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Trial · NCT07433257

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryVisual Analog Scale (VAS)before treatment, 4 weeks after treatment, 12 weeks after treatment
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Higher scores correspond to greater pain severity.
PrimaryTinel Signbefore treatment, 4 weeks after treatment, 12 weeks after treatment
The Tinel sign will be conducted by a physician by percussing over the median nerve at the wrist. A positive sign is identified by the occurrence of tingling or "pins and needles" sensations in the palm, thumb, index finger, or middle finger. Findings will be documented as positive or negative.
PrimaryPhalen Testbefore treatment, 4 weeks after treatment, 12 weeks after treatment
The Phalen test will be performed by a physician to assess median nerve compression. A positive test is defined as the reproduction of pain or paresthesia in the palmar region, thumb, index finger, or middle finger during sustained wrist flexion. Test results will be recorded as positive or negative.
PrimaryBoston Carpal Tunnel Syndrome Questionnaire (BCTSQ)before treatment, 4 weeks after treatment, 12 weeks after treatment
The Boston Carpal Tunnel Syndrome Questionnaire is a patient-reported outcome measure with two subscales: the Symptom Severity Scale and the Functional Status Scale. The Symptom Severity Scale includes 11 items assessing symptoms such as pain, paresthesia, numbness, weakness, nocturnal complaints, and difficulty grasping objects. The Functional Status Scale consists of 8 items evaluating hand-related functional abilities, including writing, buttoning clothes, holding a book while reading, gripping a telephone, opening jars, performing household activities, carrying shopping bags, and personal care tasks. Each item is scored on a 5-point Likert scale from 1 (no symptoms or no difficulty) to 5 (very severe symptoms or inability to perform the activity). Mean scores are calculated separately for each subscale, ranging from 1 to 5, with higher scores indicating greater symptom severity or poorer hand function. The validated Turkish version of the questionnaire was used.
PrimarySelf-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)before treatment, 4 weeks after treatment, 12 weeks after treatment
The Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) is a self-reported questionnaire used to evaluate neuropathic pain. Total scores range from 0 to 24, with higher scores indicating greater neuropathic pain severity. A score of 12 or higher is considered indicative of neuropathic pain. The validated Turkish version of the questionnaire will be used in this study
PrimaryHand Grip Strengthbefore treatment, 4 weeks after treatment, 12 weeks after treatment
Hand grip strength will be measured using a hand-held dynamometer . Three measurements will be obtained, and the mean value will be recorded in kilograms (kg). Higher values indicate greater muscle strength.
PrimaryPinch Strengthbefore treatment, 4 weeks after treatment, 12 weeks after treatment
Pinch strength will be assessed using a pinchmeter , including tip pinch, lateral pinch, and palmar pinch. Each measurement will be repeated three times, and the average value will be recorded in kilograms (kg). Higher values indicate greater muscle strength.
SecondaryMedian Nerve Cross-Sectional Area (MNCSA)before treatment, 4 weeks after treatment, 12 weeks after treatment
The Median Nerve Cross-Sectional Area (MNCSA) will be evaluated using ultrasonography at the level of the carpal tunnel inlet, defined anatomically by the scaphoid bone on the radial side and the pisiform bone on the ulnar side. The median nerve will be imaged in the transverse plane, and the cross-sectional area will be measured by manually tracing the hyperechoic epineurial border surrounding the nerve. Each measurement will be repeated three times, and the mean value will be used for analysis.
SecondaryMedian Nerve Sensory Distal Latencybefore treatment, 12 weeks after treatment
Median nerve sensory distal latency will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the time interval between electrical stimulation and the recorded sensory response of the median nerve. Results will be reported in milliseconds (ms).
SecondaryMedian Sensory Nerve Action Potential Amplitudebefore treatment, 12 weeks after treatment
Median sensory nerve action potential amplitude will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the magnitude of the recorded sensory response of the median nerve following electrical stimulation. Results will be reported in microvolts (µV).
SecondaryMedian Nerve Sensory Conduction Velocitybefore treatment, 12 weeks after treatment
Median nerve sensory conduction velocity will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the speed of impulse transmission along the sensory fibers of the median nerve. Results will be reported in meters per second (m/s).
SecondaryMedian Nerve Motor Distal Latencybefore treatment, 12 weeks after treatment
Median nerve motor distal latency will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the time interval between distal electrical stimulation and the recorded motor response of the median nerve. Results will be reported in milliseconds (ms).
SecondaryMedian Nerve Compound Muscle Action Potential Amplitudebefore treatment, 12 weeks after treatment
Median nerve compound muscle action potential (CMAP) amplitude will be measured using electromyography (EMG) with nerve conduction studies (NCS) following stimulation of the median nerve. The parameter represents the magnitude of the recorded motor response. Results will be reported in millivolts (mV).
SecondaryMedian Nerve Motor Conduction Velocitybefore treatment, 12 weeks after treatment
Median nerve motor conduction velocity will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the speed of impulse transmission along the motor fibers of the median nerve. Results will be reported in meters per second (m/s).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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