Improvement in Pain, Function and Quality of Life With a Protocolized Exercise Program Compared With Non-steroidal Anti-inflammatory Analgesics in Patients With Subacute Low Back Pain in Medellín, Colombia, 2009-2010
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale of Pain
研究概览
简要总结
Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.
详细描述
General Purpose To evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.
Specific Objectives
- To evaluate the efficacy of a protocolized exercise program in reducing low back pain.
- To evaluate the efficacy of a protocolized exercise program in improving the function.
- To compare the effects of both interventions on quality of life and work absenteeism in the two groups of patients.
- To compare the safety of both interventions.
- To estimate adherence and causes of non-adherence of patients to different treatments proposed.
- To compare in both groups the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain.
Null Hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm.
Alternative hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm.
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
- •Patients aged between 18 and 60 years old
- •Subacute low back pain -evolution time more than 4 weeks and less than 3 months.
- •That have social security system
- •Live in the metropolitan area
排除标准
- •Antecedents of spinal, pelvis or abdominal trauma
- •Diabetes mellitus
- •Steroids use
- •Men and Women over 60 years
- •Cauda equine syndrome
- •Women and men with osteoporosis or compression fractures
- •Suspicion of infection.
- •Insidious onset, constitutional symptoms
- •Intravenous drugs abuse
- •Immunosuppression or previous surgery
- •Rheumatic diseases
- •Urinary tract infections
- •Neurological symptoms in lower limbs
- •Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
- •Deformities in the spine (scoliosis greater than 15º)
- •History of peptic acid disease
- •Renal failure
- •Intake of anticoagulants or antiplatelet drugs
- •Allergy to NSAIDs.
研究组 & 干预措施
Excercise
One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
干预措施: Exercise program (Other)
NSAID
Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
干预措施: NSAID (Nonsteroidal anti-inflammatory drugs) (Drug)
结局指标
主要结局
Visual Analogue Scale of Pain
时间窗: 24 weeks
The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.
次要结局
- Missing Workdays(24 weeks)
- Medical Consultations.(24 weeks)
- Quality of Life, Bodily Pain(24 weeks)
- Quality of Life, Emotional Performance.(24 weeks)
- Oswestry Disability Index(24 weeks)
- Roland-Morris Questionnaire(24 weeks)
- Quality of Life, Physical Function.(24 weeks)
- Quality of Life, Change in Health(24 weeks)
- Quality of Life, Physical Performance.(24 weeks)
- Quality of Life, Social Function.(24 weeks)
- Quality of Life, General Health Perceptions.(24 weeks)
- Quality of Life, Mental Health.(24 weeks)
- Relapses of Lumbar Pain(24 weeks)
- Treatments Associated With Low Back Pain at 6 Months(6 months)
- Quality of Life, Vitality.(24 weeks)
- PHQ-9 Patient Health Questionnaire (PHQ-9) Depression(24 weeks)
研究者
Fabio Alonso Salinas Duran
Associate Professor
Grupo Rehabilitacion en Salud