Carpal Tunnel SyndromeNCT04967144
Carpal Tunnel Syndrome, Right/Left Judgement
An observational study of Carpal Tunnel Syndrome, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The discrimination of the right/left side of the body is related to the integrity of the motor and somatosensory areas at the cortical and subcortical levels. Although some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Nerve conduction study and Montreal Cognitive Assessment Test
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2021to 30 Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Carpal Tunnel Syndrome
Who may be able to join
- Participants with a duration of symptoms associated with unilateral CTS of at least 3 months
- Participants with clinically and nerve conduction study confirmed carpal tunnel syndrome
- All participants will be right-hand dominance and diagnosed with carpal tunnel syndrome on the same side
- Participants with MOCA score minimum 26.
Who cannot join
- Severe visual impairment that may prevent performing the test
- Polyneuropathy
- Cervical spine surgery history
- Presence of abnormal cervical spine, shoulder, and elbow joint examination findings
- Patients with any history of surgery for the upper extremity
- Congenital/Developmental upper extremity malformations
- Central nervous system disease
- Antihistaminic, gabapentinoids, antiepileptics, methylphenidate, modafinil, neuroleptics use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Izmir, Karabaglar
About this study
Official title: Right/Left Judgement in Carpal Tunnel Syndrome
The discrimination of the right/left side of the body is related to the integrity of the motor and somatosensory areas at the cortical and subcortical levels. Although some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies. In this study, the effect on right/left side discrimination will be investigated even in cases with carpal tunnel syndrome. Additionally, the investigators aimed to assess the relationship between right/left discrimination and symptom severity.
Read the detailed description
The left/right discrimination is a motor imagery task that involves viewing images of a body part and determining whether each image belongs to the left or right side of the body or if it rotates towards it. Some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies, such as carpal tunnel syndrome. In this study, the relationship between right/left decision accuracy will be compared with control subjects. The investigators will assess the relationship between right/left judgment and symptom severity, two-point discrimination, and handgrip force.
The hypothesis of the study are:
- The right/left discrimination accuracy is less than the control subjects.
- Right/left discrimination is in relationship with symptom severity, two-point discrimination, and handgrip force.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Nerve conduction study, Montreal Cognitive Assessment Test
- Keywords
- Carpal tunnel syndrome, body schema
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve conduction studyDiagnostic test
Participants with carpal tunnel syndrome will consist of individuals whose diagnosis has been confirmed by an electrophysiological study.
Participants in the control group will consist of those who have been confirmed not to have carpal tunnel syndrome by nerve conduction study.
Montreal Cognitive Assessment TestDiagnostic test
Montreal Cognitive Assessment Test evaluates eight separate cognitive functions. Thirty is the highest score. The scores equal to or above 26 are considered normal cognitive function.
| Study group | Role | What they receive |
|---|---|---|
| Carpal Tunnel syndrome | .Patients with carpal tunnel syndrome Receives: Diagnostic Test: Nerve conduction study; Diagnostic Test: Montreal Cognitive Assessment Test | |
| Control subjects | Healthy subjects Receives: Diagnostic Test: Nerve conduction study; Diagnostic Test: Montreal Cognitive Assessment Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left/right judgement Task
The Recognize tablet application will be used within the scope of the 'Graded Motor Imagery' set, in the series of publications created by www.noigroup.com right/left side judgement. The application will be performed on a single tablet screen. Within the scope of the application, right and left-hand pictures will be shown to the participants in varying positions and angles at 5-second intervals. The test consists of 50 pictures. At the end of the test, the accuracy rate and the average reaction time will be calculated separately for the right and left sides.
Measured: 3 months
Secondary outcomes (5)
Handgrip strength
The both handgrip strength of the participants will be evaluated with a JAMAR hand dynamometer.
Measured: 3 months
Two-point discrimination test
The participants will use a 2-point disc-criminator with 2-point separation and the narrowest interval reported by the participant as two separate points with repetitive measurements from the distal volar region of both index fingers will be recorded.
Measured: 3 months
Visual Analogue Scale
The patient will be asked to mark his/her severity of pain on a 10-cm horizontal line with number 0 one end representing 'no' and number 10 on the other end indicating 'very severe pain'.
