Clinical trial NCT06237634: Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome
Official title: Comparison Of The Effectiveness Of Ultrasound Acrossed Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: ozone injection
corticosteroid injection
carpal tunnel sendromu
ultrasound guided injection
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: at baseline, week 6, week 12
Secondary outcomes:
measure: VAS
timeFrame: at baseline, week 6, week 12
measure: ultrasound measurements
timeFrame: at baseline, week 6, week 12
measure: EMG measurements
timeFrame: at baseline, week 6, week 12
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: health sciences university Kayseri medicine faculty
city: Kayseri
country: Turkey
facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
Study officials:
affiliation: Kayseri City Hospital
name: HAVVA TALAY CALIS, PROF. DR
role: PRINCIPAL_INVESTIGATOR
References: