Ozone Therapy in Patients With Carpal Tunnel Syndrome

NCT ID: NCT06469931

Last Updated: 2024-06-24

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-09-20

Brief Summary

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ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting.

Detailed Description

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Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy resulting from compression of the median nerve at the wrist level. Various methods are applied in the conservative treatment of CTS. These include modification of daily life, splinting, physical therapy modalities and exercise methods. ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Ozone therapy has trophic effects, analgesic effects, antioxidant, immunomodulator, anti-inflammatory and antitumoral effects. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting. Ultrasonographic examinations of the median nerve cross-sectional area will be performed using a LOGIQ P5 (Healthcare Ultrasound, Korea) and a high frequency 7-12 MHz linear probe. A hand dynamometer will be used to assess the grip strength of the hand.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ozone therapy group

In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.

Group Type EXPERIMENTAL

range of motion exercises

Intervention Type OTHER

In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.

ozone therapy

Intervention Type OTHER

ozone therapy

Extracorporeal shock wave therapy group

Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercisess for wrist and hand and splinting.

Group Type EXPERIMENTAL

range of motion exercises

Intervention Type OTHER

In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.

Extracorporeal shock wave therapy

Intervention Type DEVICE

Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercises for wrist and hand and splinting.

Interventions

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range of motion exercises

In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.

Intervention Type OTHER

Extracorporeal shock wave therapy

Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercises for wrist and hand and splinting.

Intervention Type DEVICE

ozone therapy

ozone therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 18-65 who have been complaining for at least 3 months
* Diagnosed with mild or moderate Carpal Tunnel Syndrome

Exclusion Criteria

* Cervical disc herniation or radiculopathy,
* Brachial plexus lesion
* Previous hand or neck surgery
* Pregnancy,
* History of fracture at the wrist level
* Inflammatory rheumatic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Firat University

OTHER

Sponsor Role lead

Responsible Party

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Songül Bağlan Yentür

Head of Physiotherapy and Rehabilitation Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Songul Baglan Yentur

Elâzığ, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Songul Baglan Yentur

Role: primary

04242370000

Songul Baglan Yentur

Role: backup

Other Identifiers

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2024/06-40

Identifier Type: -

Identifier Source: org_study_id

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