Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001180808
Ethics application status
Approved
Date submitted
6/11/2012
Date registered
6/11/2012
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing chronic low back pain
Scientific title
A randomised controlled trial to determine whether a novel psychoeducative intervention can prevent patients with recent onset low back pain from developing chronic low back pain
Secondary ID [1] 281502 0
nil
Universal Trial Number (UTN)
U1111-1136-7401
Trial acronym
PREVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 287772 0
Condition category
Condition code
Musculoskeletal 288120 288120 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A novel psychotherapeutic intervention to be delivered by a specially trained clinician in 2 x 60 minute sessions. The 2 x 60 minute sessions will be delivered no more than 7 days apart.
Intervention code [1] 286015 0
Treatment: Other
Intervention code [2] 286016 0
Prevention
Comparator / control treatment
A sham psychotherapeutic intervention to be delivered by a specially trained clinician in 2 x 90 minute sessions. The 2 x 90 minute sessions will be delivered no more than 7 days apart
Control group
Placebo

Outcomes
Primary outcome [1] 288324 0
The primary outcome will be self-reported pain intensity (0–10 NRS average pain in the past week) at 3 months following the reported onset of symptoms.
Timepoint [1] 288324 0
3 months
Secondary outcome [1] 299856 0
a condition-specific measure of disability (Roland Morris Disability Questionnaire (RMDQ), 0-24 scale)
Timepoint [1] 299856 0
baseline; 1 week after intervention; 3, 6 and 12 months
Secondary outcome [2] 299861 0
Orebro Musculoskeletal Pain Screening Questionnaire (to determine if meaning & mood have changed).
Timepoint [2] 299861 0
baseline and 1 week after intervention.
Secondary outcome [3] 299862 0
Recurrence of low back pain
Timepoint [3] 299862 0
6 and 12 months
Secondary outcome [4] 318538 0
Chronic low back pain (equal or greater than 2/10 pain intensity (yes/no); no periods of recovery (yes/no))
Timepoint [4] 318538 0
12 month after pain onset
Secondary outcome [5] 318539 0
Disability NRS: 0–10 current and average disability in the past week
Timepoint [5] 318539 0
baseline; 1 week after intervention; 3, 6 and 12 months
Secondary outcome [6] 318540 0
Depression (Depression, Anxiety and Stress Scale)
Timepoint [6] 318540 0
baseline; one week after the intervention; 3 months
Secondary outcome [7] 318541 0
Pain Intensity NRS: 0-10 current and average pain intensity in the past week
Timepoint [7] 318541 0
baseline; 1 week after intervention; 6 and 12 months
Secondary outcome [8] 318542 0
Catastrophising (Pain Catastrophising Scale; PCS)
Timepoint [8] 318542 0
baseline and one week after intervention
Secondary outcome [9] 318543 0
Credibility (Credibility and Expectancy Questionnaire)
Timepoint [9] 318543 0
one week after intervention
Secondary outcome [10] 318544 0
Healthcare utilisation (Medication, Visits for LBP, Treatment type)
Assessed via self-report questionnaire specifically designed for this study
Timepoint [10] 318544 0
3, 6 and 12 months
Secondary outcome [11] 318545 0
Global change (Global Back Recovery Scale)
Timepoint [11] 318545 0
3 months
Secondary outcome [12] 318546 0
Pain-free and disability-free periods (Periods >1 week no pain or disability)
Assessed via self-report questionnaire specifically designed for this study
Timepoint [12] 318546 0
3 months
Secondary outcome [13] 318547 0
Neuroscience knowledge (Neurophysiology of Pain Questionnaire)
Timepoint [13] 318547 0
baseline and one week after intervention
Secondary outcome [14] 318548 0
Attitudes and beliefs (Survey of Pain Attitudes Two-item Version)
Timepoint [14] 318548 0
baseline; 1 week after intervention; 3, 6 and 12 months
Secondary outcome [15] 318549 0
Beliefs (Back Beliefs Questionnaire)
Timepoint [15] 318549 0
Baseline and one week after intervention
Secondary outcome [16] 318550 0
Self efficacy Pain (Self-Efficacy Questionnaire)
Timepoint [16] 318550 0
Baseline and one week after intervention
Secondary outcome [17] 318551 0
Reassurance (NRS 0-10 "Nothing seriously wrong")
Timepoint [17] 318551 0
baseline and one week after intervention
Secondary outcome [18] 318552 0
Reassurance ("Further investigations required"; yes/no)
Timepoint [18] 318552 0
Baseline and one week after intervention

