Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001095853
Ethics application status
Approved
Date submitted
7/07/2021
Date registered
18/08/2021
Date last updated
4/08/2023
Date data sharing statement initially provided
18/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The preparation for knee surgery study: Psychological therapy to prepare for knee joint replacement
Scientific title
Psychological therapy to prepare for knee joint replacement: A feasibility trial
Secondary ID [1] 304720 0
nil
Universal Trial Number (UTN)
U1111-1243-1067
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 322740 0
Condition category
Condition code
Surgery 320331 320331 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychological Intervention prior to surgery. Participants will be recruited to begin the intervention approx 3 months prior to surgery.

The cognitive-behavioural therapy and pain neuroscience-education based psychological intervention aims to alter pain expectations and anxiety. The intervention includes 3 individual fortnightly phone/video call appointments (2x1hr, 1x20min) accompanied by a information book, workbook, and website including a social modelling video and recordings of relaxation techniques (all created specifically for the study). Participants do the intervention in their own homes. The intervention is provided by one of two health psychologists with 4 & 15 years' clinical experience each.

The appointments include discussion of:
Appt 1: Pain neuroscience and how this might influence post-operative pain, strategies to manage pain, goal setting for meaningful activities after surgery.
Appt 2: Follow-up on goal setting, the influence of stress and anxiety on pain, physiology of stress, using relaxation techniques, instructions for practice.
Appt 3: Recap previous content, review use of relaxation techniques, plans for using pain management strategies at time of surgery.

Adherence will be monitored using session attendance checklists, recording of homework activities (watched video, set 3 goals, practiced relaxation techniques) and participants are asked to rate the extent to which they read the workbook and website.

The intervention was designed to later be combined with multi-modal interventions (e.g. exercise, medication management) to prevent the development of chronic pain after surgery, but is being tested for acceptability and feasibility as a single-modal intervention in this study.
Intervention code [1] 321100 0
Behaviour
Intervention code [2] 321101 0
Prevention
Comparator / control treatment
The study is not recruiting a control group but post-surgical outcome data will be compared with an historic dataset of TKA patients from an observational study: Rice et al. (2018) Persistent postoperative pain after total knee arthroplasty: a prospective cohort study of potential risk factors, Br J Anaesth. 121(4):804-812. doi: 10.1016/j.bja.2018.05.070.
Control group
Historical

Outcomes
Primary outcome [1] 328185 0
Expected pain: measured with single item (from Rice et al., 2018): “Please indicate the level of pain you think you will experience in your operated knee six months after your surgery”. The response format will be an 11-point likert scale with anchors 0 (no pain) to 10 (extreme pain).
Timepoint [1] 328185 0
Baseline and end of intervention (i.e. 4 weeks from commencement of intervention).
Primary outcome [2] 328186 0
Anxiety: State Trait Anxiety Inventory mean score
Timepoint [2] 328186 0
Baseline and end of intervention (i.e. 4 weeks from commencement of intervention) and 6 months post-surgery
Primary outcome [3] 328187 0
Intervention Acceptability & Feasibility: Intervention ratings as assessed by study-specific questionnaire, answers to study-specific open-ended questions, recruitment and completion rates as assessed by audit of study records
Timepoint [3] 328187 0
Intervention ratings and answers to open-ended questions will be assessed 4 weeks post-commencement of intervention; recruitment and completion rates will be assessed at the conclusion of the study.
Secondary outcome [1] 397955 0
Pain Intensity: WOMAC mean pain intensity
Timepoint [1] 397955 0
Baseline and end of intervention (i.e. 4 weeks from commencement of intervention) and 6 months post-surgery
Secondary outcome [2] 397956 0
Pain Intensity: 11 point numeric rating scale
Timepoint [2] 397956 0
Baseline and end of intervention (i.e. 4 weeks from commencement of intervention) and 6 months post-surgery
Secondary outcome [3] 397957 0
Disability: WOMAC mean disability score
Timepoint [3] 397957 0
Baseline and end of intervention (i.e. 4 weeks from commencement of intervention) and 6 months post-surgery
Secondary outcome [4] 397958 0
Pain catastrophising: Pain Catastrophising Scale mean scores
Timepoint [4] 397958 0
Baseline and end of intervention (i.e. 4 weeks from commencement of intervention) and 6 months post-surgery
Secondary outcome [5] 397959 0
Pain Self-Efficacy: Pain Self-Efficacy Questionnaire mean scores
Timepoint [5] 397959 0
Baseline and end of intervention (i.e. 4 weeks from commencement of intervention) and 6 months post-surgery
Secondary outcome [6] 397960 0
Expectations for Surgery: Expectation for Treatment Scale (ETS) (Barth, Kern, Lüthi, & Witt, 2019)
Timepoint [6] 397960 0
Baseline and end of intervention (i.e. 4 weeks from commencement of intervention).

