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Enrolling by invitation Not applicable

Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome

NCT06649461 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-10-15
Last updated
2024-10-18

Condition(s) studied

Carpal Tunnel Syndrome (CTS)

Investigational drug(s) / intervention(s)

ozone injectionsSplint

ozone injections: Ozone injections (5 mL/10 μg/dL) were administered under aseptic conditions, with the wrist fixed in dorsiflexion, and with the insulin injector, a 23-gauge needle was inserted between the palmaris longus and flexor carpi radialis muscles at a 45-degree angle from the palmar distal line (Salutem/19147884379).

Splint: hand splint for night

Study summary

This study will investigate the effectiveness of repeated ozone therapy combined with splint therapy for carpal tunnel syndrome (CTS).CTS patients will be split into two groups: ozone plus splint and splint only. Both groups will use wrist splints for 3 weeks, with the ozone+splint group receiving weekly ozone injections for three weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * being 18-65 years, with mil-modarete CTS, symptoms continued for at least 3 months Exclusion Criteria: * hand edema or prior injections, thenar atrophy, prior CTS surgery, severe EMG results, recent physical therapy, steroids, or platelet-rich plasma for CTS in the past year, and conditions causing secondary CTS (e.g., thyroid disorders, diabetes, pregnancy, rheumatoid arthritis, Dupuytren's contracture, inflammatory arthritis, connective tissue diseases). Also excluded: neck or arm pain conditions (e.g., cervical disc herniation, wrist fracture, proximal upper extremity entrapment neuropathy, polyneuropathy, peripheral nerve damage, fibromyalgia), history of G6PD deficiency, uncontrolled hyperthyroidism, thrombocytopenia, and contraindications to general ozone therapy (e.g., ACE inhibitors for severe cardiovascular instability).

Primary outcome measure(s)

  • Boston Carpal Tunnel Syndrome Questionnaire — 10 minutes
    As the score obtained from the survey increases, the improvement increases.
  • visual analog scale — 1 minute
    As the score approaches 10, the intensity of pain felt increases.
  • electromyography (EMG) — 10 minutes
    In the electrophysiological examination, median sensory nerve conduction studies and median motor nerve conduction studies will be measured. Median motor nerve latency, median motor nerve conduction velocity, and compound muscle action potential amplitude will be measured and recorded.

Trial sites (1)

FacilityCityRegionStatus
Kocaeli University Kocaeli 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 NCT06649461 on ClinicalTrials.gov ↗ ← All trials in Turkey