Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome

Evaluation of the Effectiveness of Splint Use in Different Wrist Positions in the Treatment of Carpal Tunnel Syndrome: A Single-Blind, Randomized, Controlled Trial

Carpal tunnel syndrome (CTS) is the most common nerve compression syndrome. It develops as a result of the compression of the median nerve while passing through the osteofibrous structure of the carpal tunnel located at the wrist. Sensory symptoms are the most prominent feature of CTS. These symptoms are observed as pain, paresthesia, and decreased sensory sensitivity. As motor symptoms, thumb abduction and opposition are primarily affected. In advanced cases, atrophy develops in the thenar muscles. Patients may describe weakness as difficulty in writing, opening jars, buttoning, or grasping objects. The diagnosis is made by fulfilling both clinical and electrophysiological diagnostic criteria. CTS has both conservative and surgical treatment options. Conservative treatment includes splinting, physical therapy modalities, and injection options, and it is preferred in mild and moderate cases. Among non-surgical treatment options, splint use is a commonly applied intervention; however, there is no consensus regarding its effectiveness, the optimal wrist position during use, or the duration and frequency of splint application. A total of 108 hands from patients aged 18 to 55 years diagnosed with CTS will be included in this study and randomized into three groups. All groups will be given an education and exercise program. The first group will use a wrist splint fixed at 15° flexion; the second group at neutral position; and the third group at 20° extension, to be worn only at night for eight weeks. Patients will be evaluated before treatment, immediately after treatment, and two months after the end of treatment using measures of pain- numbness severity, functional status, motor and sensory examination findings, and nerve conduction studies. What makes this study unique is that it evaluates the effects of splints that stabilize the wrist at different angles together with electrophysiological findings. A review of the literature shows that while some studies have examined and compared the effects of splints fixed at different wrist angles on symptoms, functional status, and physical examination findings, there is no study that evaluates these effects along with electrophysiological findings. Therefore, this study, which will compare the effectiveness of splints at different angles, is expected to contribute to the literature. The expected outcomes of this research are that one or more types of splints used in the conservative treatment of CTS will provide improvements in symptom severity, functional status, sensory and motor physical examination findings, and electrophysiological evaluation findings at the end of treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Neuropathies; Carpal Tunnel Syndrome (CTS); Median Nerve Entrapment
• Intervention / Treatment: Other: Flexion Splint; Behavioral: Education; Other: Exercise; Other: Neutral Splint; Other: Extension Splint

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of mild to moderate carpal tunnel syndrome confirmed by electrophysiological studies performed within the last year.
• Clinical findings consistent with carpal tunnel syndrome.
• Age between 18 and 65 years.

Exclusion Criteria:

