Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome

NCT ID: NCT06649461

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2024-11-05

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome (CTS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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ozone injections

Group Type EXPERIMENTAL

ozone injections

Intervention Type 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

Intervention Type OTHER

hand splint for night

splint

Group Type ACTIVE_COMPARATOR

Splint

Intervention Type OTHER

hand splint for night

Interventions

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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).

Intervention Type PROCEDURE

Splint

hand splint for night

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Emine Cihan

Assist. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024/10.6

Identifier Type: -

Identifier Source: org_study_id

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