Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome

NCT06237634 | Completed

• 1 other identifier: Kayseri CH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• VAS

  at baseline, week 6, week 12

• ultrasound measurements

  at baseline, week 6, week 12

• EMG measurements

  at baseline, week 6, week 12

Study Arms (3)

control group

ACTIVE COMPARATOR

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

corticosteroid group

ACTIVE COMPARATOR

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; Other: Triamsinolon Asetonid ozone

ozone group

EXPERIMENTAL

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; Other: ozone

Interventions

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.

control group; corticosteroid group; ozone group

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.

corticosteroid group

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.

ozone group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (2)

health sciences university Kayseri medicine faculty

Kayseri, 38080, Turkey (Türkiye)

Location

Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Splints; Exercise; Counseling; Ozone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Oxygen; Gases; Inorganic Chemicals

Study Officials

• HAVVA TALAY CALIS, PROF. DR

  Kayseri City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: February 1, 2024
• Study Start: January 1, 2021
• Primary Completion: April 10, 2021
• Study Completion: September 15, 2021
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)