Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome

NCT ID: NCT06237634

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-09-15

Brief Summary

There are a limited number of studies on the use of ozone in CTS.The aim of this clinical study is to compare the effectiveness of corticosteroid injections and ozone injections added to splint and exercise therapy in mild-moderate CTS patients..

106 patients included in the study were randomized and divided into three groups. During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.

Detailed Description

106 patients included in the study were randomized and divided into three groups.

During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.

Neutral hand-wrist rest splint and tendon-nerve gliding exercises were given to 30 patients included in the control group.

In addition to the treatment given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected under USG guidance to 30 patients included in the corticosteroid group.

In addition to splint and exercise therapy, 3 cc ozone (O2-O3), 10 micrograms were injected under USG guidance to 30 patients in the ozone group.

Patients in all three groups were evaluated at the beginning of treatment, 6 weeks and 3 months after treatment.

Evaluation methods include provocative tests (Tinnel, Phallen, Flick tests), visual analogue scale (VAS) numbness day/night and VAS pain scores, sensory tests (two-point discrimination and Semmes Weinstein monofilament test (SWMT)), hand and finger grip strengths. measurement, Boston carpal tunnel syndrome questionnaire (BCTA), median nerve cross-sectional area (MSCA) measurement with USG and electrophysiological parameters were used.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

First group (30 people): A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side..

Group Type: ACTIVE_COMPARATOR

splint and exercise and advices

Intervention Type: OTHER

A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.

corticosteroid group

Second group (30 people): In addition to the treatment and recommendations given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected into the wrist under ultrasound guidance.

Group Type: ACTIVE_COMPARATOR

splint and exercise and advices

Intervention Type: OTHER

A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.

Triamsinolon Asetonid ozone

Intervention Type: OTHER

40 mg (1 ml) of triamcinolone acetonide was injected to the median nerve's around at wrist level under ultrasound guidance.

ozone group

Third group (30 people): In addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml.

Group Type: EXPERIMENTAL

splint and exercise and advices

Intervention Type: OTHER

A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.

ozone

Intervention Type: OTHER

In addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml.

Interventions

splint and exercise and advices

A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.

Intervention Type: OTHER

Triamsinolon Asetonid ozone

40 mg (1 ml) of triamcinolone acetonide was injected to the median nerve's around at wrist level under ultrasound guidance.

Intervention Type: OTHER

ozone

In addition to the treatment and recommendations given to the first group, the affected side was injected with ultrasound-guided 3 cc ozone (O2-O3) into the wrist with a concentration of 10 micrograms/ml.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18-70, male or female.
• Clinically and electrophysiologically diagnosed with mild or moderate CTS
• Having symptoms for 1 month or longer
• No contraindications for corticosteroid and ozone application
• Patients whose consent was obtained to participate in the study

Exclusion Criteria

• Under 18 years old and over 70 years old
• Having a severe CTS
• Having thenar atrophy
• Those with diabetes, thyroid and kidney disease and CTS developing secondary to this
• Those with previous traumatic nerve injury, peripheral nerve injury or surgery
• Those with a diagnosis of polyneuropathy
• Having rheumatic disease
• With known radiculopathy
• are pregnant
• Known G6PD deficiency, hyperthyroidism, thrombocytopenia, severe cardiovascular instability
• Those who have infection, burns, cuts or skin integrity in the skin area to be treated
• Cognitive disorder, severe psychiatric illness
• Those with diabetes, thyroid and kidney disease and CTS developing secondary to this
• Patients who have not received corticosteroid or ozone injection in the last 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kayseri City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Havva Talay Calıs

Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HAVVA TALAY CALIS, PROF. DR

Role: PRINCIPAL_INVESTIGATOR

Kayseri City Hospital

Locations

health sciences university Kayseri medicine faculty

Kayseri, , Turkey (Türkiye)

Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Kayseri CH

Identifier Type: -

Identifier Source: org_study_id