Carpal Tunnel Syndrome (CTS)NCT07847450
Measurement of Muscle Strength Using a Manual Muscle Tester in Women With Electrophysiologically Confirmed Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS), run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this cross-sectional study is to evaluate muscle strength in female patients with carpal tunnel syndrome (CTS) who have only sensory involvement detected on electromyography. Muscle strength will be assessed using the "Lafayette Manual Muscle Tester®". The main questions of the study are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2026to Feb 2027
- Phase
- Observational
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who applied to the Bezmialem Vakıf University, Neurology Outpatient Clinic appropriate for eligibility criteria will be enrolled
Who may be able to join
- Age ≥18 years.
- Female sex.
- Unilateral or bilateral carpal tunnel syndrome according to the Boston Carpal Tunnel Syndrome criteria.
- Sensory or motor involvement on electromyography (EMG).
- Paresthesia, pain, or numbness in the area of the hand innervated by the median nerve for more than 3 months.
- Presence of Tinel's and Phalen's signs.
Who cannot join
- History of hand surgery.
- Severe cardiovascular disease.
- Neuromuscular disease affecting muscle strength.
- Gout.
- History of hand trauma.
- History of rheumatoid arthritis or osteoarthritis of the hand or wrist.
- Pregnancy.
- Cervical radiculopathy or any upper extremity neuropathy other than carpal tunnel syndrome.
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
Bezmialem Vakif University
Istanbul, Fatih, 34093
Ozan Volkan Yurdakul, Prof., +902124530453, yurdakul_ozan@yahoo.com
Zeynep Altun, +905442298891, zeynepaltunn@gmail.com
About this study
The aim of this cross-sectional study is to evaluate muscle strength in female patients with carpal tunnel syndrome (CTS) who have only sensory involvement detected on electromyography. Muscle strength will be assessed using the "Lafayette Manual Muscle Tester®".
The main questions of the study are:
Read more
- Is there a difference in muscle strength between healthy individuals and female patients with carpal tunnel syndrome?
- Is there a difference in muscle strength between female patients with carpal tunnel syndrome who have only sensory involvement and those who have both sensory and motor involvement?
- Are there differences in the strength of thumb palmar abduction and adduction, radial adduction and abduction, thumb flexion, extension and opposition, and flexion of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the fingers between these groups?
The investigators will measure the muscle strength associated with these movements using the "Lafayette Manual Muscle Tester®" in order to objectively evaluate motor involvement in female patients with carpal tunnel syndrome and to compare muscle strength between healthy individuals and patients with different degrees of electrophysiological involvement.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and develops as a result of compression of the median nerve within the carpal tunnel at the level of the wrist. It manifests with pain in the wrist and hand, paresthesia and sensory loss in the dermatome of the median nerve in the hand (paresthesias may sometimes extend to the entire hand and even the arm), as well as weakness in thumb abduction, opposition, and flexion, and flexion of the second and third fingers at the metacarpophalangeal joints. The carpal tunnel is a structure located in the proximal palmar region of the wrist, bounded superiorly by connective tissue and the carpal ligament and inferiorly by the carpal bones, through which the median nerve and flexor tendons pass. The motor fibers of the median nerve passing through the carpal tunnel innervate the thenar muscle group (abductor pollicis brevis, flexor pollicis brevis-superficial head, and opponens pollicis), as well as the first and second lumbrical muscles; its sensory fibers provide innervation to the first three digits and the lateral aspect of the fourth digit
Among the risk factors for this common entrapment neuropathy are female sex, obesity, age, occupations and activities involving repetitive rotational and flexion movements of the hand, trauma, and pregnancy . The diagnosis of CTS is primarily clinical. It is established based on typical signs and symptoms, such as hand and wrist pain, symptoms occurring or worsening at night, relief with shaking of the hand, and positive Tinel and Phalen signs. Electrophysiological studies (nerve conduction studies and needle electromyography) are used both to confirm the diagnosis of CTS and to exclude other conditions included in the differential diagnosis, such as polyneuropathy, hereditary neuropathy with liability to pressure palsies, and C6 radiculopathy. Nerve ultrasonography (US) is also valuable for demonstrating compression of the median nerve within the carpal tunnel and can additionally identify other lesions affecting the nerve at this level, such as a ganglion cyst .
