Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000966291
Ethics application status
Approved
Date submitted
9/11/2009
Date registered
9/11/2009
Date last updated
10/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Paracetamol for low back pain
Scientific title
In patients with acute low back pain is time contingent paracetamol, or pro re nata (PRN) paracetamol, more effective than placebo in speeding recovery from a new episode of low back pain?
Secondary ID [1] 282291 0
Nil known
Universal Trial Number (UTN)
U1111-1112-2983
Trial acronym
PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute low back pain 252064 0
Condition category
Condition code
Musculoskeletal 252265 252265 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Time-contingent paracetamol: 2 tablets extended release paracetamol (665mg) 3 times daily, every 6-8 hours, spaced equally throughout the day (maximum 6 per day) until recovery or maximum 4 weeks; and PRN placebo (identical to the PRN paracetamol except for the active ingredient).

PRN Paracetamol: 1-2 500mg paracetamol tablets every 4-6 hours as required for pain relief (maximum 8 per day) until recovery or maximum 4 weeks; and time-contingent placebo (identical to the time-contingent paracetamol except for the active ingredient).
Intervention code [1] 241458 0
Treatment: Drugs
Comparator / control treatment
Double placebo:
Time-contingent placebo paracetamol - 2 tablets 3 times daily every 6-8 hours spaced equally throughout the day (maximum 6 per day) until recovery or maximum 4 weeks; and
PRN placebo paracetamol - 1-2 tablets every 4-6 hours as required for pain relief (maximum 8 per day) until recovery or maximum 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 253136 0
Days to recovery with recovery defined as a pain score of 0 or 1 on a 0-10 pain scale (numerical pain rating scale) that is maintained for seven consecutive days.
Timepoint [1] 253136 0
Measured daily from baseline until recovered.
Primary outcome [2] 253187 0
Days to recovery with recovery defined as the first day that the participant has a pain score of 0 or 1 on a 0 to 10 numerical pain rating scale.
Timepoint [2] 253187 0
Measured daily from baseline until recovered.
Secondary outcome [1] 262017 0
Pain score - numerical pain rating scale
Timepoint [1] 262017 0
Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks
Secondary outcome [2] 262024 0
Disability - Roland Morris Disability Questionnaire
Timepoint [2] 262024 0
Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks
Secondary outcome [3] 262025 0
Function - Patient Specific Functional Scale
Timepoint [3] 262025 0
Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks
Secondary outcome [4] 262026 0
Global Perceived Effect Scale
Timepoint [4] 262026 0
Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks
Secondary outcome [5] 262027 0
Subjective Sleep Quality - Item 6 Pittsburgh Sleep Quality Index
Timepoint [5] 262027 0
Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks
Secondary outcome [6] 262028 0
Quality of Life - Short Form 12
Timepoint [6] 262028 0
Baseline, 4 weeks, 12 weeks

Eligibility
Key inclusion criteria
Primary complaint of pain in the area between the 12th rib and buttock crease, with/without leg pain;
New episode of low back pain, preceded by a period of at least one month without low back pain;
Pain of less than 6 weeks duration;
Low back pain severe enough to cause at least ‘moderate pain’ (as measured by an adaptation of item 7 of the Short Form-36).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious spinal pathology;
Currently taking recommended regular doses of paracetamol;
Currenlty taking recommended regular doses of another analgesic for a pre-existing condition;
Spinal surgery within the preceding 6 months;
Currently taking psychotropic medication and whose health condition is considered to prevent reliable recording of study information;
Serious co-morbidities preventing prescription of paracetamol;
Pregnancy or planning a pregnancy during the one-month treatment period.

