Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001149257
Ethics application status
Approved
Date submitted
6/07/2018
Date registered
12/07/2018
Date last updated
22/10/2021
Date data sharing statement initially provided
22/10/2021
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does targeting pain-related beliefs in people with knee osteoarthritis increase physical activity? A pilot, feasibility trial.
Scientific title
Does targeting pain-related beliefs in people with knee osteoarthritis increase physical activity? A randomised, sham-controlled, feasibility trial.
Secondary ID [1] 295448 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 308702 0
Condition category
Condition code
Musculoskeletal 307640 307640 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Explain Pain Group (enhanced education + graded walking program)

Participants randomised to this group will attend four, 60-90 minute, one-on-one sessions with a Physiotherapist at weekly intervals, during which they will receive enhanced pain education (Explain Pain) as well as receiving a graded walking program. The overall aim of Explain Pain is to shift participants’ conceptualisation of pain from that of a marker of tissue damage to that of a marker of the perceived need to protect the body. The Explain Pain enhanced education will also expand upon general information about osteoarthritis and activity (received by control group). The physiotherapist will have received specific training in Explain Pain including a 2-day course and 4 months of specific training with the research team.

Explain Pain is a cutting edge educational approach that moves away from didactic lectures/seminars. It aims to educate participants that pain is a protective feature of our system, not a ‘damage-meter’; thus, pain can be modulated by other things besides tissue damage and danger messages (i.e. nociception). It will aim to reduce the perceived danger associated with the knee, using proven principles and strategies of conceptual change science. Conceptual change strategies informed by contemporary theory will be used, including: challenging existing knowledge and refining learning strategies for new concepts using principles of multimedia learning will be used. A detailed curricula has been created for this intervention.

The following pain education topics will be covered in the one-on-one sessions: Basic nervous system anatomy/function; distinction between nociception and pain; protective function of pain; peripheral/central sensitization; up-regulation of brain mechanisms that serve protection; the state of ‘hyper-protection’ offered by normal bio-logical adaptations; the concept of an internal ‘Protectometer’ (modulated by multifaceted danger and safety cues). Further, a discussion of the participants’ own knee xray will be undertaken with the aim being to ‘de-threaten’ radiological findings (e.g., focusing on positive features such as excellent bone density) using standardised wording. Education about the poor correlation between x-ray findings and pain will be provided. Specific education about physical activity will be provided, namely that it does not increase joint damage but does have wide-ranging health benefits and OA-specific benefits. Last, it will be discussed that physical activity is key to bioplasticity – i.e., inducing changes in our system – and that it decreases overprotectiveness of our system, a change that often occurs with persistent pain. Participants will receive the Explain Pain book to take home which discusses concepts from this intervention.

In the one-on-one sessions, participants will also receive a graded walking problem. This will involve first establishing participant’s baseline walking tolerance (i.e. how far, on average, they are able to walk before their pain level increases). They will then reduce this time/distance by 20% - with this activity level becoming their ‘start’ walking level. Participants will be guided to set a weekly program (beginning at this ‘start’ level) and then plan gradual weekly increases at a rate of approximately 10% each week. Participants will also be guided to set activity-related short and long-term goals. One of these goals will be a walking goal (if appropriate) – such that the ‘pacing’ approach can be demonstrated and practiced.

Following completion of the one-on-one sessions, participants will perform 4 weeks of at-home workbook activities combined with further progression of a graded walking program. This will include
weekly individualised walking goals that aim to promote graded activity progression. Participants will also receive the Protectometer handbook, which is an interactive and educational Explain Pain workbook. Participants will be asked to complete tasks at home which will involve using the Protectometer handbook to identify the unique safety and danger cues that are present for activity tasks and that may influence pain levels during activity. During the 4 weeks of at-home treatment activities, the treating clinician will call participants 1x/week to check in and follow their progress. A home diary will be used to record workbook/walking goal completion.
Intervention code [1] 301756 0
Lifestyle
Intervention code [2] 301757 0
Treatment: Other
Comparator / control treatment
Standard education & Sham Ultrasound group (control + graded walking program)

Participants randomised to this group will attend four, 60 minute, one-on-one sessions with a Physiotherapist at weekly intervals, during which they will receive general information about osteoarthritis and activity. They will also receive a graded walking program. The general education provided will be consistent with standard care – i.e., using Arthritis Australia resources. However, in order to match time with the treating therapist between groups, this group will also receive sham treatment in the form of inactive ultrasound using inert gel (as per previous work). This will be provided to 4 locations on the painful knee (5 mins per location). While the sham treatment is being administered, the treating clinician will aim to engage the participant in general conversation. If participants discuss their knee pain and related concerns, the treating clinician will only offer advice and/or information consistent with the readily available, quality resource for knee osteoarthritis (Arthritis Australia resources).

