Comparison Of The Effectiveness Of Ultrasound Acrossed Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Boston Carpal Tunnel Syndrome Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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..
干预措施: splint and exercise and advices (Other)
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.
干预措施: splint and exercise and advices (Other)
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.
干预措施: Triamsinolon Asetonid ozone (Other)
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.
干预措施: splint and exercise and advices (Other)
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.
干预措施: ozone (Other)
结局指标
主要结局
Boston Carpal Tunnel Syndrome Questionnaire
时间窗: 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
次要结局
- ultrasound measurements(at baseline, week 6, week 12)
- VAS(at baseline, week 6, week 12)
- EMG measurements(at baseline, week 6, week 12)
研究者
Havva Talay Calıs
Prof.Dr.
Kayseri City Hospital