General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP: A Crossover Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain intensity via numeric pain rating scale
研究概览
简要总结
PURPOSE: To evaluate the effectiveness of adding transversus abdominis contraction to general exercises to treat patients with nonspecific acute low back pain.
BACKGROUND: Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable; thus, many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. Motor control exercises, which advocate the contraction of the TrA have shown some efficacy for patients with chronic low back pain. However, the validity of this strategy for patients with acute LBP is unclear.
HYPOTHESES: there will be no significant effect of adding transversus abdominis contraction to general exercise than general exercise alone in patients with non-specific acute low back pain.
RESEARCH QUESTION: Is there a statistically significant effect of adding transversus abdominis contraction to general exercise on outcomes of patients with non-specific acute low back pain?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes
- •Aged between 18 and 50 years
- •Acute nonspecific low back pain according to The most recent guidelines for the diagnosis and management of NSLBP come from the American College of Physicians and were published in
- •According to these guidelines, the diagnosis of acute NSLBP should be made based on the following criteria:
- •Acute onset of low back pain, defined as pain lasting for less than 12 weeks No specific identifiable cause of the pain (e.g., infection, malignancy, fracture, inflammatory disorder) No radicular symptoms (e.g., pain radiating down the leg) No significant neurological deficits or findings on physical examination (e.g., loss of reflexes or muscle strength)
排除标准
- •Serious low back pathology
- •Contraindications to exercise therapy
- •Neurological signs (leg weakness)
- •Specific spinal pathology (e.g., malignancy, or inflammatory joint or bone disease)
- •Prior back surgery
结局指标
主要结局
Pain intensity via numeric pain rating scale
时间窗: Changes in pain intensity at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
The primary outcome measure is pain intensity, which will be assessed using a numeric pain rating scale. Participants will be asked to rate their pain intensity on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Pain intensity will be measured at four time points: baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge. The change in pain intensity from baseline to each follow-up time point will be analyzed using appropriate statistical methods. The primary objective of the study is to determine whether the Back to Fitness Program is effective in reducing pain intensity over time.
次要结局
- Global Perception Effect(changes in Global perception at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.)
- Pain Pressure Threshold(Changes at Pain pressure threshold at baseline, 10 weeks after randomization, 3 and 6 months after discharge.)
- Disability(Changes in Disability at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.)
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University