The overall aim of this treatment group will be to act as a usual care control by providing standard education to increase participants’ knowledge about osteoarthritis and the importance of physical activity in reducing osteoarthritic pain and increasing general health (and that even people with severe osteoarthritis can benefit). Participants in this group will receive a discussion of their own personal knee xray. However, the content will differ significantly from the Explain Group. The aim will be to discuss radiological findings, focusing on the interpretation section of the report. We will specifically discuss the xray features that resulted in participants receiving a diagnosis of OA. In the one-on-one sessions, participants will receive a graded walking program identical to that received by the Explain pain group.

Following completion of the one-on-one sessions, participants will perform 4 weeks of at-home workbook activities combined with further progression of a graded walking program. This will include
weekly individualised walking goals that aim to promote graded activity progression (identical to Explain Pain Group). Participants will receive a workbook that includes information and questions about the known benefits of activity, health risk of inactivity, and the relevance to OA. They will complete sections of this workbook over the 4 weeks. During the 4 weeks of at-home treatment activities, the treating clinician will call participants 1x/week to check in and follow their progress. A home diary will be used to record workbook/walking goal completion.
Control group
Active

Outcomes
Primary outcome [1] 306625 0
The primary outcome of this study is to assess the feasibility of successfully conducting a large RCT that investigates the effect of adding Explain Pain (vs adding sham treatment) to an individualised, physiotherapist-led physical activity and general education program in adults with painful knee OA - through the evaluation of pre-specified feasibility criteria.

The specific feasibility criteria will include: 1) eligibility (number of eligible participants identified/week); 2) recruitment (% of eligible participants recruited/week); 3) treatment completion (% of participants that complete at least 3 of 4 in-person treatment sessions and % that complete at-home treatment)l 4) intervention fidelity (% of intervention sessions provided in full content); 5) follow-up (loss to follow-up at 6 months); 6) objective physical activity assessment (% of participants with at least 4 days of valid wear time using wrist-based accelerometry).

This is a composite primary outcome measure.
Timepoint [1] 306625 0
Feasibility outcomes will be evaluated at the interim stage of the feasibility trial – after recruitment of 1/3 of the study participants – as well as at trial completion (6 months).
Primary outcome [2] 306626 0
The primary pilot outcome of the trial is to assess participants’ perspectives on the clinical interventions with the aim to improve intervention content and delivery to maximise benefit in future studies.

Participant treatment content acceptability/usefulness, treatment delivery acceptability, and sham credibility will be assessed via agreement with acceptability/usefulness/ credibility statements. Participants will rate agreement for these statements using 5-point Likert scales ranging from “strongly agree” to “strongly disagree” . Acceptability will also be informed by a telephone interview at 4 and 8 weeks.
Timepoint [2] 306626 0
4 weeks (end of in-person intervention; primary timepoint), 8 weeks (end of at-home intervention), 6 months post-baseline)
Primary outcome [3] 306723 0
The primary pilot outcome of the trial is to assess treating clinicians’ perspectives on the clinical interventions with the aim to improve intervention content and delivery to maximise benefit in future studies.

Clinician treatment content acceptability/usefulness, and treatment delivery acceptability will be assessed via agreement with acceptability/usefulness/credibility statements. Clinicans will rate agreement for these statements using 5-point Likert scales ranging from “strongly agree” to “strongly disagree” . Acceptability will also be informed by an informal interview at trial completion.
Timepoint [3] 306723 0
4 weeks (after in-person sessions), 8 weeks (after at-home sessions), at trial completion (primary time point).
Secondary outcome [1] 349053 0
Physical activity level: average daily step-count measured using wrist-based acclerometry (GT9x Actigraph)
Timepoint [1] 349053 0
Baseline, 4 weeks, 8 weeks and 6 months
Secondary outcome [2] 349054 0
Knee pain intensity measured using a 0-100mm visual analogue scale where 0 = no pain at all and 100 = most pain imaginable.
Timepoint [2] 349054 0
Baseline, 4 weeks, 8 weeks and 6 months
Secondary outcome [3] 349075 0
Pain knowledge measured using the revised Neurophysiology of Pain Questionnaire
Timepoint [3] 349075 0
Baseline, 4 weeks, 8 weeks, 6 months
Secondary outcome [4] 349076 0
Osteoarthritis pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale.
Timepoint [4] 349076 0
Baseline, 4 weeks, 8 weeks, 6 months
Secondary outcome [5] 349077 0
Pain self-efficacy as measured by the Pain Self-efficacy scale
Timepoint [5] 349077 0
Baseline, 4 weeks, 8 weeks, 6 months
Secondary outcome [6] 349078 0
Pain Catastrophising as measured using the Pain Catastrophising Scale
Timepoint [6] 349078 0
Baseline, 4 weeks, 8 weeks, 6 months
Secondary outcome [7] 349079 0
Fear of movement as measured by the Brief fear of movement scale
Timepoint [7] 349079 0
Baseline, 4 weeks, 8 weeks, 6 months
Secondary outcome [8] 349080 0
Psychological function as measured by the Depression, Anxiety and Stress Scale (DASS)
Timepoint [8] 349080 0
Baseline, 4 weeks, 8 weeks, and 6 months
Secondary outcome [9] 349092 0
Pain Beliefs as measured by the Pain Beliefs Questionnaire
Timepoint [9] 349092 0
Baseline, 4 weeks, 8 weeks, and 6 months
Secondary outcome [10] 349093 0
Function as measured by the Patient-Specific Functional Scale
Timepoint [10] 349093 0
Baseline, 4 weeks, 8 weeks, and 6 months
Secondary outcome [11] 349238 0
Osteoarthritis function as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale.
Timepoint [11] 349238 0
Baseline, 4 weeks, 8 weeks, 6 months