Measured: 3 months
PainDETECT questionnaire
The presence of neuropathic pain will be evaluated with the painDETECT questionnaire. The maximum score is 35 and a high score indicates the severity of neuropathic pain. When the painDETECT questionnaire score is more than 13, it is indicated the presence of a neuropathic pain component.
Measured: 3 months
Boston Carpal Tunnel Questionnaire
The questionnaire comprises two parts, the Symptom Severity (SSS) and the Functional Status Scale (FSS). In the SSS, there are 11 questions; responses may be scored one (mildest) point to five (most severe) points. In the FSS, there are eight questions assessing the difficulty in performing selected activities.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start19 Jul 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeniz Akçay, Bozyaka Training and Research Hospital
- Investigators
- Seniz Akcay, Assoc Prof, Study director, University of Health Sciences Izmir Bozyaka Training and Research HospitalAltinay Goksel Karatepe, Prof, Study chair, University of Health Sciences Izmir Bozyaka Training and Research HospitalFikriye Elif Saka, MD, Study chair, University of Health Sciences Izmir Bozyaka Training and Research HospitalAsli Koskderelioglu, Assoc Prof, Study chair, University of Health Sciences Izmir Bozyaka Training and Research HospitalNeslihan Eskut, Specialist, Study chair, University of Health Sciences Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967144
- Sponsor's protocol ID
- 2021/40
- Status last verified
- Feb 2022
- First submitted
- 8 Jul 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The clinical study report will be shared at the end of the study.
Publications
Breckenridge JD, Ginn KA, Wallwork SB, McAuley JH. Do People With Chronic Musculoskeletal Pain Have Impaired Motor Imagery? A Meta-analytical Systematic Review of the Left/Right Judgment Task. J Pain. 2019 Feb;20(2):119-132. doi: 10.1016/j.jpain.2018.07.004. Epub 2018 Aug 9.
PubMed 30098404Schmid AB, Coppieters MW. Left/right judgment of body parts is selectively impaired in patients with unilateral carpal tunnel syndrome. Clin J Pain. 2012 Sep;28(7):615-22. doi: 10.1097/AJP.0b013e31823e16b9.
PubMed 22688599Moseley GL. Why do people with complex regional pain syndrome take longer to recognize their affected hand? Neurology. 2004 Jun 22;62(12):2182-6. doi: 10.1212/01.wnl.0000130156.05828.43.
PubMed 15210879Williams LJ, Braithwaite FA, Leake HB, McDonnell MN, Peto DK, Lorimer Moseley G, Hillier SL. Reliability and validity of a mobile tablet for assessing left/right judgements. Musculoskelet Sci Pract. 2019 Apr;40:45-52. doi: 10.1016/j.msksp.2019.01.010. Epub 2019 Jan 24.
PubMed 30703633Akcay S, Koskderelioglu A, Ince B, Elif Saka F, Eskut N, Goksel Karatepe A. Is the left/right judgment task performance altered in unilateral carpal tunnel syndrome: And associated with symptom severity? Musculoskelet Sci Pract. 2022 Dec;62:102641. doi: 10.1016/j.msksp.2022.102641. Epub 2022 Aug 4.
PubMed 35961062
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right/Left Judgement in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04967144
- Acronym / sponsor ID
- 2021/40
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, body schema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 Jul 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 discrimination of the right/left side of the body is related to the integrity of the motor and somatosensory areas at the cortical and subcortical levels. Although some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies. In this study, the effect on right/left side discrimination will be investigated even in cases with carpal tunnel syndrome. Additionally, the investigators aimed to assess the relationship between right/left discrimination and symptom severity.
Detailed description
The left/right discrimination is a motor imagery task that involves viewing images of a body part and determining whether each image belongs to the left or right side of the body or if it rotates towards it. Some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies, such as carpal tunnel syndrome. In this study, the relationship between right/left decision accuracy will be compared with control subjects. The investigators will assess the relationship between right/left judgment and symptom severity, two-point discrimination, and handgrip force.
The hypothesis of the study are:
- The right/left discrimination accuracy is less than the control subjects.
- Right/left discrimination is in relationship with symptom severity, two-point discrimination, and handgrip force.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel syndrome | – | Diagnostic Test: Nerve conduction study, Diagnostic Test: Montreal Cognitive Assessment Test.Patients with carpal tunnel syndrome |
| Control subjects | – | Diagnostic Test: Nerve conduction study, Diagnostic Test: Montreal Cognitive Assessment TestHealthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Carpal Tunnel Syndrome
Key inclusion criteria (4 listed)
- Participants with a duration of symptoms associated with unilateral CTS of at least 3 months
- Participants with clinically and nerve conduction study confirmed carpal tunnel syndrome
- All participants will be right-hand dominance and diagnosed with carpal tunnel syndrome on the same side
- Participants with MOCA score minimum 26.
