Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome

January 24, 2024 updated by: Havva Talay Çalış, Kayseri City Hospital

Comparison Of The Effectiveness Of Ultrasound Acrossed 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38080
        • health sciences university Kayseri medicine faculty
      • Kayseri, Turkey, 38080
        • Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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..
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.
Active Comparator: 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.
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.
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.
Experimental: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline, week 6, week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline, week 6, week 12
ultrasound measurements
Time Frame: at baseline, week 6, week 12
median nerve diameter measurement
at baseline, week 6, week 12
EMG measurements
Time Frame: at baseline, week 6, week 12
median nerve latancy,amplitud, velocity measurements
at baseline, week 6, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri City Hospital

Investigators

  • Principal Investigator: HAVVA TALAY CALIS, PROF. DR, Kayseri City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

April 10, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kayseri CH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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