Effectiveness Of Alcohol Addition In Ultrasound-Guided Periarticular Sacroiliac Joint Injection: A Double Blinded Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pain relief as measured by the visual analogue scale VAS scale
研究概览
简要总结
The aim of this work is to evaluate the efficacy of adding alcohol to local anesthetics and steroids to provide pain relief in patients with sacroiliac joint pain.
详细描述
Low back pain (LBP) is one of the most common health problems globally. According to the Global Burden of Disease (GBD) Study 2021, low back pain is the leading cause of years lived with disability worldwide. It affects approximately 619 million people globally, and this number is projected to increase to 843 million by 2050 due to population growth and aging. (1) LBP may arise from multiple anatomical structures, such as muscle, intervertebral disc, fascia, and facet joint. Another common cause of LBP includes the sacroiliac joint (SIJ). It is estimated that around 10-38% of LBP cases originated from the SIJ. (2) In addition to its prevalence, SIJ pain lacks valid clinical/diagnostic tests and no therapeutic modalities for long-term improvement have been found yet. (3) Treatment of SIJ pain is another dilemma, and a wide range of therapeutic modalities has been used, including pharmacotherapy, chiropractic manipulation, SIJ injection (local anesthetics, steroid, or mixture), and surgical fixation. (4) Steroid and local anesthetic (LA) injections are widely used for managing SIJ pain, and evidence supports their effectiveness, particularly in the short to intermediate term but long-term benefit usually requires repeat injections or alternative treatments as radiofrequency or prolotherapy (5,6,7) Recently, alcohol neurolysis has gained popularity and become a well-established interventional technique in pain management, particularly for patients with chronic or cancer-related pain that is refractory to conventional therapies. (8)
Alcohol (Ethanol) in different concentrations (from 70% to 20%) has been used in different joints and pain syndromes such as trigeminal neuralgia, post-mastectomy pain syndrome, ankle pain from Morton neuroma and bursitis, and it proved its efficacy and safety. (9,10,11,12) Previous studies tried phenol injection in SIJ pain which acts nearly with the same mechanism of action as ethanol exerting a neurolytic effect through protein denaturation and nerve fiber destruction. Also proved its efficacy and safety. (13, 14) No previous studies used alcohol injection in SIJ.This study hypothesize that the use of alcohol (ethanol) 30% as an adjuvant to steroids and local anesthetics in SIJ as a novel approach may offer both short and long-term pain relief and reduce the frequency of repeated injections.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of either gender diagnosed with sacroiliac joint pain.
- •Patient aged 18-60 years old.
- •Patients with American Society of Anesthesiologists (ASA) physical status I-II.
- •Chronic pain at sacroiliac joint for more than 12 weeks.
排除标准
- •Patients with MRI confirmed other cause of Low back pain as (disc prolapse, spinal canal stenosis, etc.).
- •Patients without any positive provocative tests (FABER, Gaenslen's and Fortin's finger tests).
- •Patients had findings suggestive of another source of axial back pain.
- •Patients with symptoms radiating past the knee.
- •Patients with less than 5/5 strength in the lower extremity.
- •Patients with diminished reflexes.
- •Patients diagnosed with myelopathy, and positive neural tension signs including straight leg raise and/or slump test.
- •Obese patients (BMI ≥ 35 kg/m²).
- •Infection at the injection site.
- •Patients who have undergone previous spine or pelvic surgery.
- •Coagulation disorders as bleeding tendency and platelet dysfunction.
- •Allergy to local anesthetics.
- •Patients with mental disorders, as well as drug abuse.
- •Lumbar facet steroid injections within the past 12 months
研究组 & 干预措施
Active comparator group (group D)
receives a mixture of dexamethasone and lidocaine 2%
干预措施: sacroiliac joint injection (Procedure)
Experimental group (group A)
receives a mixture of alcohol 30%, dexamethasone and lidocaine 2%
干预措施: sacroiliac joint injection (Procedure)
结局指标
主要结局
Pain relief as measured by the visual analogue scale VAS scale
时间窗: preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection
Presented by a 10 cm horizontal line representing the patient's pain intensity. Zero represents "no pain" while the upper limit (10 cm) represents the "worst pain imaginable.
次要结局
- Oswestry Disability Index (ODI)(preoperative(baseline), immediate after injection, 4 weeks, 8 weeks, 4 months and 6 months after injection)
- Patient Satisfaction Score (PSS)(within 15 minutes after the procedure completion)
- Time to first postoperative analgesic dose(interval (in hours) for the first 48 hours)
- Cumulative Gabapentin consumption(1 week, 4 weeks, 8 weeks, 4 months and 6 months after injection.)
- Procedure discomfort(within 15 minutes after the procedure completion)
- Complications(six months after injection)
研究者
Maged Shawky Farhat Gergis
Doctor
Fayoum University