Eligibility
Key inclusion criteria
1. Planned first primary unilateral TKA
2. Fluent in English
3. 18yrs or older
4. Elevated anxiety and expected pain post-surgery:
a. 6-item short-form trait anxiety scale from State-Trait Anxiety Inventory score >/= 11 (sum of items 22, 26, 27, 29, 34, 36, 40), and
b. Expected Pain: Measured by a single question: ‘Please indicate the level of pain you think you will experience in your operated knee six months after your surgery (0-10)’; scores >/= 1/10.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent
Illiteracy
Diagnosis of cognitive impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Comparison with historical cohort, see above.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
30 participants will be recruited into this feasibility trial.
Data will be entered in SPSS Statistics v25. Data will be screened for normality and outliers.
Descriptive statistics will be used to describe recruitment and completion rates, percentage of missing data, and acceptability scores.
Change in questionnaire scores from pre- to post- intervention will be used to determine effect sizes for change in anxiety and change in expeced pain.
WOMAC pain and function scores at 6 months post-surgery will be compared to the same data from a historic cohort . This will be used to aide a power calculation for a future RCT.
Patient comments will be summarised.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/04/2021
Date of last participant enrolment
Anticipated
4/10/2021
Actual
25/02/2022
Date of last data collection
Anticipated
31/07/2023
Actual
19/07/2023
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 23949 0
New Zealand
State/province [1] 23949 0
Auckland

Funding & Sponsors
Funding source category [1] 309096 0
University
Name [1] 309096 0
Auckland University of Technology
Country [1] 309096 0
New Zealand
Primary sponsor type
Hospital
Name
North Shore Hospital
Address
Shakespeare Rd, Takapuna, Auckland 0620
Country
New Zealand
Secondary sponsor category [1] 310042 0
None
Name [1] 310042 0
Address [1] 310042 0
Country [1] 310042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308963 0
Health & Disability Ethics Committee
Ethics committee address [1] 308963 0
Ethics committee country [1] 308963 0
New Zealand
Date submitted for ethics approval [1] 308963 0
20/11/2019
Approval date [1] 308963 0
27/11/2019
Ethics approval number [1] 308963 0
19/NTB/208/AM01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112494 0
Dr Debbie Bean
Address 112494 0
Pain Management Service
Level 10 North Shore Hospital
Shakespeare Rd
Takapuna
Auckland 0620
Country 112494 0
New Zealand
Phone 112494 0
+64 9 4868900 48944
Fax 112494 0
Email 112494 0
[email protected]
Contact person for public queries
Name 112495 0
Debbie Bean
Address 112495 0
Pain Management Service
Level 10 North Shore Hospital
Shakespeare Rd
Takapuna
Auckland 0620
Country 112495 0
New Zealand
Phone 112495 0
+64 9 4868900
Fax 112495 0
Email 112495 0
[email protected]
Contact person for scientific queries
Name 112496 0
Debbie Bean
Address 112496 0
Pain Management Service
Level 10 North Shore Hospital
Shakespeare Rd
Takapuna
Auckland 0620
Country 112496 0
New Zealand
Phone 112496 0
+64 9 4868900
Fax 112496 0
Email 112496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification; individual participant data underlying published results
When will data be available (start and end dates)?
Up to 10 years after study completion (2022-2032)
Available to whom?
Only researchers who provide a methodologically sound proposal, assessed on a case-by-case basis at the discretion of the research team
Available for what types of analyses?
Meta-analysis or other methodologically sound analyses, assessed on a case-by-case basis at the discretion of the research team
How or where can data be obtained?
On request from [email protected]


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
No additional documents have been identified.