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Trial registered on ANZCTR


Registration number
ACTRN12612001089820
Ethics application status
Approved
Date submitted
2/10/2012
Date registered
11/10/2012
Date last updated
11/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictors of pain after knee joint replacement
Scientific title
Predictors of persistent pain after total knee arthroplasty in patients with chronic arthritis
Secondary ID [1] 281332 0
Nil known
Universal Trial Number (UTN)
U1111-1135-3502
Trial acronym
CPAKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee replacement 287551 0
arthritis 287552 0
knee injury 287553 0
Condition category
Condition code
Musculoskeletal 287875 287875 0 0
Osteoarthritis
Anaesthesiology 287876 287876 0 0
Pain management
Musculoskeletal 287877 287877 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A number of clinical, psychological, neurophysiological and genetic variables will be collected preoperatively and perioperatively to ascertain which are significant, independent predictors of persistent knee pain 6 months after undergoing primary total knee joint arthroplasty. The predictor variables collected will be as follows:


Preoperative Predictors (Assessed 1-3 weeks before surgery)
1. Preoperative Knee Pain - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale
2. Comorbid Pain - Pain > 2/10 on numerical rating scale (0 = no pain; 10 = extreme pain) that has been present on at least a weekly basis for 1 month or longer. Count number of anatomical locations apart from index knee where this is true (e.g. n = 3).
3. Pain expectation - measured using the following question "Please indicate the level of pain you think you will experience in your operated knee 6 months after your surgery?" 0-10 Numerical rating scale (0= no pain; 10 = extreme pain).
4. Pain Catastrophising - measured using the Pain Catastrophsing Scale
5. Depression - measured using the Beck depression inventory
6. Anxiety - measured using the state trait anxiety inventory
7. Temporal summation of mechanical pain - assessed through the repetition of 10 standardised punctuate stimuli at a frequency of 1 Hz, applied to an area of the skin 1cm lateral to the midline of the patella using a 225.1g Von Frey filament. Patients will be asked to rate the pain intensity of the first and last stimuli on a 0-10 numerical rating scale (0 = no pain; 10 = extreme pain). The difference in pain intensity between the last and first stimuli will be calculated to indicate the magnitude of temporal summation.
8. Conditioned Pain Modulation Efficacy - Pressure pain threshold at the index knee will be assessed alone (test stimulus) and while the contralateral hand is sumberged in cold water (conditioning stimulus). The difference in pressure pain thresholds (kPA; mean of 3 measures) with and without the conditioning stimulus will be used as a measure of conditioned pain modulation efficacy.
9. Single nucleotide polymorphisms for the Catechol-O-methyl transferase (COMT), mu opiod receptor (OPRM-1), tumor necrosis factor alpha (tnf-alpha); interleukin-1 (IL-1) and interleukin-6 (IL-6) genes - obtained through a single blood sample that will be taken at the same time as routine preoperative bloods. Standard DNA extraction, polymerase chain reaction, microarray and detection methods will be used to identify single nucleotide polymorphisms.

Perioperative Predictors (assessed Day 1-3 post op)
1. Acute pain at rest - Pain scored on a 0-10 numerical rating scale (0 = no pain, 10 = extreme pain) while lying in a supine position with knee extended. Sum of pain scores on post op days 1-3 taken as acute pain at rest.
2. Acute pain on movement - Pain scored 0-10 numerical rating scale (0 = no pain, 10 = extreme pain) after moving knee into maximum flexion and returning to extended position. Sum of pain scores on post op days 1-3 taken as acute pain on movement.
Intervention code [1] 285794 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288095 0
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale.
Timepoint [1] 288095 0
6 months post surgery, 12 months post surgery.
Secondary outcome [1] 299423 0
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale
Timepoint [1] 299423 0
6 months post surgery
Secondary outcome [2] 299424 0
Leeds Assessment of Neuropathic Signs and Symptoms
Timepoint [2] 299424 0
6 months post surgery

