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Trial registered on ANZCTR


Registration number
ACTRN12610000530022
Ethics application status
Approved
Date submitted
24/06/2010
Date registered
30/06/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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?
Secondary ID [1] 252097 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute non-specific low back pain 257651 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257825 257825 0 0
Other physical medicine / rehabilitation
Musculoskeletal 257838 257838 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256722 0
Treatment: Other
Comparator / control treatment
Usual Chiropractic Care (Control):
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.
Usual chiropractic care is a package of treatment that routinely includes manual therapies, spinal manipulation, traditional chiropractic techniques, soft tissue (muscle) treatments, health promotion, exercise or rehabilitation therapy and patient education or advice. The combination of treatments is chosen at the discretion of the chiropractor, usually in collaboration with the patient.
Below are further descriptions of some of the treatments that a patient may have received as part of usual care:
(a) Spinal manipulation – a controlled thrust(s) applied to a joint or soft tissue by the practitioner (usually the high velocity, low amplitude thrust); (b) Manual and soft tissue therapy – joint mobilisation, massage, and/or muscular trigger point therapy; (c) Therapeutic exercise – specific exercise regimes to help the patient recover from their disorder; (d) Patient education, nutritional advice and health promotion – practical advice and guidance on lifestyle, exercise, nutrition, and health promotion to support recovery; and (e) Specific chiropractic treatments or technique systems – specific and/or “named” chiropractic techniques or technique systems.
Control group
Active

Outcomes
Primary outcome [1] 258685 0
Low back-related pain - Visual Analogue Scale
Timepoint [1] 258685 0
Baseline (week 0);
Midpoint of treatment period (end of week 2;
End of treatment period (end of week 4)
Primary outcome [2] 258686 0
Low back-related disability - Oswestry Low back Disability Index
Timepoint [2] 258686 0
Baseline (week 0);
Midpoint of treatment period (end of week 2;
End of treatment period (end of week 4)
Secondary outcome [1] 264707 0
Patient satisfaction - Patient Satisfaction Questionnaire
Timepoint [1] 264707 0
End of treatment period (end of week 4)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruited patient participants were those that were eligible for the study after screening and met the inclusion criteria for the study. All patients with LBP were screened, interviewed and examined by the participating chiropractors. Those patients that had a working diagnosis of acute non-specific LBP, determined by their respective chiropractor, were eligible for the study. Eligible patients were then informed of the study, provided with a study information sheet and invited to participate. Patients were informed of their right to withdraw from the study at any time, without notice, and that their withdrawal would not prejudice any further care. Eligible patients that volunteered for the study and provided informed consent to participate, were then randomly allocated to one of the intervention groups.
Random allocation was conducted using sealed opaque envelopes, thus allocation was consealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The primary researcher, who did not participate as a clinician in this study, performed the randomisation, using a random numbers process. Each random treatment assignment (initially 40 patients) was placed in a sealed envelope, producing a series of sequentially numbered, opaque sealed envelopes that were shared equally between the three practice sites. As each eligible patient was consented to participate, the practice co-ordinator then opened an envelope, in sequence, and identified the treatment group to which the participant was assigned.

The chiropractors providing treatment were consealed to the randomisation process, as were the clinic coordinators. Participating patients were not informed as to which group they were assigned, but were given the appropriate descriptions of the treatments they were to receive.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment outside Australia
Country [1] 2724 0
United Kingdom
State/province [1] 2724 0
Surrey
Country [2] 2725 0
United Kingdom
State/province [2] 2725 0
Wales

Funding & Sponsors
Funding source category [1] 257199 0
Self funded/Unfunded
Name [1] 257199 0
Gregory Parkin-Smith
Country [1] 257199 0
Australia
Primary sponsor type
University
Name
King's College London
Address
Strand
London WC2R 2LS
Country
United Kingdom
Secondary sponsor category [1] 256455 0
None
Name [1] 256455 0
Address [1] 256455 0
Country [1] 256455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259229 0
King's College Research Ethics Committee; Psychiatry, Nursing and Midwifery Research Ethics Subcommittee
Ethics committee address [1] 259229 0
Research Ethics Office
Room 7.21, JCMB
57 Waterloo Road
London SE1 8WA
Ethics committee country [1] 259229 0
United Kingdom
Date submitted for ethics approval [1] 259229 0
27/06/2008
Approval date [1] 259229 0
17/09/2008
Ethics approval number [1] 259229 0
PNM/07/08-56

Summary
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.
Trial website
None
Trial related presentations / publications
Platform presentation at the Chiropractic & Osteopathic College of Australiasia annual conference in Sydney, Australia, October 2009.
Public notes

Contacts
Principal investigator
Name 31336 0
Address 31336 0
Country 31336 0
Phone 31336 0
Fax 31336 0
Email 31336 0
Contact person for public queries
Name 14583 0
Gregory Parkin-Smith
Address 14583 0
School of Chiropractic & Sports Science
Murdoch University
South Street
Murdoch
WA, 6150
Country 14583 0
Australia
Phone 14583 0
+61 8 93601389
Fax 14583 0
Email 14583 0
[email protected]
Contact person for scientific queries
Name 5511 0
Gregory Parkin-Smith
Address 5511 0
School of Chiropractic & Sports Science
Murdoch University
South Street
Murdoch
WA, 6150
Country 5511 0
Australia
Phone 5511 0
+61 8 93601389
Fax 5511 0
Email 5511 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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