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)
Participants will be enrolled by general practitioners across greater metropolitan Sydney. After determining eligibility the general practitioner will allocate the participant by handing over a sealed randomised medication pack.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated a priori by an independent investigator using the random number function in EXCEL.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Double-dummy placebo design
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/11/2009
Actual
11/11/2009
Date of last participant enrolment
Anticipated
Actual
13/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
1650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243931 0
Government body
Name [1] 243931 0
National Health and Medical Research Council
Country [1] 243931 0
Australia
Funding source category [2] 243966 0
Commercial sector/Industry
Name [2] 243966 0
GlaxoSmithKline
Country [2] 243966 0
Australia
Funding source category [3] 243981 0
Government body
Name [3] 243981 0
Australian Research Council
Country [3] 243981 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for International Health
Address
Level 7, 341 George St
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 251346 0
None
Name [1] 251346 0
Address [1] 251346 0
Country [1] 251346 0
Other collaborator category [1] 935 0
Individual
Name [1] 935 0
Associate Professor Jane Latimer
Address [1] 935 0
The George Institute for International Health and Sydney Medical School
The University of Sydney,
NSW 2006
Country [1] 935 0
Australia
Other collaborator category [2] 936 0
Individual
Name [2] 936 0
Professor Chris Maher
Address [2] 936 0
The George Institute for International Health and Sydney Medical School
The University of Sydney,
NSW 2006
Country [2] 936 0
Australia
Other collaborator category [3] 945 0
Individual
Name [3] 945 0
Professor Andrew McLachlan
Address [3] 945 0
Faculty of Pharmacy and Centre for Education and Research in Ageing,
Pharmacy Building (A15)
University of Sydney,
Sydney NSW 2006
Country [3] 945 0
Australia
Other collaborator category [4] 946 0
Individual
Name [4] 946 0
Dr Mark Hancock
Address [4] 946 0
Discipline of Physiotherapy
Faculty of Health Sciences,
University of Sydney,
PO Box 170
Lidcombe NSW 1825
Country [4] 946 0
Australia
Other collaborator category [5] 947 0
Individual
Name [5] 947 0
Professor Richard Day
Address [5] 947 0
Clinical Pharmacology & Toxicology, Therapeutics Centre,
St Vincent's Hospital,
Darlinghurst NSW 2010
Country [5] 947 0
Australia
Other collaborator category [6] 948 0
Individual
Name [6] 948 0
Dr Chris Cooper
Address [6] 948 0
Discipline of General Practice,
The University of Sydney
37A Booth St (C75),
Balmain, NSW 2041
Country [6] 948 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244041 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 244041 0
Level 6
Jane Foss Russell Building G02
The University of Sydney
NSW 2006 AUSTRALIA
Ethics committee country [1] 244041 0
Date submitted for ethics approval [1] 244041 0
Approval date [1] 244041 0
14/05/2009
Ethics approval number [1] 244041 0
05-2009/11638

Summary
Brief summary
A randomised controlled trial will be conducted of 1650 patients seeking care for recent onset low back pain. The trial will assess the effect that paracetamol has on the recovery from low back pain. Specifically, it will determine whether paracetamol shortens days to recovery from low back pain compared to placebo, and whether taking a ‘regular dosing’ of paracetamol is more effective than taking an ‘as required’ dosing. The trial will also measure the effect of paracetamol on disability, function, sleep quality and determine the cost-effectiveness of paracetamol for managing patients with low back pain.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 30421 0
A/Prof Jane Latimer
Address 30421 0
The George Institute for Global Health
Level 13, 321 Kent St Sydney NSW 2000 Australia
Country 30421 0
Australia
Phone 30421 0
+61 2 9657 0384
Fax 30421 0
Email 30421 0
[email protected]
Contact person for public queries
Name 13668 0
Dr Chris Williams
Address 13668 0
The George Institute for Global Health
Level 13, 321 Kent St Sydney NSW 2000 Australia
Country 13668 0
Australia
Phone 13668 0
+61 2 82382412
Fax 13668 0
+61 2 85806242
Email 13668 0
[email protected]
Contact person for scientific queries
Name 4596 0
A/Prof Jane Latimer
Address 4596 0
The George Institute for Global Health
Level 13, 321 Kent St Sydney NSW 2000 Australia
Country 4596 0
Australia
Phone 4596 0
+61 2 96570384
Fax 4596 0
Email 4596 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial.2014https://dx.doi.org/10.1016/S0140-6736%2814%2960805-9
EmbasePharmacists' views on implementing a disease state management program for low back pain.2016https://dx.doi.org/10.1071/PY14116
EmbaseEfficacy and Safety of Oral and Transdermal Opioid Analgesics for Musculoskeletal Pain in Older Adults: A Systematic Review of Randomized, Placebo-Controlled Trials.2018https://dx.doi.org/10.1016/j.jpain.2017.12.001
Dimensions AIPACE – the first placebo controlled trial of paracetamol for acute low back pain: statistical analysis plan2013https://doi.org/10.1186/1745-6215-14-248
N.B. These documents automatically identified may not have been verified by the study sponsor.