Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000731897
Ethics application status
Approved
Date submitted
7/05/2021
Date registered
10/06/2021
Date last updated
6/07/2022
Date data sharing statement initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of pre-exercise education on knee osteoarthritis (OA) pain.
Scientific title
Can a targeted pre-exercise education intervention enhance exercise induced hypoalgesia (EIH) in individuals with knee osteoarthritis (OA)?
Secondary ID [1] 304157 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 321853 0
Condition category
Condition code
Musculoskeletal 319580 319580 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 319891 319891 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of two education sessions (one-on-one interactive style lectures), 24-72 hours apart (‘Session 1’ and ‘Session 2’) delivered by a postgraduate qualified physiotherapist. Each of the two education sessions will last approximately 30 minutes and will be closely matched in duration for the intervention and control groups. The same experimenter will provide the education (intervention or control) to all participants. Participant adherence will be monitored during both sessions using a session attendance checklist.

In the intervention group, the first education session shall include information specifically tailored to counter common misconceptions and beliefs regarding osteoarthritis pain and its management. During the second 30 minute session, the intervention group’s content shall include: education about exercise induced hypoalgesia (Jones et., 2017). Upon completion of the second education session participants will complete a bout of isometric exercise where they will be instructed to maintain a target force until failure, defined as unable to sustain 25% of their maximum voluntary contraction for greater than or equal to 5-s, or a maximum of 5 minutes.
Intervention code [1] 320492 0
Rehabilitation
Comparator / control treatment
The intervention will consist of two education sessions (one-on-one interactive style lectures), 24-72 hours apart (‘Session 1’ and ‘Session 2’) delivered by a postgraduate qualified physiotherapist. Each of the two education sessions will last approximately 30 minutes and will be closely matched in duration for the intervention and control groups. Participant adherence will be monitored during both sessions using a session attendance checklist.

In the comparison group the first education session content shall include traditional OA education content sourced from a reputable international website. During the second education session, the comparison group’s content shall include: education about pain ratings and types of pain that may be associated with exercise (Jones et., 2017). Upon completion of the second education session participants will complete a bout of isometric exercise where they will be instructed to maintain a target force until failure, defined as unable to sustain 25% of their maximum voluntary contraction for greater than or equal to 5-s, or a maximum of 5 minutes
Control group
Active

Outcomes
Primary outcome [1] 327439 0
The primary outcome will be the change in exercise induced hypoalgesia magnitude from pre to post isometric exercise. Exercise induced hypoalgesia response magnitude will be calculated as the change in pressure pain threshold (PPT). Exercise induced hypalgesia response magnitude will be calculated as the change in pressure pain threshold (PPT) from immediately before to immediately after an acute bout of exercise ( isometric muscle contraction). PPT will be assessed using a hand held pressure algometer (SbMedic, Sweden) with a 1 cm rounded tip and a ramping rate of 30 kpa/s. Participants will be instructed to press a button at the moment they first experience pain from the probe (PPT) and the pressure achieved will be recorded. The average of 3 PPT measurements will be recorded for each site.
Timepoint [1] 327439 0
Exercise induced hypoalgesia response magnitude will be calculated as the change in pressure pain threshold (PPT) from immediately before to immediately after an acute bout of isometric exercise. This bout of isometric exercise will take place immediately after the second education session for both groups.
Secondary outcome [1] 395132 0
A secondary outcome measures will be the change in resting knee pain intensity before and after isometric exercise. Resting knee pain intensity will be captured in sitting, with the knee flexed at 90 degrees. A 0 to 100 numerical rating scale will be used, with anchors of 0 = no pain and 100 = worst pain imaginable.
Timepoint [1] 395132 0
The secondary outcome measure of change in resting knee pain intensity will be captured before and after a bout of isometric exercise. This bout of isometric exercise will take place immediately after the second education session for both groups.
Secondary outcome [2] 395133 0
An additional secondary outcome measure is the change in evoked pain intensity via the Staircase-Evoked Pain Procedure (StEPP) before and after isometric exercise.
Timepoint [2] 395133 0
The secondary outcome measure of change in evoked pain intensity will be captured before and after a bout of isometric exercise. This bout of isometric exercise will take place immediately after the second education session for both groups.