Eligibility
Key inclusion criteria
- Adults aged 50yrs and older
- Painful knee OA of at least 6 months duration that meets the American College of Rheumatology (ACR) clinical criteria for knee OA.
- Average knee pain (overall and/or during walking) over one week rated as greater than or equal to 40mm on a 0-100mm visual analogue scale (VAS)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Conditions that prevent safe participation in physical activity (e.g., severe cardiac/lung disease); neurological disorders affecting lower limb (e.g., stroke, multiple sclerosis); inflammatory arthritis; fibromyalgia
- Cognitive impairment (e.g., Alzheimer’s, dementia); severe depression (>21 on DASS24)
- Previous knee replacement (on painful knee) or planned knee replacement or surgery (next 6 months)
- Recent intra-articular therapy (past 3 months)
- Report moderate/vigorous activity levels above guideline recommendation (>150mins/wk; assessed via International Physical Activity Questionnaire; IPAQ)
- Do not have a radiograph or other imaging report of their affected knee

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)
Allocation will be concealed in sequentially numbered, sealed, opaque envelopes created by an investigator not involved in the study data collection or interventions. Eligible patients who have provided informed consent will be allocated to the treatment groups by an independent investigator who will then coordinate treatment appointment scheduling with the appropriate therapist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated (1:1) to intervention groups using a randomisation schedule generated by Excel’s randomisation function, using random permutated blocks of 4 and 6. The randomisation schedule will be completed by an independent investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Participants and the outcome assessor will be blinded to group assignment. Participants will be advised that they will be randomised to receive one of two physiotherapy treatments that aim to improve overall health (i.e., limited disclosure). Given that both groups include active treatment and given that we will not identify the primary outcomes of the study, we anticipate that this will be sufficient for blinding. The outcome assessor will be a researcher whose role is independent to treatment allocation and delivery, thus will remain blinded to group. Participants will be explicitly instructed not to discuss their treating therapist with the outcome assessor. Follow-up assessments will occur at week 4, 8, and 26 weeks, and will be performed by the same, blinded assessor. The treating clinician will be unavoidably aware of group assignment, but will not be involved in any outcome assessment.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive measures will be used to determine feasibility. Participant recruitment rates will be recorded, including the number of eligible participants that agree to participate and the reasons why participants choose not to participate. The proportion of participants completing the in-person and at-home treatment will be evaluated, as will the proportion of participants with valid accelerometry wear-time. We will also assess loss to follow-up (% with valid data). Using the audio recorded treatments, we will assess the proportion of the treatments that were completed in full.

Similarly, descriptive measures will be used to assess treatment pilot data. The proportion of people that rate agreement to statements on treatment content acceptability and usefulness, treatment delivery acceptability, and sham credibility will be assessed. Agreement with treatment acceptability/usefulness and sham credibility statements will be rated using 5-point Likert scales ranging from “strongly agree” to “strongly disagree” in both participants and clinicians.