Eligibility
Key inclusion criteria
1. The primary complaint of pain is in the area between the 12th rib and buttock crease. This may, or may not, be accompanied by leg pain.
2. A new episode of low back pain, preceded by at least one month without low back pain.
3. The duration of current symptoms is less than 6 weeks.
4. Average pain intensity equal or more than 3/10 on numeric rating scale (NRS) during the past week.
5. The duration of current symptoms is less than 6 weeks.
6. At-risk of developing chronic LBP (at-risk status will be determined using responses to seven questions: self-rated general health, presence of leg pain, previous episodes, compensation status, current pain intensity, depressive feelings and self-perceived risk of persistence).
7. Sufficient fluency in English language to understand and respond to English language questionnaires and to engage with the psychoeducative and sham interventions.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known or suspected serious spinal pathology, nerve root compromise, previous spinal surgery.
2. Uncontrolled mental health condition (eg, schizophrenia, bipolar disorder, major depressive disorder) that precludes successful participation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A primary care practitioner will identify potentially suitable participants during the the consolation for low back pain. After providing information on the study, and if the participant agrees, he/she will contact the study researcher by telephone or email with the patient contact details. The researcher will contact the participant by telephone within 24 hours to screen for inclusion in the study and to arrange an appointment at a mutually convenient time when the patient will read the Patient Information Sheet and sign the consent form. At this appointment, once the study researcher has obtained baseline data, the patient will be randomized. All participants will be reminded to continue with the care provided by their primary care clinician for their low back pain. The randomisation schedule will be used to create 202 consecutively numbered, sealed, opaque envelopes containing allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher not involved in patient recruitment or data collection will create a randomisation schedule using randomisation software.
Masking / blinding
Blinded (masking 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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
12/08/2013
Date of last participant enrolment
Anticipated
15/12/2015
Actual
11/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
202
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286283 0
Government body
Name [1] 286283 0
National Health and Medcial Research Council (NHMRC)
Country [1] 286283 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 285076 0
None
Name [1] 285076 0
Address [1] 285076 0
Country [1] 285076 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288353 0
Ethics committee address [1] 288353 0
Ethics committee country [1] 288353 0
Date submitted for ethics approval [1] 288353 0
08/11/2012
Approval date [1] 288353 0
05/02/2013
Ethics approval number [1] 288353 0

Summary
Brief summary
Eighty percent of adults will suffer back pain at some time during their life. More than one in three will develop chronic back pain and cost Australia about $9 billion per year. We can now identify those who will develop chronic back pain early. This project will test a new method of treating these people who are risk of chronic back pain. We predict that our short and targeted intervention will stop these people from developing of chronic back pain and this will lead to massive savings to the Australian community
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34923 0
Dr Dr James McAuley
Address 34923 0
Neuroscience Research Australia (NeuRA) PO Box 1165 Randwick Sydney NSW 2031
Country 34923 0
Australia
Phone 34923 0
+61 2 9399 1266
Fax 34923 0
Email 34923 0
j.mcauley@neura.edu.au
Contact person for public queries
Name 18170 0
Dr Dr. James McAuley
Address 18170 0
Neuroscience Research Australia (NeuRA)
PO Box 1165 Randwick Sydney NSW 2031
Country 18170 0
Australia
Phone 18170 0
+61 2 9399 1266
Fax 18170 0
Email 18170 0
j.mcauley@neura.edu.au
Contact person for scientific queries
Name 9098 0
Dr Dr. James McAuley
Address 9098 0
Neuroscience Research Australia (NeuRA)
PO Box 1165 Randwick Sydney NSW 2031
Country 9098 0
Australia
Phone 9098 0
+61 2 9399 1266
Fax 9098 0
Email 9098 0
j.mcauley@neura.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUnderstanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.2015https://dx.doi.org/10.1016/j.jphys.2015.03.004
EmbaseProducing Clinically Meaningful Reductions in Disability: A Causal Mediation Analysis of a Patient Education Intervention.2022https://dx.doi.org/10.1016/j.jpain.2021.07.007
EmbaseEffect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients with Acute Low Back Pain: A Randomized Clinical Trial.2019https://dx.doi.org/10.1001/jamaneurol.2018.3376
N.B. These documents automatically identified may not have been verified by the study sponsor.