Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Comparison Of The Effectiveness Of Ultrasound Acrossed Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06237634
• Other study ID #: Kayseri CH
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: January 2024
• Source: Kayseri City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 15, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• splint and exercise and advices
A hand-wrist support splint and tendon shifting exercises were applied to the upper extremity of the affected side.
• Triamsinolon Asetonid ozone
40 mg (1 ml) of triamcinolone acetonide was injected to the median nerve's around at wrist level under ultrasound guidance.
• 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.

Locations

Country	Name	City	State
Turkey	health sciences university Kayseri medicine faculty	Kayseri
Turkey	Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Carpal Tunnel Syndrome Questionnaire	The BCTQ comprises two subscales. The Symptom Severity Scale yields PRO data on the level of symptoms, while the Functional Status Scale assesses the level of hand function. The Symptom Severity Scale consists of 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms, and difficulty of grasping. The Functional Status Scale contains eight items, which assess functional deficits in the following domains: writing, buttoning clothes, holding a book while reading, gripping a telephone handle, opening jars, performing household chores, carrying grocery bags, bathing and dressing. Each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function. A Finnish version of the BCTQ, which was used in this study, has been previously validated	at baseline, week 6, week 12
Secondary	VAS	Visual analog scale A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.; Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	at baseline, week 6, week 12
Secondary	ultrasound measurements	median nerve diameter measurement	at baseline, week 6, week 12
Secondary	EMG measurements	median nerve latancy,amplitud, velocity measurements	at baseline, week 6, week 12