Note that there will be no efficacy evaluation of pain or physical activity outcomes (or any of the other secondary outcomes).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2018
Actual
13/07/2018
Date of last participant enrolment
Anticipated
Actual
24/08/2018
Date of last data collection
Anticipated
Actual
11/02/2019
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 300037 0
Charities/Societies/Foundations
Name [1] 300037 0
Arthritis Australia
Country [1] 300037 0
Australia
Funding source category [2] 300038 0
University
Name [2] 300038 0
Sansom Institute for Health Research,
Country [2] 300038 0
Australia
Primary sponsor type
Individual
Name
Dr Tasha Stanton
Address
The University of South Australia, School of Health Science, G.P.O. Box 2471, Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 299429 0
None
Name [1] 299429 0
Address [1] 299429 0
Country [1] 299429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300887 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 300887 0
University of South Australia
Ethics and Integrity Services, Human Research Ethics Committee
GPO Box 2471
Adelaide, South Australia 5001
Australia
Ethics committee country [1] 300887 0
Australia
Date submitted for ethics approval [1] 300887 0
Approval date [1] 300887 0
23/02/2018
Ethics approval number [1] 300887 0
HREC200791

Summary
Brief summary
The primary purpose of this pilot study is to assess the feasibility of successfully conducting a randomised controlled trial that investigates the effect of adding Explain Pain (vs adding sham ultrasound) to an individualised, physiotherapist-led physical activity and general education program in people with painful knee osteoarthritis.

Our primary feasibility objectives relate to participant eligibility and recruitment, participant follow-up rates, feasibility of objective physical activity measurement using wrist-based accelerometry in this population (i.e., valid wear time), and the fidelity of intervention delivery.

Our primary pilot objectives relate to the perceived credibility of the sham intervention (inactive ultrasound with inert gel) and the acceptability of Explain pain content and its delivery format for participants and treating clinicians.

Our secondary objectives are to identify barriers to study participation and to determine treatment effect estimates for pain intensity and physical activity. This information will help us to calculate the required sample size for a full-scale randomised controlled trial.

Participants will be randomised to one of two groups: Explain Pain or Standard Education & Sham Ultrasound Control group. Both groups will receive 4, in-person treatment sessions with a physiotherapist, followed by 4 weeks of at-home activities (weekly check-in by physiotherapist). Both groups will receive general education about osteoarthritis and the importance of physical activity for general health and osteoarthritis benefits. Both groups will also receive a graded walking program.

The Explain Pain group will receive enhanced pain education to supplement general education. Specifically, the overall aim of Explain Pain is to shift participants’ conceptualisation of pain from that of a marker of tissue damage to that of a marker of the perceived need to protect the body. The Participants will receive the Explain Pain Handbook. During the at-home sessions, participants will complete an interactive workbook called the Protectometer.

The Standard Education & Sham Ultrasound group will receive standard education about osteoarthritis, pain and physical activity as per Arthritis Australia recommendations. They will also receive sham ultrasound (inactive ultrasound and inert gel) to 4 locations on the most painful knee (5 mins each). This will be performed to match time with the therapist between groups. Participants will receive the Arthritis Australia osteoarthritis and physical activity handbook. During the at-home sessions, participants will complete an general workbook that asks questions about osteoarthritis and activity.

Outcome measures (pain, physical activity, function, pain beliefs, etc..) will be assessed at baseline, at 4 weeks, 8 weeks, and 6 months by an outcome assessor blinded to treatment group. Treatment efficacy will not be evaluated (between group comparisons) given that this is a feasibility study.
Trial website
Trial related presentations / publications
Stanton et al. PAIN Reports 2020; 5(5): e830.
Public notes
Note: the attached protocol includes the participant information sheet, consent form as well as outcome measures used in the study.
Attachments [1] 2868 2868 0 0
/AnzctrAttachments/375526-PROTOCOL_EP FOR KNEE OA_FINAL.pdf (Protocol)

Contacts
Principal investigator
Name 85162 0
Dr Tasha Stanton
Address 85162 0
The University of South Australia
School of Health Sciences
G.P.O. Box 2471
Adelaide, South Australia
5001
Country 85162 0
Australia
Phone 85162 0
+61883022090
Fax 85162 0
Email 85162 0
[email protected]
Contact person for public queries
Name 85163 0
Dr Tasha Stanton
Address 85163 0
The University of South Australia
School of Health Sciences
G.P.O. Box 2471
Adelaide, South Australia
5001
Country 85163 0
Australia
Phone 85163 0
+61883022090
Fax 85163 0
Email 85163 0
[email protected]
Contact person for scientific queries
Name 85164 0
Dr Tasha Stanton
Address 85164 0
The University of South Australia
School of Health Sciences
G.P.O. Box 2471
Adelaide, South Australia
5001
Country 85164 0
Australia
Phone 85164 0
+61883022090
Fax 85164 0
Email 85164 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?
All collected de-identified data
When will data be available (start and end dates)?
October 2020 - October 2025
Available to whom?
Yes, available upon request from other researchers with a defined proposal for data use
Available for what types of analyses?
Meta-analyses/meta-regression
How or where can data be obtained?
Email contact author ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13714Study protocol    375526-(Uploaded-28-09-2021-09-30-46)-Study-related document.pdf



Results publications and other study-related documents

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