Eligibility
Key inclusion criteria
Scheduled to undergo primary total knee joint arthroplasty at North Shore or Waitakere Hospital in Auckland; Fluent readers and speakers of the English language.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years of age, diagnosed learning disability, Raynaud's syndrome, Unsuitable candidate for spinal epidural procedure.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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 outside Australia
Country [1] 4580 0
New Zealand
State/province [1] 4580 0
Auckland

Funding & Sponsors
Funding source category [1] 286095 0
University
Name [1] 286095 0
Health and Rehabilitation Research Institute, AUT University
Address [1] 286095 0
90 Akoranga Drive
Northcote
Auckland
0626
Country [1] 286095 0
New Zealand
Funding source category [2] 286096 0
Charities/Societies/Foundations
Name [2] 286096 0
Australia New Zealand College of Anaesthetists
Address [2] 286096 0
630 St Kilda Road

Melbourne Vic 3004
Country [2] 286096 0
Australia
Primary sponsor type
Individual
Name
Dr Michal Kluger
Address
Dept of Anaesthesiology and Perioperative Medicine
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country
New Zealand
Secondary sponsor category [1] 284908 0
Individual
Name [1] 284908 0
David Rice
Address [1] 284908 0
Health and Rehabilitation Research Institute
90 Akoranga Drive
Northcote
Auckland
0626

and

Dept of Anaesthesiology and Perioperative Medicine
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country [1] 284908 0
New Zealand
Other collaborator category [1] 277105 0
Individual
Name [1] 277105 0
Dr Gwyn Lewis
Address [1] 277105 0
Health and Rehabilitation Research Institute
90 Akoranga Drive
Northcote
Auckland
0626
Country [1] 277105 0
New Zealand
Other collaborator category [2] 277106 0
Individual
Name [2] 277106 0
Professor Peter McNair
Address [2] 277106 0
Health and Rehabilitation Research Institute
90 Akoranga Drive
Northcote
Auckland
0626
Country [2] 277106 0
New Zealand
Other collaborator category [3] 277107 0
Individual
Name [3] 277107 0
Professor Andrew Somogyi
Address [3] 277107 0
Discipline of Pharmacology
Faculty of Health Sciences, University of Adelaide
Adelaide, 5005, South Australia
Country [3] 277107 0
Australia
Other collaborator category [4] 277108 0
Individual
Name [4] 277108 0
Dr Matthew Walker
Address [4] 277108 0
Dept of Orthopaedic Surgery
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country [4] 277108 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288146 0
Northern Regional Y Ethics Committee
Ethics committee address [1] 288146 0
c/- Ministry of Health
Level 3, Bridgewater Building
130 Grantham St
Hamilton 3204
Ethics committee country [1] 288146 0
New Zealand
Date submitted for ethics approval [1] 288146 0
15/11/2011
Approval date [1] 288146 0
19/04/2012
Ethics approval number [1] 288146 0
NTY12_02_112

Summary
Brief summary
Following joint replacement surgery the amount of pain that people experience varies a lot between individuals, despite similar surgical techniques and the same postoperative pain medications. This study will assess people just before and just after their surgery and measure a number of different factors (e.g. age, pain related beliefs and expectations, individual differences in “pain genes” and “pain thresholds”). The aim of this study is to see which of these factors can help us predict who has ongoing pain 6 months after their surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34784 0
Address 34784 0
Country 34784 0
Phone 34784 0
Fax 34784 0
Email 34784 0
Contact person for public queries
Name 18031 0
David Rice
Address 18031 0
Health and Rehabilitation Research Institute
AUT University
90 Akoranga Drive
Northcote
0626
Country 18031 0
New Zealand
Phone 18031 0
+64 921 9999
Fax 18031 0
Email 18031 0
david.rice@aut.ac.nz
Contact person for scientific queries
Name 8959 0
David Rice
Address 8959 0
Health and Rehabilitation Research Institute
AUT University
90 Akoranga Drive
Northcote
0626
Country 8959 0
New Zealand
Phone 8959 0
+64 921 9999
Fax 8959 0
Email 8959 0
david.rice@aut.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results