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临床试验/NCT05792111
NCT05792111招募中4 期

Analgesic Effects of Trigger Point Injection Added to Caudal Epidural Steroid

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年10月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
72
试验地点
1
主要终点
Numerical Rating Scale (NRS) score

研究概览

简要总结

This prospective randomized study will be conducted in Bolu Abant İzzet Baysal University Hospital. Chronic low back and hip pain 72 patients aged between 18-70 years will be included in the study. The primary output of our study was NRS scores. The study of Manchikanti. L et al. (control group NRS reduction 4.4 ± 1.8; α margin of error 0.05, power 99%) (3) was taken as the basis for determining the sample size. Using the G Power 3 calculator program, 72 patients were identified to reduce their NRS scores by 25%. With a 20% exclusion rate, the total number of patients was calculated as 90

详细描述

Demographic information of all patients included in the study; name, surname, telephone number, age, gender, educational status, profession, and marital status will be recorded. The duration of the pain, the onset of the pain, the accompanying leg pain, the activities that increase or decrease the pain, the presence of neurological symptoms, the analgesic agents used in the last week, and the previous treatments will be noted. Lumbar MRI findings and the level of pathology causing low back and hip pain will be recorded. History, family history, comorbidities (hypertension, diabetes mellitus, hyperlipidemia, cardiac disease, hypothyroidism), and detailed physical examinations of the patients will be recorded. Examinations of the patients before and 3, 6, and 12 weeks after the injection will be performed, and NRS scores at 3 and 6 weeks. The procedures will be repeated for patients who are over 4 years old. During the pre-procedural evaluation, the patients will be informed about the study, information about the Numeric Rating Score (NRS), Oswestry Disability Index (ODI), Short Form-36 (SF-36) to be used for post-procedure analgesia, and both verbal and written consents will be obtained. The staff who will make the evaluation will not know which group the patients belong to, and the study will be blinded.

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 (Investigator)

盲法说明

The staff who will evaluate the patient before and after the procedure will not know which group the patients belong to, and the study will be blinded.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Low back or leg pain that has been going on for at least 2 months,
  • Patients between the ages of 18-70,
  • Disc herniation or radiculopathy in lumbar MRI examination .To be mentally competent to understand and evaluate NRS, ODI, and SF-36 forms.
  • exclusion criteria
  • Being pregnant or lactating,
  • Presence of spinal canal stenosis,
  • The presence of bleeding diathesis,
  • Presence of disease with progressive neurological deficit,
  • The presence of serious psychiatric illness,
  • Presence of progressive neurological deficit or incontinence,
  • Having an epidural steroid injection in the last 6 months, Having uncontrolled diabetes mellitus Having hypertension,
  • Known history of allergy to local anesthetics or corticosteroids,
  • The patient does not want treatment,
  • Local infection at the injection site,
  • Infections such as discitis, spondylodiscitis, and sacroiliitis.

排除标准

  • 未提供

研究组 & 干预措施

Group C

Experimental

Group C; caudal epidural steroid injection (10 mL volume of bupivacaine 4cc/20mg+ triamcinolone 2cc/80mg+0.09% NaCl 4cc mixture will be administered into the caudal epidural space).

干预措施: Caudal epidural Group (bupivacaine + triamcinolone + NaCl) (Drug)

Group CT

Active Comparator

Group CT; trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.

干预措施: Trigger point injection (lidocaine) (Drug)

Group CT

Active Comparator

Group CT; trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.

干预措施: Caudal epidural Group (bupivacaine + triamcinolone + NaCl) (Drug)

结局指标

主要结局

Numerical Rating Scale (NRS) score

时间窗: after ESİ12 weeks

NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain

次要结局

  • Oswestry Disability Index(after ESİ12 weeks)
  • Short Form-36(after ESİ12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat Bilgi

Prof.dr

Abant Izzet Baysal University

研究点 (1)

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