Eligibility
Key inclusion criteria
Participants will be included if they are males and females greater than or equal to 45 years of age, meet The National Institute for Health and Care Excellence clinical criteria for the diagnosis of knee OA, have ongoing knee pain for greater than or equal to 3 months, and have an average pain intensity of greater than or equal to 3/10 numerical rating scale (NRS) in the last week at the time of screening. In the instance where participants have bilateral knee OA, the most painful knee will become the index knee.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have an inability to speak or write English; conditions preventing safe participation in physical activity (Failed Physical Activity Readiness Questionnaire (PAR-Q), are physically unable to climb 2 flights of stairs, have ever had a total knee replacement, had recent knee surgery (past 6 months), a history of lower limb resistance training (greater than or equal to 2 times per week for a minimum of 6 weeks within the past 6 months); any other form of arthritis (e.g. rheumatoid arthritis); a history of musculoskeletal pain or injury in the lower limb (other than osteoarthritis) in the past 6 months; any neurological condition; any unstable/uncontrolled cardiovascular condition; a current diagnosis of a major psychiatric disorder; any cognitive impairment.

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)
Sealed, opaque envelopes will be used to maintain allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to the intervention or control group in a 1:1 ratio using a computer generated randomisation schedule with permuted blocks of variable size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 42 participants are required (21 in each group) to achieve a probability of 80 % that the study will detect a difference in EIH between interventions at a one-sided 0.05 significance level, with an effect size of d = 0.8. A previous study investigating a similar pre-exercise education intervention on the EIH response in a pain free population demonstrated a large effect size of d = 1.12 (Jones et., 2017). To account for increased variability in the EIH response in people with OA, a more conservative effect size of d = 0.8 has been chosen.
Descriptive statistics will be calculated using IBM SPSS version 25 (IBM Corp, Armonk, NY). Normality of the data will be assessed through visual inspection and using the Shapiro-Wilk statistic. Depending on the distribution of the data and its responsiveness to transformation procedures, a longitudinal analysis of covariance (ANCOVA) or an analysis of variance (ANOVA) will be used to examine between group differences in: EIH response (relative and absolute), change in evoked pain intensity, change in resting pain intensity and manipulation checks (KOAKS and pain and exercise belief item scores) whilst accounting for each pre-specified baseline covariates of age, anxiety and expected change in pain with exercise. Associations between the participants’ beliefs about exercise and pain and EIH will be examined using Pearson or Spearman ranked correlation coefficients. A significance level of 0.05 will be adopted. Secondary outcomes will be corrected for multiple comparisons. In the case of protocol deviations and/or missing data, the intention to treat dataset will be used for a primary analysis supported by one or more best-worst case sensitivity analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 23680 0
New Zealand
State/province [1] 23680 0
Auckland

Funding & Sponsors
Funding source category [1] 308529 0
University
Name [1] 308529 0
Auckland University of Technology, North Shore Campus
Country [1] 308529 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology, North Shore Campus
Address
90 Akoranga Drive, Northcote, Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 309386 0
None
Name [1] 309386 0
n/a
Address [1] 309386 0
n/a
Country [1] 309386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308484 0
Health and Disability Ethics Committee
Ethics committee address [1] 308484 0
Ethics committee country [1] 308484 0
New Zealand
Date submitted for ethics approval [1] 308484 0
07/05/2021
Approval date [1] 308484 0
14/06/2021
Ethics approval number [1] 308484 0
21/STH/129

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

Contacts
Principal investigator
Name 110858 0
Dr David Rice
Address 110858 0
School of Clinical Sciences
Auckland University of Technology
Auckland
1142
New Zealand
Country 110858 0
New Zealand
Phone 110858 0
+64992199997032
Fax 110858 0
n/a
Email 110858 0
[email protected]
Contact person for public queries
Name 110859 0
David Rice
Address 110859 0
School of Clinical Sciences
Auckland University of Technology
Auckland
1142
New Zealand
Country 110859 0
New Zealand
Phone 110859 0
+64992199997032
Fax 110859 0
n/a
Email 110859 0
[email protected]
Contact person for scientific queries
Name 110860 0
David Rice
Address 110860 0
School of Clinical Sciences
Auckland University of Technology
Auckland
1142
New Zealand
Country 110860 0
New Zealand
Phone 110860 0
+64992199997032
Fax 110860 0
n/a
Email 110860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent has not been given.


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.