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Active, not recruiting Phase 4

Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome

NCT05475808 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 4
Started
2022-08-01
Last updated
2025-02-27

Condition(s) studied

Carpal Tunnel Syndrome

Investigational drug(s) / intervention(s)

Static wrist splint treatmentTendon and nerve gliding exercisesWrist local steroid injection

Static wrist splint treatment: 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: 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: 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.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with mild to moderate CTS confirmed by Electromyography * Clinically, at least one of the symptoms of hand-wrist pain, numbness, night pain should be present. * Clinically, at least one of the Tinel, Phalen, and median nerve compression findings should be present. Exclusion Criteria: * Having a history of trauma and operation on the wrist. * Patients who have had previous injections from the wrist * Patients with thyroid diseases, diabetes mellitus, systemic peripheral neuropathy and cervical radiculopathy * Pregnant patients

Primary outcome measure(s)

  • Visual Analogue Scale — Before Treatment
    Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
  • Visual Analogue Scale — 8 week after treatment
    Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
  • Isokinetic Muscle Strength Measure — Before Treatment
    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.
  • Isokinetic Muscle Strength Measure — 8 week after treatment
    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.
  • The hand grip strength — Before Treatment
    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.
  • The hand grip strength — 8 week after treatment
    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.
  • The finger pinch strength — Before Treatment
    Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
  • The finger pinch strength — 8 week after treatment
    Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
  • Boston Carpal Tunnel Syndrome Questionnaire — Before Treatment
    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.
  • Boston Carpal Tunnel Syndrome Questionnaire — 8 week after treatment
    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.

Trial sites (1)

FacilityCityRegionStatus
Abant Izzet Baysal University Bolu Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05475808 on ClinicalTrials.gov ↗ ← All trials in Turkey