None listed
Conditions
Brief summary
The purpose of this study was to test a protocol of evidence-based conservative care, acceptable to practicing chiropractors and feasible to implement in clinical practice, and compare it to usual chiropractic care in a pragmatic, pilot randomised controlled trial to determine the short-term effectiveness of this protocol of care. The goal was to provide insight into the possible effectiveness of the interventions tested and to inform the design of a future definitive clinical trial. The overall hypothesis was that there is no difference in effectiveness between usual chiropractic care and a protocol of evidence-based conservative care for acute non-specific low back pain in chiropractic practice, based on the primary and secondary outcomes.
Interventions
Protocol of Evidence-Based Conservative Care (Experiment):
Each participant was received up to 7 treatments of 15 minutes each over a 4-week treatment period. Treatment was provided by an experienced chiropractor of at least 5 years clinical experience.
The salient features of this protocol of care were: (a) Patient advice & education (education material and health promotion) using The Back Book only. No practitioner-specific or individualised education was permitted; (b) The patient participant
Protocol of Evidence-Based Conservative Care (Experiment): Each participant was received up to 7 treatments of 15 minutes each over a 4-week treatment period. Treatment was provided by an experienced chiropractor of at least 5 years clinical experience. The salient features of this protocol of care were: (a) Patient advice & education (education material and health promotion) using The Back Book only. No practitioner-specific or individualised education was permitted; (b) The patient participant was encouraged to remain active by their practitioner; (c) Regular use of spinal manipulation (manual, high velocity, low amplitude manipulation, excluding table- and instrument-assisted manipulation); and (d) The discretionary use of pre-manipulative joint mobilisation and gentle massage (a lubricant or cream that did not contain an active or pharmaceutical ingredient was permitted). Since pharmaceutical agents cannot be prescribed by musculoskeletal practitioners, like chiropractors, this treatment was not part of the protocol of care.
Sponsors
King's College London
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed