A Prospective, Randomized, Controlled, Single Centre Trial to Assess the Efficacy and Safety of Radial Extracorporeal Shock Wave Therapy in Patients With Chronic Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Pain Self-Efficacy Questionnaire (PSEQ) score (Nicholas, 1989; paper presented at the annual conference of the British Psychological Society, St. Andrews, 1989)
研究概览
简要总结
This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) in combination with the non-steroidal anti-inflammatory drug Celecoxib and the antispasmodic drug Eperisone (hereafter, "C-E drug therapy") is statistically significantly more effective than either rESWT or C-E drug therapy alone in the treatment of chronic non-specific low back pain.
详细描述
Non-specific low back pain is defined as low back pain not attributable to a recognizable, known specific pathology (e.g., infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome). It is second only to the common cold as the most common affliction of mankind and is among the leading complaints bringing patients to physicians' offices. The reported point prevalence of non-specific low back pain is as high as 33 percent, its one-year prevalence as high as 73 percent and its lifetime prevalence exceeds 70% in most industrialized countries, with an annual incidence of 15% to 20% in the United States of America. In physically active adults not seeking medical attention, the annual incidence of clinically significant non-specific low back pain with functional impairment is approximately 10 to 15 percent. In China, non-specific low back pain has become one of the leading causes of disability-adjusted life-years (DALYs) in 2010. Some authors reported the prevalence of non-specific low back pain as 41% in Chinese adolescents.
Management for patients with non-specific low back pain is challenged by the problems that most back pain has no recognizable cause (>85%), an underlying systemic disease is rare, and most episodes of back pain are unpreventable.
Acute non-specific low back pain (lasting three to six weeks) usually resolves in several weeks, although recurrences are common and low-grade symptoms are often present years after an initial episode. Risk factors for the development of disabling chronic or persistent non-specific low back pain (variously defined as lasting more than three months or more than six months) include preexisting psychological distress, disputed compensation issues, other types of chronic pain, and job dissatisfaction.
The goals of management for patients with non-specific low back pain are to decrease the pain, restore mobility, hasten recovery so the patient can resume normal daily activities as soon as possible, (iv) prevent development of a chronic recurrent condition, and restore and preserve physical and financial independence and comfort.
Unfortunately, few if any treatments have been proven effective for non-specific low back pain in meta-analyses, including limited bed rest, physical activity and exercise, back schools, traction, massage, chiropractic, radiofrequency denervation, paracetamol, opioids and, ultimately, surgery (in cases of cauda equina syndrome, infections, tumors and fractures compressing the spinal cord, mechanical instability of the back, and, perhaps, intractable pain with a positive straight-leg-raising test and no response to conservative therapy). Earlier studies demonstrated that muscle relaxants are effective in the management of non-specific low back pain, but the adverse effects require that they be used with caution. Accordingly, the aforementioned guideline by the American College of Physicians is only based on low- and moderate-quality evidence.
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
- Single (Outcomes Assessor)
盲法说明
A medical assistant at the Department of Pain Medicine at the First Affiliated Hospital of Zhejiang University will allocate interventions by means of opaque sealed envelopes that will be marked according to the allocation schedule. The medical assistant will be unaware of the size of the blocks.
The randomized intervention assignment as outlined above will be concealed from both patients and health care staff until recruitment will be complete and irrevocable.
Neither patients nor therapists will be blinded in the proposed study. The therapist will be the person who will administer rEWST to the patient.
The assessor will be blinded in the proposed study. The assessor is the person who will assess treatment success during follow up.
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (both male and female) with non-specific low back pain for more than three months.
- •Age range: between 18 and 80 years.
- •Willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient.
- •Chronic non-specific low back pain clinically diagnosed as repeated lumbar sourness and swelling pain or a chronic progressive process, accompanied by (i) X-ray examination to exclude lumbar vertebrate fractures, spondylolysis, spondylolisthesis and severe osteoporosis, and/or (ii) MRI with normal signal or low nucleus pulposus signal.
- •No contraindications for rESWT.
排除标准
- •Children and teenagers below the age of
- •Elderly aged >80 years old
- •No willingness of the patient to participate in the study, and/or written informed consent not signed and not personally dated by the patient.
- •Previous spinal fracture or spinal surgery.
- •Protrusion of a lumbar intervertebral disk, ankylosing spondylitis, scoliosis, lumbar spondylolisthesis and lumbar spondylolysis.
- •Systemic disorders and psychiatric disorders.
- •Contraindications of C-E drug treatment (treatment of patients allergy to celecoxib, eperisone or sulfonamides, patients with gastrointestinal bleeding or bleeding history, patients with renal dysfunction, patients with severe heart failure, and lactating women).
- •Contraindications of rESWT ( pregnant patients, patients with blood-clotting disorders [including local thrombosis], patients treated with oral anticoagulants, patients with local tumors, patients with local bacterial and/or viral infections [including lumbar vertebral tuberculosis], and patients treated with local corticosteroid applications in the time period of six weeks before the first rESWT session [if applicable]).
- •Participation in any other clinical trial in the time period of 12 weeks before potential inclusion in the proposed study.
研究组 & 干预措施
rESWT plus C-E drugs
Patients will receive rESWT, Celecoxib and Eperisone
干预措施: rESWT (Device)
rESWT plus C-E drugs
Patients will receive rESWT, Celecoxib and Eperisone
干预措施: Celecoxib (Drug)
rESWT plus C-E drugs
Patients will receive rESWT, Celecoxib and Eperisone
干预措施: Eperisone (Drug)
rESWT alone
Patients will receive rESWT
干预措施: rESWT (Device)
C-E drugs alone
Patients will receive Celecoxib and Eperisone
干预措施: Celecoxib (Drug)
C-E drugs alone
Patients will receive Celecoxib and Eperisone
干预措施: Eperisone (Drug)
结局指标
主要结局
Change in Pain Self-Efficacy Questionnaire (PSEQ) score (Nicholas, 1989; paper presented at the annual conference of the British Psychological Society, St. Andrews, 1989)
时间窗: Change from baseline PSEQ score at 12 weeks
Patients will be asked to rate how confident they are at the time of examination despite the presence of their pain in performing the following activities: * I can enjoy things, despite the pain. * I can do most of the household chores (e.g. tidying-up, washing dishes, etc.), despite the pain. * I can socialize with my friends or family members as often as I used to do, despite the pain. * I can cope with my pain in most situations. * I can do some form of work, despite the pain. * I can still do many of the things I enjoy doing, such as hobbies or leisure activities, despite the pain. * I can cope with my pain without additional medication (next to rESWT plus C-E drugs, rESWT alone or C-E drugs alone, respectively). * I can still accomplish most of my goals in life, despite the pain. * I can live a normal lifestyle, despite the pain. * I can gradually become more active, despite the pain.
次要结局
- Change in Numerical Rating Scale (NRS) score(Change from baseline NRS score at 2 weeks, 4 weeks, 12 weeks and 24 weeks)
- Change in Oswestry Low Back Pain Disability Questionnaire (OLDPDQ) score(Change from baseline OLDPDQ score at 2 weeks, 4 weeks, 12 weeks and 24 weeks)
- Change in Patient Health Questionnaire 9 (PHQ-9) score(Change from baseline PHQ-9 score at 2 weeks, 4 weeks, 12 weeks and 24 weeks)
- Change in lumbar curvature measurements performed on lateral lumbosacral spine radiographs(Change from baseline at 12 weeks)
- Change in Pain Self-Efficacy Questionnaire (PSEQ) score (Nicholas, 1989)(Change from baseline PSEQ score at 2 weeks, 4 weeks and 24 weeks)