Although patients with CTS may not have overt motor involvement, clumsiness and impairment of fine motor functions are frequently observed. It has been suggested that these findings may result from impaired sensory feedback required for motor coordination or from a central sensory-motor integration disorder
Changes in muscle strength in patients with sensory involvement only on electromyography can be measured precisely using hand-held dynamometers . Hand-held dynamometers have long been used for the objective assessment of muscle strength. In recent years, electronic versions of these devices have been developed. In our study, muscle strength will be objectively assessed using the "Lafayette Manual Muscle Tester®" by measuring the force exerted by the relevant muscle group during isometric contraction against the measurement pad of the device. Quantitative parameters, including peak force, mean force, and time-dependent changes in force, will be obtained.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CTS-affected hand | Participants with unilateral or bilateral carpal tunnel syndrome according to the Boston Carpal Tunnel Syndrome criteria will be admitted to this group. Median and ulnar sensory and motor nerve conduction studies will be performed in both upper extremities. The comparison of the peak latency of the median and ulnar sensory responses with fourth-finger stimulation will be performed. Needle electromyography will be performed when necessary to exclude radiculopathy. Muscle strength of thumb palmar abduction, radial abduction, thumb flexion, extension and opposition, and proximal and distal interphalangeal joint flexion of the fingers will be evaluated using a hand-held dynamometer (Lafayette Manual Muscle Tester®). | |
| Healthy Control Group | Participants without carpal tunnel syndrome will be included in this group. Muscle strength of thumb palmar abduction, radial abduction, thumb flexion, extension and opposition, and proximal and distal interphalangeal joint flexion of the fingers will be evaluated using a hand-held dynamometer (Lafayette Manual Muscle Tester®). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
A questionnaire consisting of 11 questions assessing symptom severity and 8 questions assessing functional status. Higher scores indicate greater disease severity. The Turkish version of the questionnaire has demonstrated validity and reliability. Numerical Rating Scale (NRS), A scale in which patients rate their pain on a numerical scale from 0 to 10. Higher scores indicate greater pain intensity.
Measured: 1 day
Phalen Test
The patient is asked to flex both wrists and hold the dorsal surfaces of the hands together for 60 seconds. The test is considered positive if pain or paresthesia occurs in the areas innervated by the median nerve, including the thumb, second and third fingers, the radial half of the fourth finger, or the forearm.
Measured: 1 day
Durkan Test
The patient's forearm is placed in supination, and pressure is applied over the median nerve between the thenar and hypothenar eminences for 30 seconds. The test is considered positive if paresthesia or pain is experienced.
Measured: 1 day
Tinel Test
In the symptomatic hand, the distal portion of the palmaris longus tendon near the palmar aspect of the wrist is gently percussed with a neurological reflex hammer. The test is considered positive if paresthesia or pain is experienced.
Measured: 1 day
Electrophysiological Tests
Median and ulnar sensory and motor nerve conduction studies will be performed in both upper extremities. The peak latency of the median and ulnar sensory responses with fourth-finger stimulation will be compared. Needle electromyography will be performed when necessary to exclude radiculopathy.1
Measured: 1 day
Thumb Palmar Abduction
The hand will be stabilized with the dorsal surface facing the table. The thumb will be positioned in maximum palmar abduction, perpendicular to the plane of the palm. The measurement pad of the device will be placed on the radial aspect of the proximal phalanx of the thumb. The patient will be instructed to push against the measurement pad with maximum force.Thumb Palmar Abduction Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Thumb Radial Abduction Muscle Strength
The forearm will be positioned in supination with the palm facing upward. The patient will be instructed to move the thumb away from the palm in the radial direction. The measurement pad will be placed against the radial aspect of the proximal phalanx of the thumb, and the patient will be instructed to perform maximal radial abduction against the pad. Radial Abduction Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Thumb Extension Muscle Strength
The hand will be stabilized with the dorsal surface facing the table, and the patient will be asked to lift the thumb upward in the sagittal plane. The measurement pad will be positioned against the radial aspect of the distal phalanx of the thumb, and the patient will be instructed to push against the pad with maximum force. Thumb Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Thumb Opposition Muscle Strength
The measurement device will be placed in the palm, with the measurement pad positioned at the level of the fifth finger. The patient will be instructed to perform thumb opposition and push against the measurement pad with maximum force. Thumb Opposition Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Thumb IP Flexion Muscle Strength
The measurement device will be stabilized on a flat surface while the patient performs flexion of the thumb interphalangeal (IP) joint. The patient will be instructed to press the fingertip against the measurement pad with maximum force. Thumb IP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Thumb MCP Flexion Muscle Strength
The measurement device will be placed in the palm, with the measurement pad positioned over the third metacarpophalangeal (MCP) joint. The patient will be instructed to perform thumb MCP flexion and push against the measurement pad with maximum force.Thumb MCP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Second Finger PIP Flexion
The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the proximal interphalangeal (PIP) joint of the second finger and press the fingertip against the measurement pad with maximum force. Second finger pıp flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Second Finger DIP Flexion Muscle Strength
The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the distal interphalangeal (DIP) joint of the second finger while the metacarpophalangeal (MCP) and distal interphalangeal (DIP) joints are stabilized and press the fingertip against the measurement pad with maximum force. Second Finger DIP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Third Finger PIP Flexion Muscle Strength
The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the proximal interphalangeal (PIP) joint of the third finger and press the fingertip against the measurement pad with maximum force. Third Finger PIP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 day
Third Finger DIP Flexion muscle strength
The third finger will be positioned with the MCP and PIP joints stabilized. The measurement pad will be positioned against the palmar aspect of the distal phalanx. The patient will be instructed to perform maximal flexion of the DIP joint against the pad.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847450
- Sponsor's protocol ID
- 2026/130
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu X, Zhan S, Wang H, Liu J, Xiang L, Zhang B, Huang D, Gong F. Analysis of motor axonal damage in carpal tunnel syndrome using MScanFit MUNE. J Hand Ther. 2026 Apr-Jun;39(2):387-397. doi: 10.1016/j.jht.2025.09.003. Epub 2025 Nov 18.
