Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
<18 years or >65 years
Thenar atrophy
Surgery history for CTS
Steroid injection for CTS
Trial design
Design model
Parallel
Treatments tested in this trial
Flexion Splint
Other interventionParticipants will wear wrist splint fixed at 15° of wrist flexion during nighttime only for eight weeks.
Neutral Splint
Other interventionParticipants will wear a wrist splint maintaining the wrist in a neutral position during nighttime only for eight weeks.
Extension Splint
Other interventionParticipants will wear a wrist splint fixed at 20° of wrist extension during nighttime only for eight weeks.
Education
BehavioralAll participants will also receive a standardized education.
Exercise
Other interventionAll participants will also receive a standardized exercise program.
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: 15° Flexion Wrist Splint GroupActive comparator 3 interventions
Group B: Neutral Wrist Splint GroupActive comparator 3 interventions
Group C: 20° Extension Wrist Splint GroupActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and sixteen week of interventionSecondary outcomes
1
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."
Time frame
Baseline, eight week of intervention, sixteen week of intervention2
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.
Time frame
Baseline, eight week of intervention, sixteen week of intervention3
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.
Time frame
Baseline, eight week of intervention, sixteen week of intervention4
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.
Time frame
Baseline, eight week of intervention, sixteen week of interventionLocations
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Source ClinicalTrials.gov
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