A Pragmatic Randomised Controlled Trial of a Protocol of Evidence-Based Conservative Care Compared to Usual Chiropractic Care for Acute Non-Specific Low Back Pain – An Exploratory Pilot Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Acute non-specific low back pain; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12610000530022
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified