Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome

Official title

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

Overview

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.

Interventions

• Other Flexion Splint
  Participants will wear wrist splint fixed at 15° of wrist flexion during nighttime only for eight weeks.
• Other Neutral Splint
  Participants will wear a wrist splint maintaining the wrist in a neutral position during nighttime only for eight weeks.
• Other Extension Splint
  Participants will wear a wrist splint fixed at 20° of wrist extension 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.

Primary outcome measures

• Nerve Conduction Study (NCS) [Time frame: Baseline and sixteen week of intervention]

Secondary outcome measures (8)

• Visual Pain Scale (VAS) [Time frame: Baseline, eight week of intervention, sixteen week of intervention]
• Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) [Time frame: Baseline, eight week of intervention, sixteen week of intervention]
• Semmes Weinstein Monofilament Test (SWMT) [Time frame: Baseline, eight week of intervention, sixteen week of intervention]
• Two Point Discrimination Test (TPDT) [Time frame: Baseline, eight week of intervention, sixteen week of intervention]
• Hand Grip Force [Time frame: Baseline, eight week of intervention, sixteen week of intervention]
• Thumb and Forefinger Pinch Force [Time frame: Baseline, eight week of intervention, sixteen week of intervention]
• Manuel Muscle Testing of M. Abductor Pollicis Brevis [Time frame: Baseline, eight week of intervention, sixteen week of intervention]
• Vibration Sensation [Time frame: Baseline, eight week of intervention, sixteen week of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07458152 · E-29624016-050.99-3310018

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