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Trial registered on ANZCTR


Registration number
ACTRN12609001022257
Ethics application status
Approved
Date submitted
20/11/2009
Date registered
25/11/2009
Date last updated
13/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving the care for people with acute low-back pain by allied health professionals: a cluster randomised controlled trial
Scientific title
The effect of a targeted, theory-based intervention designed to increase the uptake of recommendations from a clinical practice guideline for the management of acute musculoskeletal pain, compared to receiving the clinical practice guideline alone, on percentage of plain x-ray referral by chiropractors and physiotherapists for people with acute non-specific low-back pain.
Secondary ID [1] 1151 0
None
Universal Trial Number (UTN)
Trial acronym
ALIGN: Acute Low-back pain: Implementing Guidelines iNto practice
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute non-specific low-back pain 252247 0
Condition category
Condition code
Musculoskeletal 252434 252434 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating clinicians from practices randomised to the intervention arm will receive an implementation strategy, underpinned by behavioural theory, designed to address the modifiable barriers to implementing an evidence-based guideline for acute low back pain (LBP) by physiotherapists and chiropractors.
The intervention will be one full-day interactive workshop (8 hours duration) led by trained facilitators (practising clinicians and academic researchers) and a single follow-up telephone call 2-4 weeks after the workshop. The behaviour change techniques utilised in the workshop include: (a) social processes of encouragement, pressure and support; (b) persuasive communication; (c) information regarding behaviour and outcome; (d) feedback; (e) increasing skills, (f) rehearsal of relevant skills, (g) information provision; (h) prompts, triggers and cues; and (i) action planning and self monitoring.
Intervention code [1] 241581 0
Behaviour
Comparator / control treatment
Standard treatment/care: Participating clinicians from practices randomised to the comparator treatment will receive a hard copy of the National Health and Medical Research Council (NHMRC)-endorsed ‘Evidence-based management of acute musculoskeletal pain’ clinical practice guideline in the mail and a written reminder of how to access the electronic copy of the guideline.
Control group
Active

Outcomes
Primary outcome [1] 253311 0
X-ray referral (measured via practitioner-reported encounter forms with consecutive patients who have acute non-specific low back pain)
Timepoint [1] 253311 0
Encounter forms are completed immediately following patient consultations during a two-week data collection period. Data collection period occurs 3-4 months after intervention delivery.
Primary outcome [2] 262239 0
Low-back pain specific disability (measured via Roland-Morris Disability Questionnaire [Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine 1983;8:141-4])
Timepoint [2] 262239 0
Questionnaires will be completed by patients 3 months post-onset of acute low-back pain episode
Secondary outcome [1] 262357 0
Advice to stay active (measured via practitioner-reported encounter forms with consecutive patients who have acute non-specific low back pain)
Timepoint [1] 262357 0
Encounter forms are completed immediately following patient consultations during a two-week data collection period. Data collection period occurs 3-4 months after intervention delivery.
Secondary outcome [2] 262358 0
Advised bed rest (measured via practitioner-reported encounter forms with consecutive patients who have acute non-specific low back pain)
Timepoint [2] 262358 0
Encounter forms are completed immediately following patient consultations during a two-week data collection period. Data collection period occurs 3-4 months after intervention delivery.
Secondary outcome [3] 262359 0
Any imaging referral (measured via practitioner-reported encounter forms with consecutive patients who have acute non-specific low back pain)
Timepoint [3] 262359 0
Encounter forms are completed immediately following patient consultations during a two-week data collection period. Data collection period occurs 3-4 months after intervention delivery.
Secondary outcome [4] 262360 0
Practitioner behavioural constructs (attitudes, beliefs and intentions) measured via questionnaire
Timepoint [4] 262360 0
At baseline and 4 months following intervention/control delivery.
Secondary outcome [5] 262361 0
Practitioner fear avoidance beliefs (measured via questionnaire)
Timepoint [5] 262361 0
At baseline and 4 months following intervention/control delivery.
Secondary outcome [6] 262363 0
Patient usual pain (measured via questionnaire using an 11-point numerical rating scale (0-10))
Timepoint [6] 262363 0
At 3 months after onset of acute low-back pain episode.
Secondary outcome [7] 262364 0
Patient reports referral for an x-ray or received an x-ray from their chiropractor or physiotherapist for the current episode of low-back pain (measured via questionnaire)
Timepoint [7] 262364 0
At 3 months after onset of acute low-back pain episode.
Secondary outcome [8] 262365 0
Patient fear avoidance beliefs (measured via Fear Avoidance Beliefs Questionnaire [Waddell G, Newton M, Henderson I, et al. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain 1993;52:157-68])
Timepoint [8] 262365 0
At 3 months after onset of acute low-back pain episode.
Secondary outcome [9] 262366 0
Patient quality of life (measured via Assessment of Quality of Life Questionnaire [Hawthorne G, Richardson J & Osborne R. The assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Quality of Life Research 1999;8:209-224])
Timepoint [9] 262366 0
At 3 months after onset of acute low-back pain episode.
Secondary outcome [10] 262367 0
Health service utilisation used by patient (measured via Health Service Utilisation items in questionnaire)
Timepoint [10] 262367 0
At 3 months after onset of acute low-back pain episode.
Secondary outcome [11] 273369 0
X-ray referral (measured via files of consecutive patients who have acute non-specific low back pain who consent to file audit).
Timepoint [11] 273369 0
Audit of patient files will be done at 7 months following intervention/control delivery.
Secondary outcome [12] 273370 0
Imaging referral excluding x-ray (measured via files of consecutive patients who have acute non-specific low back pain who consent to file audit).
Timepoint [12] 273370 0
Audit of patient files will be done at 7 months following intervention/control delivery.