• <18 years or >65 years
• Thenar atrophy
• Surgery history for CTS
• Steroid injection for CTS
• Physical treatment for CTS in the last 6 months
• Cervical radiculopathy
• Tenosynovitis
• Peripheral polyneuropathy
• Another compressive neuropathy in the ipsilateral upper extremity
• History of trauma/fracture to the hand-wrist region
• Pregnancy
• Metabolic disease
• Rheumatic/autoimmune disease
• Kidney failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 15° Flexion Wrist Splint Group	Other: Flexion Splint; Participants will wear wrist splint fixed at 15° of wrist flexion during nighttime only for eight weeks.; Behavioral: Education; All participants will also receive a standardized education.; Other: Exercise; All participants will also receive a standardized exercise program.
Active Comparator: Neutral Wrist Splint Group	Behavioral: Education; All participants will also receive a standardized education.; Other: Exercise; All participants will also receive a standardized exercise program.; Other: Neutral Splint; Participants will wear a wrist splint maintaining the wrist in a neutral position during nighttime only for eight weeks.
Active Comparator: 20° Extension Wrist Splint Group	Behavioral: Education; All participants will also receive a standardized education.; Other: Exercise; All participants will also receive a standardized exercise program.; Other: Extension Splint; Participants will wear a wrist splint fixed at 20° of wrist extension during nighttime only for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve Conduction Study (NCS)	Median motor distal latency and conduction velocity and second finger recorded median sensory distal latency and conduction velocity will be measured in all individuals. In addition to routine conduction examinations, fourth finger recorded median-ulnar peak latency comparison examinations will also be made.	Baseline and sixteen week of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Pain Scale (VAS)	Pain and numbness at rest, at night, and during movement will be assessed using a visual analog scale (VAS) ranging from 0 to 10, where 0 represents "no pain" and 10 represents "unbearable pain."	Baseline, eight week of intervention, sixteen week of intervention
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)	BCTSQ assesses the severity of symptoms and functional status in patients with carpal tunnel syndrome. The symptom severity scale assesses the symptoms with respect to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice responses, scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the mean of the scores for the eleven individual items. The functional status scale assesses the affect of the carpal tunnel syndrome on daily living. The scale consists of 8 questions with multiple choice responses, scored from 1 point (no difficulty with the activity) to 5 points (can not perform the activity at all). The overall score for functional status was calculated as the mean of all eight. Thus, a higher symptom severity or functional status score indicates worse symptoms or dysfunction.	Baseline, eight week of intervention, sixteen week of intervention
Semmes Weinstein Monofilament Test (SWMT)	Using 20 pieces of SWMT, sensitive touch threshold sensitivity of each hand will be tested. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. The monofilaments will be touched fingertips of first three fingers on the radial side of both hands, with enough force to bend the monofilament for 1.5 seconds. The thinnest monofilament numbers that the patient feels being touched will be recorded.	Baseline, eight week of intervention, sixteen week of intervention
Two Point Discrimination Test (TPDT)	Two point discrimination sense will be evaluated statically using an esthesiometer. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. The contact time of the discriminator with the fingertip ranged from 3 to 5 seconds. The evaluation will be started by touching a single point on the first three fingertips on the radial side of both hands. Each three fingers will be evaluated separately and the distance between the two touched points will be increased by 1mm in each measurement. The smallest values will be taken in millimeters which the patient feels the two points as two separate points on the tested hand will be noted and the the average value written as the result.	Baseline, eight week of intervention, sixteen week of intervention
Hand Grip Force	The squeeze force will be measured while the patients are sitting, with the elbow in 90 degrees flexion and they will be asked to make a maximally voluntary grip. Measurements will be made three times in a row on both hands and the average of the three measurements will be noted as a result in kilogram (kg).	Baseline, eight week of intervention, sixteen week of intervention
Thumb and Forefinger Pinch Force	The pinch force with thumb and forefinger will be measured while the patients are sitting, with the elbow in 90 degrees flexion and they will be asked to make a maximally voluntary grip.The pinch force will be measured as kg with a pinch dynamometer, and the average of the three measurements will be noted as a result.	Baseline, eight week of intervention, sixteen week of intervention
Manuel Muscle Testing of M. Abductor Pollicis Brevis	Manual muscle testing will be evaluated in 5 grades. No visible or palpable muscle contraction 0, visible or palpable muscle contraction without motion grade 1, muscle contraction that creates movement at full of range of motion when gravity is eliminated grade 2, muscle contraction that creates movement at full of range of motion against gravity grade 3, muscle contraction that creates movement at full of range of motion against gravity and moderate resistance grade 4, muscle contraction that creates movement through the entire range of motion of the joint against gravity and full resistance will be considered as the grade 5	Baseline, eight week of intervention, sixteen week of intervention
Vibration Sensation	Vibration sense was tested with tuning fork. The examiner and the subject will be seated opposite each other. Both arms of the subject will be arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. Vibrating tuning fork will be placed on the palmar aspect of the distal phalanx of first three fingers on the radial side of both hands, The patient will be asked to say 'done' when the vibration in his hand was over. The average of three measurements will be noted as a result in seconds.	Baseline, eight week of intervention, sixteen week of intervention

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Electromyography; Splints; Wrist splinting; Wrist posture
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Peripheral Nervous System Diseases; Carpal Tunnel Syndrome; Median Neuropathy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics; Exercise; Educational Status
• Other Study ID Numbers: E-29624016-050.99-3310018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No