Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Efficacy of intervention.
研究概览
简要总结
This study has the primary goal of evaluating the efficacy of corticoid infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration.
详细描述
This study has the primary goal of evaluating triamcinolone's efficacy on the ultrasound- guided infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration.
It is an interventional study, double-blinded and randomized, in a sample of patients followed in the Chronic Pain Unit (Hospital of Braga, Portugal), proposed for ultrasound infiltration of the quadratus lumborum muscle.
The selection of the patients will take into account the inclusion and exclusion criteria, until reach the required sample size (66 patients). The confirmation of the inclusion criteria will be done by a physiatrist blind to randomization.
Different protocols will be randomly applied to patients after obtaining written informed consent.
The techniques will be performed by two anesthetists. The data will be obtained through questionnaires filled out on the day of the technique and in the course of 1, 3 and 6 months in chronic pain consultation and by telephone call 72 hours after the procedure. It will be a psychologist, blind to randomization, to fill the questionnaires.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I) patients followed in the Chronic Pain Unit proposed to have ultrasound- guided infiltration of the quadratus lumborum muscle.
- •II) written informed consent.
- •III) presence of 4 of the following clinical criteria evaluated by a physiatrist:
- •pain below the 12th rib and 5 cm lateral to the transverse process of L1 during palpation, with referred pain to the iliac crest;
- •pain on palpation of the trigger points in the quadratus lumborum muscle;
- •exacerbation of the pain with with postural changes when lying down, walking, sitting and/or squatting;
- •lumbar pain with muscle stretching;
- •painful palpation of trigger points at the level of L4 vertebral body, 1 to 2 cm above the iliac crest.
排除标准
- •rheumatologic disease;
- •psychiatric disease;
- •neurological disease;
- •history of anticoagulation use;
- •pregnant patients;
- •uncontrolled diabetes mellitus;
- •patients on corticosteroid therapy;
- •allergy to the medication to be used;
- •anterior realization of ultrasound techniques for low back pain ;
- •anterior realization, of invasive techniques, less than 6 months, with administration of medication.
研究组 & 干预措施
Quadratus triamcinolone
Quadratus lumborum muscle and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
干预措施: Quadratus triamcinolone (Drug)
Gluteus triamcinolone
Gluteus maximus and fascia infiltration with 40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
干预措施: Gluteus triamcinolone (Drug)
Quadratus without triamcinolone
Quadratus lumborum muscle and fascia infiltration with 10ml of levobupivacaine 0,25%.
干预措施: quadratus without triamcinolone. (Drug)
结局指标
主要结局
Efficacy of intervention.
时间窗: 3 months after intervention.
Evaluation of pain score using numerical rating scale (NRS), represented 0 with no pain and 10 with the worst pain imaginable. It will be evaluated the actual, average and worst intensity of pain. Efficacy of the procedure will be defined as greater or equal to 30% pain relief lasting at least 3 months.
次要结局
- Pain evaluation(6 months after intervention.)
- Quality of life.(6 months after intervention.)
- Psychological status.(6 months after intervention.)
- Complications and adverse effects caused by the intervention.(72 hours after intervention.)
- Opioid consumption.(6 months after intervention.)