Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome

NCT07458152 | Not Yet Recruiting

• 1 other identifier: E-29624016-050.99-3310018
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS); Peripheral Neuropathies; Median Nerve Entrapment

Keywords

Splints; Electromyography; Wrist splinting; Rehabilitation; Wrist posture

Outcome Measures

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.

  Baseline and sixteen week of intervention

Secondary Outcomes (8)

• Visual Pain Scale (VAS)

  Baseline, eight week of intervention, sixteen week of intervention

• Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)

  Baseline, eight week of intervention, sixteen week of intervention

• Semmes Weinstein Monofilament Test (SWMT)

  Baseline, eight week of intervention, sixteen week of intervention

• Two Point Discrimination Test (TPDT)

  Baseline, eight week of intervention, sixteen week of intervention

• Hand Grip Force

  Baseline, eight week of intervention, sixteen week of intervention

Study Arms (3)

15° Flexion Wrist Splint Group

ACTIVE COMPARATOR

Other: Flexion Splint; Behavioral: Education; Other: Exercise

Neutral Wrist Splint Group

ACTIVE COMPARATOR

Other: Neutral Splint; Behavioral: Education; Other: Exercise

20° Extension Wrist Splint Group

ACTIVE COMPARATOR

Other: Extension Splint; Behavioral: Education; Other: Exercise

Interventions

Flexion Splint OTHER

Participants will wear wrist splint fixed at 15° of wrist flexion during nighttime only for eight weeks.

15° Flexion Wrist Splint Group

Neutral Splint OTHER

Participants will wear a wrist splint maintaining the wrist in a neutral position during nighttime only for eight weeks.

Neutral Wrist Splint Group

Extension Splint OTHER

Participants will wear a wrist splint fixed at 20° of wrist extension during nighttime only for eight weeks.

20° Extension Wrist Splint Group

Education BEHAVIORAL

All participants will also receive a standardized education.

15° Flexion Wrist Splint Group; 20° Extension Wrist Splint Group; Neutral Wrist Splint Group

Exercise OTHER

All participants will also receive a standardized exercise program.

15° Flexion Wrist Splint Group; 20° Extension Wrist Splint Group; Neutral Wrist Splint Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Peripheral Nervous System Diseases; Median Neuropathy

Interventions

Educational Status; Exercise

Condition Hierarchy (Ancestors)

Mononeuropathies; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03