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Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06237634
Enrollment
90
Registered
2024-02-01
Start date
2021-01-01
Completion date
2021-09-15
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

ozone injection, corticosteroid injection, carpal tunnel sendromu, ultrasound guided injection

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.

Interventions

OTHERsplint and exercise and advices

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

OTHERTriamsinolon Asetonid ozone

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

OTHERozone

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.

Sponsors

Kayseri City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Boston Carpal Tunnel Syndrome Questionnaireat baseline, week 6, week 12The 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

Secondary

MeasureTime frameDescription
VASat baseline, week 6, week 12Visual 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.
ultrasound measurementsat baseline, week 6, week 12median nerve diameter measurement
EMG measurementsat baseline, week 6, week 12median nerve latancy,amplitud, velocity measurements

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026