ACTRN12610000530022已完成未知
In patients with acute non-specific low back pain, is an evidence-based protocol of conservative care more effective than usual chiropractic care in improving low back-related pain and disability?
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Potentially eligible participants were those who:
- •a. Presented with Low Back Pain (LBP) with or without leg pain;
- •b. Had not previously received chiropractic treatment;
- •c. Had not received any treatment for their current episode of Low Back Pain (LBP) or LBP in the last three months;
- •d. Were at least 18 years old, but not older than 60 years; and
- •e. Did not to have any concomitant illness.
- •The key criteria for this diagnosis were (Cassidy et al. 2005; Waddell & Burton 2005; van Tulder et al. 2006):
- •1. Unilateral or bilateral LBP;
- •2. Discomfort and/or tenderness produced by joint challenge and/or joint compression in the low back;
- •3. LBP with or without leg pain, where the leg pain is not due to significant neurological or vascular deficit e.g. cauda equina syndrome, central canal stenosis, degenerative spondylolisthesis or degenerative/ osteophytic nerve root entrapment; and
- •4. Restriction of some or all of the active and/or passive range of motion of the low back.
- •The working diagnosis for each eligible patient would thus be in line with the definition of acute non-specific LBP (Bouter et al. 1998; de Vet et al. 2002; Koes et al. 2006; Kinkade 2007), defined as:
- •LBP of a non-specific (common) variety, of either first or recurrent nature (new episode after a pain free period), lasting more than twenty-four hours from onset, perpetuating for less than six weeks (acute), preceded by pain-free three-month period, characterised by pain below the costal margin and above the gluteal folds, with or without leg pain, amenable to treatment by a consultation or a series of consultations)
- •Inclusion Criteria
- •Potential subjects were included only if each subject:
- •1. Provided informed consent prior to entering the study;
- •2. Accepted the randomisation procedure;
- •3. Had the working diagnosis of non-specific acute episode LBP as described previously;
- •4. Experienced LBP for a period of less than 6 weeks;
- •5. Did not participate in or have an occupation that included vigorous activity or that may perpetuate, or even worsen, the existing problem (e.g. contact sport, heavy manual lifting);
- •6. Had an initial pain score of at least 35mm (35%) on a pain measurement scale (Ostelo & de Vet 2005; van de Roer et al. 2006); and
- •7. Had not received chiropractic care before.
排除标准
- •Exclusion Criteria
- •Patients were not eligible if (adapted from Underwood et al. 2004):
- •1. They were aged over 60 years, because the spinal manipulation package could be more hazardous in older people with osteoporosis;
- •2. There was a possibility of serious spinal disorder, including malignancy, osteoporosis, ankylosing spondylitis, cauda equina compression, and infection;
- •3. There were any contraindications to the treatment(s), such as acute arthropathies, joint/spinal instability, bone malignancies and metastases, infections of bone and joint, acute myelopathy, demineralization of bone (e.g., osteoporosis), benign bone tumors, abdominal aortic aneurysm, anticoagulant therapy, and blood dyscrasias;
- •4. They complained mainly of pain below the knee, as the clinical outcome was likely to be different;
- •5. They had previously had spinal surgery, as the clinical outcome was likely to be very different;
- •6. They had another musculoskeletal disorder that was more troublesome than their back pain;
- •7. They had previously attended, or been referred to, a specialised pain management clinic;
- •8. They had a severe psychiatric or psychological disorder;
- •9. They had another medical condition, such as cardiovascular disease, that could interfere with therapy;
- •10. They were taking anticoagulant treatment;
- •11. They were taking long term steroids, which might lead to osteoporosis;
- •12. They could not walk 100m when free of back pain, as keeping active could be difficult;
- •13. They could not get up from and down to the floor unaided by another person;
- •14. They had received physical therapy (including acupuncture) from another health care provider in the previous three months; and
- •15. They could not understand, read and write fluently in English.
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