A Phase 4 interventional study of Static wrist splint treatment and Tendon and nerve gliding exercises in Carpal Tunnel Syndrome, sponsored by Abant Izzet Baysal University. Active, not recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Abant Izzet Baysal University · Phase 4, Interventional, and Treatment
It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.
Carpal tunnel syndrome (CTS) is one of the most common entrapment neuropathies. It occurs as a result of compression or irritation of the median nerve as it passes through the carpal tunnel in the wrist. It is seen in 1-4% of the general population.In nerve conduction studies, patients with mild and moderate CTS are treated with conservative treatment methods, while patients with severe nerve conduction findings and thenar atrophy are treated surgically.Although there are many methods used in the conservative treatment of carpal tunnel syndrome, there is no definite data about which treatment option to choose.The most commonly used conservative method is the wrist rest splint application, which is based on the principle of resting the wrist.In addition, there are tendon and nerve gliding exercises that facilitate nerve and tendon movements. Physical therapy agents such as Tens, Laser and Ultrasound can be used in the treatment of CTS. Non-Steroidal anti-inflammatory drugs and B6 vitamins can be used as drug therapy. Apart from these, local corticosteroid injections can be applied from the wrist.
There are studies comparing conservative treatment methods in carpal tunnel syndrome. However, these are generally in the form of studies that measure and compare the effects of treatments on the clinical condition of their patients and on hand grip and finger pinch strength. There is no comparative study investigating the effects of conservative treatment methods on wrist muscle strength in patients with carpal tunnel syndrome.
It was observed that wrist muscle strength decreased in patients with CTS compared to normal patients. Wrist muscle strength is important in hand and wrist functions as well as hand grip and pinch strength are important.
Flexion-extension, radial-ulnar deviation and supination-pronation muscle strengths of the patients' wrists can be measured with an isokinetic dynamometer device.
It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.
It will be organized as a prospective randomized study. It is planned to include 60 patients in the study. Patients will be randomized into three groups in equal numbers, stratified by age and sex.
Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.
Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week .
Patients in Group 3 will be applied to local steroid injection the wrist in addition to static wrist splint treatment for 8 week.
Demographic data, medical history, dominant and CTS hand information will be recorded at the beginning of the patients.
Patients in both groups will be evaluated before the treatment, at the 8th week after treatment.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.
Device: Static wrist splint treatment
Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week.
Device: Static wrist splint treatment · Other: Tendon and nerve gliding exercises
Patients in Group 3 will be applied to local steroid injection to wrist in addition to static wrist splint treatment for 8 week.
Device: Static wrist splint treatment · Drug: Wrist local steroid injection
Static wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks.
Tendon and nerve gliding exercises will be applied 5 sessions a day for 8 weeks. Each session will hold 10 repetitions and approximately 7 seconds in each exercise position. These exercises involve a sequence of finger movements (for tendon gliding) and wrist and fingers movements (for median nerve gliding).
Wrist local steroid injection: After proper area cleaning with povidone solution, 1ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml) steroid injection will be applied around the median nerve with a 22 G injector from ulnar side of the wrist proximal crease under ultrasound guidance.
Visual Analogue Scale
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Time frame: Before Treatment
Visual Analogue Scale
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Time frame: 8 week after treatment
Isokinetic Muscle Strength Measure
Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.
Time frame: Before Treatment
Isokinetic Muscle Strength Measure
Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.
Time frame: 8 week after treatment
The hand grip strength
The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.
Time frame: Before Treatment
The hand grip strength
The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.
Time frame: 8 week after treatment
The finger pinch strength
Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
Time frame: Before Treatment
The finger pinch strength
Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
Time frame: 8 week after treatment
Boston Carpal Tunnel Syndrome Questionnaire
This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.
Time frame: Before Treatment
Boston Carpal Tunnel Syndrome Questionnaire
This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.
Time frame: 8 week after treatment
Disabilities of the Arm, Shoulder end Hand Questionnaire
The Disabilities of the Arm, Shoulder end Hand Questionnaire (DASH) consists of 3 parts: the functional/symptom model, the business model, and the sports/musicians model. The individual fills himself. In this study, functional/symptom and business model sections will be used. A score between 0-100 is obtained from each section. High score increases handicap.
Time frame: Before Treatment
Disabilities of the Arm, Shoulder end Hand Questionnaire
The Disabilities of the Arm, Shoulder end Hand Questionnaire (DASH) consists of 3 parts: the functional/symptom model, the business model, and the sports/musicians model. The individual fills himself. In this study, functional/symptom and business model sections will be used. A score between 0-100 is obtained from each section. High score increases handicap.
Time frame: 8 week after treatment
Short Form-36 Quality of Life Scale
The patients' quality of life will be evaluated with the Short Form-36 Quality of Life Scale. It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.
Time frame: Before Treatment
Short Form-36 Quality of Life Scale
The patients' quality of life will be evaluated with the Short Form-36 Quality of Life Scale. It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.
Time frame: 8 week after treatment
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Abant Izzet Baysal University