Eligibility
Key inclusion criteria
Practices will be eligible for inclusion in the trial if (i) at least one chiropractor or physiotherapist provides written informed consent, (ii) the practice principal agrees to the practitioner/practice being involved in the cluster randomised controlled trial (C-RCT), (iii) the practice manager, where applicable, agrees to the practice being involved in the C-RCT, (iii) practice staff are willing to facilitate patient recruitment.

Patient participants will be eligible for inclusion if (i) they attend a participating practice for acute non-specific LBP (duration of less than three months), (ii) provide written informed consent, (iii) are at least 18 years old, (iv) are able to write and understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Practices will be ineligible for inclusion in the trial if any of the chiropractors or physiotherapists at the practice are involved in the study Advisory Committee or have participated in Phase 1 interviews for the study.

Patient participants will be ineligible for inclusion in the trial if (i) they are less than 18 years of age, (ii) are not able to give informed consent, (iii) the current episode of LBP has been present for more than three months. (iv) radicular leg pain is present, (v) they have had previous spinal surgery, (vi) “red flags” are present alerting the possibility of serious conditions such as malignancy, infection or fracture, (vii) they are pregnant, (viii) they do not speak English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Practices meeting the inclusion criteria will be randomly allocated to receive either the intervention or control. Restricted randomisation will be used to reduce the probability of baseline imbalance. Within stratum, one-half of the practices will be randomised to the intervention group, and the other half to the control using computer-generated random numbers. Two strata will be defined: type of practice (physiotherapy or chiropractic) and location of practice (rural or metropolitan). A statistician independent of the study will implement the randomisation. They will be provided with only practice codes and stratification variables. Randomisation of practices will be undertaken at one time. Allocation will be concealed from the investigators until baseline data has been collected from practitioners.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number will be generated using the statistical package Stata/MP 10.1 for Windows (StataCorp. 2007. Stata Statistical Software: Release 10. College Station, TX: StataCorp LP). Within stratum, practices will be sorted by the random number. The first half of the practices within each stratum will be allocated to the intervention, and the second half to the control.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244060 0
Government body
Name [1] 244060 0
National Health and Medical Research Council
Country [1] 244060 0
Australia
Primary sponsor type
University
Name
School of Public Health and Preventive Medicine
Address
Level 6, The Alfred Centre, 99 Commercial Road, Melbourne VIC 3004, Australia
Country
Australia
Secondary sponsor category [1] 251406 0
None
Name [1] 251406 0
Address [1] 251406 0
Country [1] 251406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258155 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 258155 0
Human Ethics, Monash Research Office, Building 3E, Room 111, Monash University, Clayton 3800
Ethics committee country [1] 258155 0
Australia
Date submitted for ethics approval [1] 258155 0
Approval date [1] 258155 0
04/11/2009
Ethics approval number [1] 258155 0
CF07/1060; CF09/1956

Summary
Brief summary
Little is known about ways to promote informed and effective treatment by providers other than medical practitioners. Expanding evidence demonstrates that interventions to change practice should be targeted at specific clinical behaviours and underpinned by appropriate behavioural theory. Existing research into behavioural change in medical practitioners may not be generalisable to other professionals. Acute low back pain (LBP) is common and chiropractors and physiotherapists provide most care for the condition in Australia. The NHMRC clinical practice guidelines (CPGs) for acute LBP provides recommendations with potential to improve quality of care and safety for people with LBP. Relevant CPG recommendations are that x-rays are rarely needed and that patients should be advised to remain active. We are currently investigating the effectiveness of a targeted, theory-based implementation strategy to implement CPGs in general practice (NHMRC project grant 334060). Whether implementation strategies are transferable between professional groups is not known. This project allows us to build on our completed work to date, incorporating qualitative interviews and surveys of physiotherapists and chiropractors to explore barriers and enablers to CPG uptake (NHMRC project grant 436767) in order to develop a targeted implementation strategy for use in physiotherapy and chiropractic clinics.
A cluster randomised controlled trial will then be conducted to determine the effects of the strategy. Practices (n=136) will be randomised to receive either the developed implementation strategy, including strategies targeted at clinicians and patients, or to a control group receiving access to the CPG alone. We plan to recruit 2720 patients from the 136 practices. The outcomes of the implementation strategy will be assessed at the level of the practitioner (did the strategy result in a change of practice?) and the patient (did the practice change result in improved patient outcomes?). Subgroup analyses will investigate effects specific to chiropractors and physiotherapists.
Trial website
http://www.cochrane.org.au/projects/allied_health.php
Trial related presentations / publications
McKenzie JE, O’Connor DA, Page MJ, Mortimer DS, French SD, Walker BF, Keating JL, Grimshaw JM, Michie S, Francis JJ, Green SE. Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): cluster randomised trial protocol. Implementation Science 2010;5:86.