PubMed 41253581Simao AS, Paranhos DB, Gasparini ALP, Sousa LAPS, Fernandes LFRM. Increased electromyographic activity of the abductor pollicis brevis and hand strength deficits in women with carpal tunnel syndrome: A cross-sectional study. J Hand Ther. 2026 Jan-Mar;39(1):283-292. doi: 10.1016/j.jht.2025.05.005. Epub 2025 Jun 18.
PubMed 40533330Marquardt TL, Nataraj R, Evans PJ, Seitz WH Jr, Li ZM. Carpal tunnel syndrome impairs thumb opposition and circumduction motion. Clin Orthop Relat Res. 2014 Aug;472(8):2526-33. doi: 10.1007/s11999-014-3651-5. Epub 2014 Apr 29.
PubMed 24777728Neral M, Imbriglia JE, Carlson L, Wollstein R. Motor Examination in the Diagnosis of Carpal Tunnel Syndrome. J Hand Microsurg. 2017 Aug;9(2):67-73. doi: 10.1055/s-0037-1603346. Epub 2017 May 25.
PubMed 28867905Liu F, Carlson L, Watson HK. Quantitative abductor pollicis brevis strength testing: reliability and normative values. J Hand Surg Am. 2000 Jul;25(4):752-9. doi: 10.1053/jhsu.2000.6462.
PubMed 10913219Matur Z, Dortcan N, Imisci S, Suner M, Acar Z, Sozer N, Oge AE. Frequent object dropping in carpal tunnel syndrome: a consequence of impaired sensorimotor integration? Brain Res. 2025 Dec 15;1869:150029. doi: 10.1016/j.brainres.2025.150029. Epub 2025 Nov 2.
PubMed 41187823Ng AWH, Griffith JF, Lee RKL, Tse WL, Wong CWY, Ho PC. Ultrasound carpal tunnel syndrome: additional criteria for diagnosis. Clin Radiol. 2018 Feb;73(2):214.e11-214.e18. doi: 10.1016/j.crad.2017.07.025. Epub 2017 Aug 30.
PubMed 28859853Kaczmarek K, Peplinski J, Kaczmarek A, Andrzejuk D, Andruszkiewicz K, Wysocka A, Witkowska M, Huber J. Correlations of Tinel and Phalen Signs with Nerve Conduction Study Test Results in a Randomly Chosen Population of Patients with Carpal Tunnel Syndrome. NeuroSci. 2025 Sep 28;6(4):94. doi: 10.3390/neurosci6040094.
PubMed 41133630Mondelli M, Aprile I, Ballerini M, Ginanneschi F, Reale F, Romano C, Rossi S, Padua L. Sex differences in carpal tunnel syndrome: comparison of surgical and non-surgical populations. Eur J Neurol. 2005 Dec;12(12):976-83. doi: 10.1111/j.1468-1331.2005.01099.x.
PubMed 16324091Omole AE, Awosika A, Khan A, Adabanya U, Anand N, Patel T, Edmondson CK, Fakoya AO, Millis RM. An Integrated Review of Carpal Tunnel Syndrome: New Insights to an Old Problem. Cureus. 2023 Jun 8;15(6):e40145. doi: 10.7759/cureus.40145. eCollection 2023 Jun.
PubMed 37304388Cranford CS, Ho JY, Kalainov DM, Hartigan BJ. Carpal tunnel syndrome. J Am Acad Orthop Surg. 2007 Sep;15(9):537-48. doi: 10.5435/00124635-200709000-00004.
PubMed 17761610