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Enrolling by invitation NCT06649461

Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome

No phase Interventional Carpal Tunnel Syndrome (CTS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ozone injections, Splint.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome (CTS). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Splint with Ozone Injection for Mild and Moderate Carpal Tunnel: an Electrodiagnostic Study

Overview

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.

Interventions

  • Procedure 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).
  • Other Splint
    hand splint for night

Primary outcome measures

  • Boston Carpal Tunnel Syndrome Questionnaire [Time frame: 10 minutes]
  • visual analog scale [Time frame: 1 minute]
  • electromyography (EMG) [Time frame: 10 minutes]

Eligibility criteria

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).

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

Turkey (Türkiye) · 1 center
  • Kocaeli University — Kocaeli

Identifiers

NCT: NCT06649461 · 2024/10.6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