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NCT Number: NCT06237634

Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital, Kayseri, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

splint and exercise and advices

Other

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

Triamsinolon Asetonid ozone

Other

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

Ozone

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.

Primary outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire

    Time frame: at baseline, week 6, week 12

    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

Secondary outcomes

  1. VAS

    Time frame: at baseline, week 6, week 12

    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.

  2. ultrasound measurements

    Time frame: at baseline, week 6, week 12

    median nerve diameter measurement

  3. EMG measurements

    Time frame: at baseline, week 6, week 12

    median nerve latancy,amplitud, velocity measurements

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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