The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain With or Without Radiation to Lower Limbs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Roland Morris questionnaire
研究概览
简要总结
The primary focus of this study is to know the influence of sacroiliac joint manipulation on low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint
详细描述
One of the main problems faced by physiotherapists in primary care is low back pain with or without radiation to lower limbs. Nowadays, there are a lot of types of low back pain interventions, yet despite the vast amount of research findings, the evidence remains contradictory and inconclusive: Pharmacological treatments like NSAIDs have shown result in acute low back pain but not in chronic pain; conservative interventions (ultrasound, interferential currents, mechanical traction and massage) have been studied and found ineffective.
A total of 151 low back pain patients with or without radiation to lower limbs between 18-70 years old derived from the Physiotherapy Unit of Gévora Health Center (Badajoz, Spain) voluntarily entered the study
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
- None
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
- 是
入选标准
- •dysfunction or sacroiliac joint hypomobility (SI)
- •having stopped taking anti-inflammatory medicines or analgesics three days before the study began
排除标准
- •destructive injuries of the spine and pelvis
- •fractures
- •lumbar surgery
- •sacroiliac instability
- •spondylolisthesis
- •pregnancy in progress
- •cauda equina syndrome
- •abdominal aneurysm
- •infection
- •inflammatory arthritis
- •osteoporosis
研究组 & 干预措施
manipulation group (MG)
Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks
干预措施: manipulation group (MG) (Other)
electrotherapy group (EG)
Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions of electrotherapy).
干预措施: electrotheraphy group (EG) (Other)
结局指标
主要结局
Roland Morris questionnaire
时间窗: 1 week
disability assessment The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
digital algometer (Wagner, FPIX model)
时间窗: 1 week
Pain threshold assessment by pressing the sensitive points of the muscle
visual analogue scale (VAS)
时间窗: 1 week
Pain assessment from 0 to 10. 0: no pain 10: maximum pain
Oswestry disability index (ODI)
时间窗: 1 week
disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):
次要结局
未报告次要终点
研究者
Alejandro Caña Pino
Principal Investigator. Medical Surgical-Therapy Department, Universidad de Extremadura Facultad de Medicina, Badajoz, Spain
University of Extremadura