Baseline Digital Smedley Hand Dynamometer). Handgrip strength is measured as follows: (a) Each subject is tested while sitting comfortably in a chair without armrests, with their back against the chair; (b) Each subject is instructed to sit with hips and knees flexed 90°, shoulders adducted and neutrally rotated, elbows flexed 90°, forearm rotation 0°, wrists dorsiflexed 0° to 30°, and ulnar deviation 0° to 15°; and asked to squeeze the dynamometer.
1 secondary outcome
Hand length
Time frame: 0-1 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Background: PubMed 30307636Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendin F. Effectiveness of mobilisation of the upper cervical region and craniocervical flexor training on orofacial pain, mandibular function and headache in women with TMD. A randomised, controlled trial. J Oral Rehabil. 2019 Feb;46(2):109-119. doi: 10.1111/joor.12733. Epub 2018 Oct 26.
- Individual participant dataSharing planned: Undecided
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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.
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 Diagnosis, run by İSMAİL CEYLAN 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İsmail Ceylan, PhD. (05364634679 ext. +90, fztceylan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Grip Strength (time frame: 0-1 days). 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 NCT05584839, 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 18 Oct 2022.