Key exclusion criteria (8 listed)
- Severe visual impairment that may prevent performing the test
- Polyneuropathy
- Cervical spine surgery history
- Presence of abnormal cervical spine, shoulder, and elbow joint examination findings
- Patients with any history of surgery for the upper extremity
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 |
|---|---|---|
| Nerve conduction studyParticipants with carpal tunnel syndrome will consist of individuals whose diagnosis has been confirmed by an electrophysiological study. Participants in the control group will consist of those who have been confirmed not to have carpal tunnel syndrome by nerve conduction study. | Diagnostic test | Carpal Tunnel syndrome, Control subjects |
| Montreal Cognitive Assessment TestMontreal Cognitive Assessment Test evaluates eight separate cognitive functions. Thirty is the highest score. The scores equal to or above 26 are considered normal cognitive function. | Diagnostic test | Carpal Tunnel syndrome, Control subjects |
Primary outcome
Left/right judgement Task
Time frame: 3 months
The Recognize tablet application will be used within the scope of the 'Graded Motor Imagery' set, in the series of publications created by www.noigroup.com right/left side judgement. The application will be performed on a single tablet screen. Within the scope of the application, right and left-hand pictures will be shown to the participants in varying positions and angles at 5-second intervals. The test consists of 50 pictures. At the end of the test, the accuracy rate and the average reaction time will be calculated separately for the right and left sides.
5 secondary outcomes
Handgrip strength
Time frame: 3 months
Two-point discrimination test
Time frame: 3 months
Visual Analogue Scale
Time frame: 3 months
PainDETECT questionnaire
Time frame: 3 months
Boston Carpal Tunnel Questionnaire
Time frame: 3 months
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 22 Feb 2022.
- Background: PubMed 30098404Breckenridge JD, Ginn KA, Wallwork SB, McAuley JH. Do People With Chronic Musculoskeletal Pain Have Impaired Motor Imagery? A Meta-analytical Systematic Review of the Left/Right Judgment Task. J Pain. 2019 Feb;20(2):119-132. doi: 10.1016/j.jpain.2018.07.004. Epub 2018 Aug 9.
- Results publication: PubMed 22688599Schmid AB, Coppieters MW. Left/right judgment of body parts is selectively impaired in patients with unilateral carpal tunnel syndrome. Clin J Pain. 2012 Sep;28(7):615-22. doi: 10.1097/AJP.0b013e31823e16b9.
- Results publication: PubMed 15210879Moseley GL. Why do people with complex regional pain syndrome take longer to recognize their affected hand? Neurology. 2004 Jun 22;62(12):2182-6. doi: 10.1212/01.wnl.0000130156.05828.43.
- Results publication: PubMed 30703633Williams LJ, Braithwaite FA, Leake HB, McDonnell MN, Peto DK, Lorimer Moseley G, Hillier SL. Reliability and validity of a mobile tablet for assessing left/right judgements. Musculoskelet Sci Pract. 2019 Apr;40:45-52. doi: 10.1016/j.msksp.2019.01.010. Epub 2019 Jan 24.
- Derived from this study: PubMed 35961062Akcay S, Koskderelioglu A, Ince B, Elif Saka F, Eskut N, Goksel Karatepe A. Is the left/right judgment task performance altered in unilateral carpal tunnel syndrome: And associated with symptom severity? Musculoskelet Sci Pract. 2022 Dec;62:102641. doi: 10.1016/j.msksp.2022.102641. Epub 2022 Aug 4.
- Individual participant dataSharing planned: No. The clinical study report will be shared at the end of the study.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Seniz Akcay, Assoc Prof study director
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Altinay Goksel Karatepe, Prof study chair
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Fikriye Elif Saka, MD study chair
University of Health Sciences Izmir Bozyaka Training and Research Hospital
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, run by Bozyaka Training and Research Hospital 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 4 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 22 Feb 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?
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?
Left/right judgement Task (time frame: 3 months). 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 NCT04967144, which also lists 5 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 22 Feb 2022.