Green S, Lawrence A, O’Connor D, McKenzie J, Murphy K, Page M, Beringer K, Walker B, Keating J, French S, Michie S, Francis J, Grimshaw J, Mortimer D, on behalf of the ALIGN study investigators and advisory committee. Management of acute low-back pain in chiropractic and physiotherapy practice: Improving care by increasing uptake of evidence-based guidelines; an overview of the ALIGN cluster randomised controlled trial. Oral presentations at the Chiropractors’ Association of Australia Scientific Symposium, 22 November 2009, Melbourne, Australia.

B Walker, D O’Connor, J McKenzie, K Murphy, M Page, K Beringer, J Keating, S French, S Michie, J Francis, J Grimshaw, D Mortimer, S Green, on behalf of the ALIGN study team. Improving acute low-back pain management in chiropractic and physiotherapy practice by enhancing uptake of an evidence-based guideline: the ALIGN cluster randomised controlled trial. Oral presentation at the Chiropractic & Osteopathic College of Australasia’s 8th Biennial Conference, 20-22 November 2009, Sydney, Australia.

O’Connor D, Murphy K, Page M, Beringer K, French S, McKenzie J, Keating J, Walker B, Grimshaw J, Michie S, Francis J, Green S. Uncovering the factors influencing use of evidence-based guidelines for acute low-back pain in primary care: a theory-informed, mixed methods approach used in the ALIGN study. Oral presentation at the General Practice and Primary Health Care Conference, 15-17 July 2009, Melbourne, Australia.

O'Connor D, Murphy K, French S, McKenzie J, Keating J, Walker B, Grimshaw J, Michie S, Francis J, Page M, Beringer K, Green S. Use of theory to identify and address barriers and enablers to uptake of evidence-based guidelines for
acute low-back pain by Australian physiotherapists and chiropractors: Phase 1 of the ALIGN project. Poster presentation at the Low Back Pain Primary Care Forum, 14-17 June 2009, Boston, United States of America.

O’Connor D, Murphy K, Green S, French S, McKenzie J, Walker B, Keating J, Grimshaw J, Michie S, Francis J, Mortimer D, and the ALIGN Study Group. The ALIGN Study: Using a theoretical framework to identify and address barriers to the uptake of evidence-based guidelines for acute low-back pain: a qualitative study in chiropractic and physiotherapy practice. Platform presentation at the Chiropractic and Osteopathic College of Australasia National Conference, 24-26 October 2008, Melbourne, Australia.

French S, O’Connor D, McKenzie J, and the IMPLEMENT and ALIGN Study Groups. Some examples of implementation cluster trials: experiences, methodological challenges and theory-based intervention development. Platform presentation at the Knowledge translation workshop, 14 March 2008, Melbourne, Australia.

O’Connor D, and the IMPLEMENT and ALIGN Study Groups. Using psychological theory in developing complex interventions to increase the uptake of evidence-based guidelines in clinical practice (IMPLEMENT and ALIGN). Oral presentation at the Complex interventions in public health: design, implementation, evaluation short course, 28-30 April 2008, Melbourne, Australia.
Public notes

Contacts
Principal investigator
Name 30534 0
Prof Sally Green
Address 30534 0
School of Public Health and Preventive Medicine, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne VIC 3004, Australia
Country 30534 0
Australia
Phone 30534 0
+61 3 9903 0366
Fax 30534 0
Email 30534 0
sally.green@monash.edu
Contact person for public queries
Name 13781 0
Dr Denise O’Connor or Mr Matthew Page
Address 13781 0
School of Public Health and Preventive Medicine, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne VIC 3004, Australia
Country 13781 0
Australia
Phone 13781 0
+61 3 9903 0366
Fax 13781 0
+61 3 9903 0556
Email 13781 0
denise.oconnor@monash.edu
Contact person for scientific queries
Name 4709 0
Professor Sally Green or Dr Denise O’Connor
Address 4709 0
School of Public Health and Preventive Medicine, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne VIC 3004, Australia
Country 4709 0
Australia
Phone 4709 0
+61 3 9903 0366
Fax 4709 0
+61 3 9903 0556
Email 4709 0
sally.green@monash.edu

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Results publications and other study-related documents

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SourceTitleYear of PublicationDOI
EmbaseImproving adherence to acute low back pain guideline recommendations with chiropractors and physiotherapists: the ALIGN cluster randomised controlled trial.2022https://dx.doi.org/10.1186/s13063-022-06053-x
N.B. These documents automatically identified may not have been verified by the study sponsor.