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Enrolling by Invitation

NCT Number: NCT06649461

Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome

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.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ozone injections

Procedure

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

Other

hand splint for night

Primary outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire

    Time frame: 10 minutes

    As the score obtained from the survey increases, the improvement increases.

  2. visual analog scale

    Time frame: 1 minute

    As the score approaches 10, the intensity of pain felt increases.

  3. electromyography (EMG)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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